Munich, Germany – 09 November 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the enrolment of their first participant in the United States, an important milestone for the i-GAIN natural history study of people who have been diagnosed with geographic atrophy (GA), secondary to age-related macular degeneration (AMD).

The i-GAIN (investigating Geographic Atrophy Insights) study is a non-interventional study for participants who have a confirmed diagnosis of GA. The study, which has surpassed 100 participants in the UK, will now expand to include 10 centres in the United States. i-GAIN is designed to evaluate the relationship between genetics, blood biomarkers evaluated using the proprietary Complement Precision Medicine (CPM) Platform, and phenotypic changes in the eyes of people with GA.  Data from the i-GAIN study will ultimately support the clinical development of CTx001, an innovative gene therapy asset for the treatment of GA, enabling the identification and stratification of patients with complement-driven AMD for future interventional studies.

Dr Parisa Zamiri, Chief Medical Officer at Complement Therapeutics said, “Achieving this milestone is a great step in expanding our study and ensuring we capture meaningful, clinically relevant data to better understand geographic atrophy. We look forward to analysing this extensive database which will provide deeper insights into how the disease progresses.”

“An expanded natural history study will provide an in-depth, data-driven comprehension of a complex and heterogeneous disease that is GA, which will contribute to the clinical development of our innovative complement-targeting gene therapy approach to provide optimised solutions for patients,” said Dr Rafiq Hasan, Chief Executive Officer at Complement Therapeutics.

About the i-GAIN Study

i-GAIN is a multicentre, prospective natural history of people over 18 who have an established clinical diagnosis of GA. No investigational medications or treatments will be provided, as it is a non-interventional study. The study is expected to enrol approximately 250 patients across 12 sites in the United Kingdom and 10 sites in the United States. Patients will undergo assessments at baseline, 6 months and 12 months. For more information about enrolling in the study, please email iGAIN@complementtx.com citing trial identifier number NCT05797896.

About Complement Therapeutics Ltd:

Complement Therapeutics (CTx) is an early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

— Ends —

For more information please visit: https://complementtx.com/

Company Contact

Dr Rafiq Hasan, CEO

Complement Therapeutics Ltd

Email: info@complementtx.com

Munich, Germany – 3^rd August 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the appointment of Dr Parisa Zamiri as its Chief Medical Officer, effective immediately. Dr. Zamiri brings with her extensive experience in biopharmaceutical and small molecule drug discovery and development, drug and device safety, pharmacovigilance, and biomarker development across various therapeutic areas.

Dr. Zamiri joins CTx from Graybug Vision, Inc., where she held the position of Chief Medical Officer and was responsible for all clinical, statistics, regulatory and medical affairs activities, successfully completing phase II development of their lead asset for wet age-related macular degeneration. Prior to Graybug, Dr. Zamiri held the position of Vice President, Global Head of Clinical Development and Therapeutic Area Head for Ophthalmology at Novartis Pharmaceuticals where she oversaw the design and execution of Phase 2b-4 clinical trials in ophthalmic indications including dry eye, retinitis pigmentosa, and age-related macular degeneration.

Dr. Zamiri is a physician-scientist who received her medical degree from the King’s College Hospital, University of London prior to her ophthalmology residency at the North Thames Rotation, London. She then obtained her Ph.D. in ocular immunology at the Schepen’s Eye Research Institute of Massachusetts Eye and Ear, a Harvard Medical School affiliated institute.

“We are excited to welcome Parisa to the CTx team as CMO,” said Dr Rafiq Hasan, Chief Executive Officer. “Parisa’s clinical experience and deep expertise in ophthalmic clinical development will be crucial as we progress with the development of our novel pipeline assets, particularly CTx001 for the treatment of Geographic Atrophy secondary to AMD as well as the ongoing i-GAIN natural history study. We are thrilled to have her on board to support our vision of developing the next generation of complement medicines.”

“I am excited to join CTx to develop medicines for the underserved and ever-growing population with age-related macular degeneration. CTx001 as a single administration gene therapy has the potential to revolutionise the treatment of GA by targeting the complement system. The encouraging results from preclinical studies have shown significant complement modulation and have the potential to offer hope for millions of GA patients worldwide who currently have limited treatment options.” said Dr Parisa Zamiri, Chief Medical Officer. “With its innovative approach, CTx001 has the potential to transform the treatment landscape for GA and improve the quality of life for those affected by this debilitating condition.”

About Complement Therapeutics GmbH:

Complement Therapeutics GmbH (CTx) is a German headquartered early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programs will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK.

–Ends–

For more information please visit: https://complementtx.com/

Company Contact

Dr Rafiq Hasan, CEO and Managing Director

Complement Therapeutics GmbH

Email: info@complementtx.com

Munich, Germany – 13^th June 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the opening of their laboratory at Stevenage Bioscience Catalyst (SBC).  

The state-of-the-art laboratory facility marks a significant milestone for CTx as it expands its research and development capabilities. Equipped with cutting-edge technologies and equipment, the lab will serve as a hub for advancing the development of CTx’s pipeline assets. 

“We are thrilled to announce the opening of our new lab at Stevenage Bioscience Catalyst,” said Dr Dennis Keefe, Chief Scientific Officer of Complement Therapeutics. “This facility will be instrumental in accelerating our research efforts and driving innovation in the field of complement-mediated diseases. With the support of our growing talented team and the collaborative environment fostered at SBC, we are well-positioned to make significant progress in developing novel therapeutics.”

Dr Sally Ann Forsyth OBE, CEO, Stevenage Bioscience Catalyst, said: “We are delighted that Complement Therapeutics has joined our world-class cluster of excellence which accelerates the translation of cutting-edge science to improve people’s health and the quality of their lives. We wish the team every success as they continue to build potentially transformative therapies.” 

The strategic location of the lab within the Stevenage Campus provides CTx with access to a vibrant ecosystem of leading researchers and industry experts. This proximity to scientific expertise and the potential for collaborative partnerships will enhance CTx’s ability to translate scientific discoveries into groundbreaking treatments for diseases with high unmet clinical need.  

About Complement Therapeutics GmbH: 

Complement Therapeutics GmbH (CTx) is a German headquartered early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.  

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programs will evaluate potential therapeutic opportunities in other complement-mediated conditions.  

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease. 

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK. 

About Stevenage Bioscience Catalyst

Stevenage Bioscience Catalyst is a world-leading cluster of global significance and located at the centre of one of the largest groups of cell and gene therapy companies in Europe. It provides a supportive environment to help organisations grow by providing access to specialist equipment, mentoring and finance suited to their stage of development.  Since its opening in 2012, occupier companies have secured £2.9bn in finance making the cluster one of the most attractive for investment in biotechnology in the UK.

–Ends– 

For more information please visit: https://complementtx.com/ 

Company Contact 

Dr Rafiq Hasan, CEO and Managing Director 

Complement Therapeutics GmbH 

Email: info@complementtx.com 

Munich, Germany – 27^th April 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the appointment of Dominic Moreland as its Chief Financial Officer. Dominic brings with him extensive experience in finance and operations, having held senior leadership roles in several biotech companies previously.  

Dominic is a seasoned biopharmaceutical executive with many years experience in the sector and previously served as the finance lead at Autolus Therapeutics through the company’s IPO and NASDAQ listing. He led the MBO and subsequent trade sale of a division of Genzyme Therapeutics UK and prior to that held finance positions with Baxter Healthcare and Zeneca. Dominic is a Chartered Accountant and holds a B.Sc from the London School of Economics. 

“We are thrilled to welcome Dominic to the Complement team as CFO,” said Rafiq Hasan, Chief Executive Officer. “Dominic’s experience in financial management will be invaluable as we continue to grow the organisation and develop our pipeline. He played a critical role in the recent successful Series A funding round and we are excited to have him on board to help transform the treatment landscape for complement-mediated diseases.”  

“Joining Complement Therapeutics at this stage in the company’s development is a truly exciting opportunity. I believe the team has the potential to make a real difference in the lives of patients with complement-mediate diseases, and I am delighted to be part of it. I look forward to working with the great team we have assembled and building a strong financial foundation for the company as we progress to the clinic.” said Dominic Moreland. 

About Complement Therapeutics GmbH: 

Complement Therapeutics GmbH (CTx) is a German headquartered early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.  

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programs will evaluate potential therapeutic opportunities in other complement-mediated conditions.  

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease. 

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK. 

–Ends– 

For more information please visit: https://complementtx.com/ 

Company Contact 

Dr Rafiq Hasan, CEO and Managing Director 

Complement Therapeutics GmbH 

Email: info@complementtx.com 

Munich, Germany – 20^th April 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced that pre-clinical data for its lead asset, CTx001, a gene therapy focused on treating geographic atrophy, a form of dry age-related macular degeneration, will be featured in posters at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2023 to be held on 23-27^th April 2023 in New Orleans, USA.  

ARVO Poster Details: 

Title: CTx001, a gene therapy for the treatment of geographic atrophy in aged-related macular degeneration 

Session: 414, Gene and Cell Therapy, April 26, 2023, from 10:30 AM to 12:30 PM 

Presentation Number: #3852 

Poster Board Number: #B0132 

About Complement Therapeutics GmbH: 

Complement Therapeutics GmbH (CTx) is a German headquartered early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.  

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programs will evaluate potential therapeutic opportunities in other complement-mediated conditions.  

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease. 

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK. 

–Ends– 

For more information please visit: https://complementtx.com/ 

Company Contact 

Dr Rafiq Hasan, CEO and Managing Director 

Complement Therapeutics GmbH 

Email: info@complementtx.com 

• Round led by Gimv, a Belgian based private equity and venture capital firm
• Round comes just 1 year after raising €5 million seed funding in February 2022
• Company aims to transform the treatment of complement mediated conditions

Munich, Germany – 17th April 2023 – Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement mediated diseases, today announced the completion of a €72 million Series A financing. The round was led by Gimv, a Belgian-based private equity and venture capital fund, co-led by Forbion as existing investor and further joined by BioGeneration Ventures (BGV), Panakès Partners, Cambridge Innovation Capital (CIC), Hadean Ventures and Seroba Life Sciences.

With this new round of financing, CTx will continue the development and complete a Phase Ib clinical proof of concept of its lead product CTx001. CTx001 is a highly innovative AAV gene therapy for the treatment of Geograpic Atrophy (GA) secondary to dry age-related macular degeneration (dry-AMD). Additionally, proceeds from this financing will be deployed to grow its laboratory-based activities in Stevenage (UK), evaluate CTx’s pipeline assets for non-ocular indications as well as further develop the novel Complement Precision Medicine (CPM) platform.

CTx was spun out of the University of Manchester with initial funding from BGV in 2021 and subsequently received €5 million seed funding in February 2022 from Forbion and BGV. With that funding, CTx has advanced CTx001 through preclinical proof-of-concept, secured an Innovation Passport by the Medicines and Healthcare products Regulatory Agency (MHRA) and initiated a non-interventional natural history study in the UK (i-GAIN). The i-GAIN study results will help support the clinical development planning for CTx001.

“With a potentially highly differentiated lead asset combined with a precision medicine approach, we are excited by the opportunity to further develop CTx001 for the treatment of GA through to the clinic.” said Dr Rafiq Hasan, CEO and Managing Director at Complement Therapeutics GmbH. “The support of this broad syndicate enables us to generate additional data demonstrating CTx001’s unique and differentiated mechanism of action, with the potential to transform the treatment landscape in geographic atrophy.”

The recent FDA approval of the first intravitreal treatment for GA is a significant milestone for GA patients and the retina community, and further validates the critical role that the complement system plays in the development and progression of GA whilst highlighting the importance of targeting complement as a therapeutic strategy. CTx001 gene therapy with its novel mechanism of action has the potential to provide superior efficacy compared to competitive drugs and to lower the burden of treatment among patients through a “one and done” approach and thereby transforming the treatment landscape in GA.

Michaël Vlemmix, Principal in the Life Sciences platform of Gimv said: “We are proud to have been able to build this syndicate and look forward to supporting Complement Therapeutics in its next phase of development. The company and its team combine deep research insights, strong industry background, and a robust understanding of complement-mediated conditions, in particular GA secondary to AMD. These strengths, coupled with a focus on addressing the significant unmet need in GA, positions the company to change the way the disease is addressed and potentially achieve meaningful therapeutic impact.”

“We are delighted with the rapid progress made by Complement Therapeutics in the last 12 months. Patients impacted by complement-mediated diseases often have to cope with debilitating symptoms throughout their lifetime and this can lead to a significant burden on them and their families. We look forward to supporting the Company as it drives forward a pipeline of novel assets addressing these unmet needs in complement-mediated diseases” said Dr Dmitrij Hristodorov, Partner, Forbion.

Alongside the financing, Michaël Vlemmix (Gimv), Rob Woodman (Panakès), Anne Horgan (CIC) and Roger Franklin (Hadean Ventures) will join the board as new members.

About Complement Therapeutics GmbH:

Complement Therapeutics GmbH (CTx) is a German headquartered early-stage biotechnology company focused on the research and development of novel therapeutics for complement- mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programs will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

The Company has subsidiaries in the UK (Complement Therapeutics Ltd) and in the USA (Complement Therapeutics Inc) as well as research laboratories in Stevenage, UK.

–Ends–

For more information please visit: https://complementtx.com/

Company Contact

Dr Rafiq Hasan, CEO and Managing Director Complement Therapeutics GmbH
Email: info@complementtx.com

London, UK – March 29^th 2023 – Complement Therapeutics Ltd (CTx) and Pharmaron are delighted to announce a strategic partnership for the Development and Clinical Manufacture of lead investigational product (CTx001) – a Gene Therapy for the treatment of Geographic Atrophy (late dry age-related macular degeneration), which causes significant vision loss and is estimated to affect 5 million people globally.

The project commenced in December 2022 with initiation at Pharmaron’s state-of-art gene therapy clinical development and GMP manufacturing facilities in Liverpool, UK. The Pharmaron CMC team has a wealth of technical know-how and experience in the development of ocular gene therapy medicines. 

CTx001 is in pre-clinical development as an Adeno Associated Virus (AAV) based gene therapy for the treatment of Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). CTx001 harnesses the unique mechanism of action of a highly potent complement regulator to maximise efficacy in a broad range of patients with complement-driven GA. This partnership will allow the delivery of clinical-grade drug products for the supply for first-in-human clinical trials anticipated to commence in H2 2024.  

Dr. Rafiq Hasan, CEO of Complement Therapeutics said, “Collaborating with Pharmaron is a critical component in our strategy to bring CTx001 through clinical proof of concept. Their track record in delivering gene therapies for ophthalmic diseases, technical expertise and state-of-the-art facilities make them an ideal partner in delivering a robust and scalable CMC platform. Our team looks forward to a productive and collaborative partnership, accelerating the development of CTx001 in a cost-effective manner, with the ultimate aim to improve the quality of life of patients with GA.”

Dr. Derek Elliison, VP Biologics Services Europe, Pharmaron Biologics & CGT, commented, “I am extremely pleased that Complement Therapeutics, has recognised Pharmaron’s advanced analytical and process development capabilities to develop their lead investigational product. This project is a great fit for our multi-disciplinary expertise team given the many years’ prior experience working on gene therapy ophthalmic indications out of our Liverpool site and we are excited at the opportunity to make a difference in fighting this debilitating cause of vision loss in such a large patient group.

About Complement Therapeutics Ltd:

Complement Therapeutics Ltd (CTx) is an early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

The Company’s lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programs will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable the quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

Contacts

For further information please contact:

Pharmaron:

Ellen Cabral
Senior Marketing Director
Tel: +1 617 901 2216,

Email:ellen.cabral@pharmaron.com

Complement Therapeutics:

Dr Rafiq Hasan

CEO

Email: info@complementtx.com

London England – 09 February 2023 – Complement Therapeutics Ltd (CTx), a preclinical stage biotechnology company, today announced enrolment of the first patient in a natural history study of people who have been diagnosed with geographic atrophy (GA), secondary to age-related macular degeneration (AMD); also called late dry AMD, GA is a disease which causes irreversible blindness and currently has no approved treatments.

The i-GAIN (investigating Geographic Atrophy Insights) study is a one-year natural history study in patients who have a confirmed diagnosis of GA in one or both eyes. The study is designed to evaluate the relationship between genetics, blood biomarkers and phenotypic changes in the eye of people with GA. Data from the i-GAIN study will support the clinical development of CTx001, CTx’s lead gene therapy asset for the treatment of GA, particularly enabling the identification and stratification of patients with complement-driven AMD for future interventional studies.

Dr Marta Ugarte, consultant ophthalmologist and principal investigator of the i- GAIN study said “Today’s announcement is an important milestone in enabling researchers to gain a better understanding of this disease. We look forward to generating and analysing data from the i-GAIN study, which will provide insights into how the disease progresses.”

“A deeper understanding of the natural history of GA will provide important insights supporting the development of innovative medicines which can prevent vision loss in these patients,” said Dr Rafiq Hasan, Chief Executive Officer at Complement Therapeutics.

About the i-GAIN Study

i-GAIN is a multicentre, prospective natural history of people over 18 who have an established clinical diagnosis of GA. No investigational medications or treatments will be provided, as it is a non-interventional study. The study is expected to enrol approximately 250 patients across 12 sites in the United Kingdom. Patients will undergo assessments at baseline, 6 months and 12 months. For more information about enrolling in the study, please email iGAIN@complementtx.com.

About Complement Therapeutics Ltd:

Complement Therapeutics (CTx) is an early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for GA, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

–Ends–

For more information please visit: https://complementtx.com/

Company Contact
Dr Rafiq Hasan, CEO
Complement Therapeutics Ltd
Email: info@complementtx.com

• The Innovate UK EDGE grant funding is awarded to innovative companies looking to benefit from the expertise provided by Catapults or Research & Technology Organisations
• This grant funding further recognises the innovative nature of CTx001, a gene therapy being developed for the treatment of Geographic Atrophy.

London England – 17th November 2022 – Complement Therapeutics Ltd (CTx), a biotechnology company developing novel therapeutics for complement-related diseases, today announced a collaboration with the Cell and Gene Therapy (CGT) Catapult enabled by an Innovate UK EDGE grant funding award. This award allows CTx to benefit from the expertise within CGT Catapult’s Regulatory Affairs and Non-clinical Safety team to evaluate the Company’s non-clinical, chemistry manufacturing and control (CMC), quality and clinical development plans and define a tailored regulatory strategy for its lead product CTx001.

Dr. Rafiq Hasan, CEO at Complement Therapeutics commented: “We are delighted to receive the award from IUK for CTx001, highlighting the innovative potential of this gene therapy for the treatment of GA, a condition with significant unmet need.  We look forward to continuing our collaboration with CGT Catapult, who have been an extended team to us since the formation of the Company, and we plan to strengthen our regulatory strategy through their deep understanding of the global regulatory landscape. CTx aims to maintain a constant dialogue with the regulators to ensure our lead candidate CTx001 reaches the clinic with a robust and validated development plan.’’

About Complement Therapeutics Ltd:

Complement Therapeutics (CTx) is an early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

About Cell and Gene Therapy Catapult:

The Cell and Gene Therapy Catapult is part of the Catapult Network. It was established by, and works in partnership with, Innovate UK.

The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. With over 400 experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation. For more information, please visit https:ct.catapult.org.uk or visit https://www.gov.uk/government/organisations/innovate-uk.

–The End–

For more information please visit: https://complementtx.com/

Company Contact

Dr Rafiq Hasan, CEO

Complement Therapeutics Ltd

Email: info@complementtx.com

• MHRA granted Complement Therapeutics an Innovation Passport under the new accelerated Innovative Licensing and Access Pathway (ILAP)
• ILAP is designed to optimise the development and expedite the evaluation of innovative medicines for patients with high unmet need
• CTx001 is being evaluated as a potential AAV gene therapy for the treatment of visual impairment due to geographic atrophy

London England – 1st November 2022 – Complement Therapeutics Ltd (CTx), a biotechnology company developing novel therapeutics for complement-related diseases, today announced its lead asset CTx001, an AAV-based gene therapy for the treatment of Geographic Atrophy (GA), has been awarded an Innovation Passport by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

CTx001 was awarded the Innovation Passport based on three criteria: that the condition addressed is seriously debilitating with a significant patient need; an advanced therapy medicinal product classified as innovative; and that the medicine has the potential to offer transformative benefits to patients.

“Receiving the Innovation Passport Designation is a key regulatory accomplishment and has the potential to help GA patients in the UK gain faster access to our novel gene therapy,” said Dr Rafiq Hasan, CEO of Complement Therapeutics. “It provides recognition from the MHRA of the unique mechanism of action of CTx001, with the potential to change the treatment landscape for GA patients. We look forward to working with the MHRA and other agencies to advance the CTx001 development programme.”

The Innovation Passport is the first step in the Innovative Licensing and Access Pathway (ILAP) by providing opportunities for enhanced regulatory support from the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and National Health Service (NHS) England. CTx will work with these agencies on a Target Development Profile (TDP) for CTx001, that will set out a roadmap for regulatory and development milestones to enable early patient access in the UK. Other benefits of ILAP, include the potential for a 150-day accelerated Marketing Authorisation Application (MAA) assessment, a rolling review and a continuous risk-benefit assessment.

About ILAP:

The MHRA launched ILAP at the start of 2021 in order to accelerate the development and access to promising medicines in the early stages of development. It provides a single integrated platform for collaboration between the developer of the investigational medicine, the MHRA and its partners. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders.

More background on the ILAP can be found at: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway

About Complement Therapeutics Ltd:

Complement Therapeutics (CTx) is an early-stage biotechnology company focused on the research and development of novel therapeutics for complement-mediated diseases. The Company is a spinout from the University of Manchester and is based on the pioneering research of its founders into novel targets within the complement cascade.

Our lead investigational product (CTx001) is being evaluated as a potential gene therapy for dry age-related macular degeneration/geographic atrophy, a leading cause of blindness. Additional programmes will evaluate potential therapeutic opportunities in other complement-mediated conditions.

The Company is also developing a unique quantification methodology, the Complement Precision Medicine (CPM) platform, to enable quantification of over 30 complement cascade proteins enabling more precise diagnosis and monitoring of disease.

–The End–

For more information please visit: https://complementtx.com/

Company Contact

Dr Rafiq Hasan, CEO

Complement Therapeutics Ltd

Email: info@complementtx.com