Complement Therapeutics Enrols First US Participant in the Non-interventional i-GAIN Study of People Diagnosed with Geographic Atrophy
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.
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For more information please visit: https://complementtx.com/
Dr Rafiq Hasan, CEO
Complement Therapeutics Ltd