Gemini initiates the largest and most complete longitudinal prospective clinical study to date of subjects with dry Age-Related Macular Degeneration (AMD) who are carriers of high-risk genotypes
Cambridge, Mass., January 7, 2019 – Gemini Therapeutics, a product engine company focused on redefining dry AMD and linked disorders with precision medicine, today announced the initiation of CLARITY, a disease registry and natural history study designed to identify and characterize disease progression in subjects with non-central geographic atrophy (NC-GA) secondary to dry AMD, who are carriers of high-risk genetic variants. CLARITY will be used to inform and optimize the design of future interventional trials.
CLARITY will genetically screen and consent thousands of subjects, and will enroll hundreds based on genetic criteria. The screening process will assess dozens of genetic loci with coverage across all known high-risk genetic variants associated with dry AMD. Subjects will be separated into one of two studies: CLARITY1, a genetic screening and disease registry will evaluate long-term clinical outcomes and disease progression in subjects who are carriers of functionally consequential genetic variants associated with AMD; CLARITY2, a two-year prospective natural history study will evaluate the clinical characteristics and disease progression in subjects who are carriers of high-risk genetic variants in Complement Factor H (CFH).
CLARITY Investigator Dante Pieramici, M.D., Co-Director of the California Retina Research Foundation, partner at California Retina Consultants and Assistant Clinical Professor of Ophthalmology at the Doheny Eye Center in Southern California, said, “This is a very exciting time for individuals with dry AMD and their families, and we are delighted to help support the advancement of this innovative clinical platform designed to understand the underlying mechanism of dry AMD through precision medicine. To date, precision medicine has been limited to selective fields such as oncology, lung and metabolic rare diseases. CLARITY is advancing the field of ophthalmology in the evaluation of complex retinal diseases with the use of a precision medicine approach. The potential impact for patients and their families cannot be overestimated.”
“At Gemini, we see a future where dry AMD therapeutics will be selected for each patient based on what is written into their DNA, and the CLARITY studies are foundational for this future,” said James McLaughlin, President, CEO and Co-Founder of Gemini Therapeutics. “We have built our pipeline from the disease on up, using genetics to select our targets, biology to define our approach and our product engine to create the best therapeutic candidates. We made significant progress in 2018 and are now conducting preclinical development activities on three programs across two distinct AMD populations. With CLARITY, we are now entering the clinic with our ocular platform to define the path for upcoming interventional studies. CLARITY will be the largest and most complete longitudinal prospective clinical studies to date on subjects with high-risk genotypes in dry AMD. We look forward to the insights they will provide both for the CFH-NC-GA population we are pursuing with our lead program, as well as other populations we are focusing on in other programs.”
CLARITY1 is a prospective, multicenter, longitudinal registry, conducted in subjects with NC-GA secondary to dry AMD. Dozens of genetic loci will be assessed during the screening process providing coverage across all known high-risk genetic variants associated with dry AMD. Thousands of subjects will be genetically screened, and hundreds will be enrolled to CLARITY based on genetic criteria.
Subjects in CLARITY1 will be followed for up to six years, contributing data every two years throughout the study unless they qualify for and agree to enter potential ongoing interventional studies for this program. Data will be collected on demographics, medical history, visual function testing, ophthalmic anatomic assessments, multi-modal ocular imaging, quality of life metrics and ocular fluid biomarkers.
CLARITY2, a subset study of CLARITY1, is a prospective, multicenter, natural history study, conducted in subjects with NC-GA secondary to dry AMD. Hundreds of subjects who are carriers of rare and common CFH variants and associated complotypes will be followed in two parallel cohorts.
Subjects will be followed for two years, contributing data every six months throughout the study unless they qualify for and agree to enter potential ongoing interventional studies for this program. Data will be collected on demographics, medical history, visual function testing, anatomic ocular assessments, multi-modal ocular imaging, quality of life metrics and ocular fluid biomarkers.
About Dry AMD
AMD is a progressive retinal disease affecting older adults, and the leading cause of irreversible blindness in the western world affecting millions worldwide. Symptoms, including blurry vision, loss of night vision and loss of central vision, make activities of daily living such as reading, driving and even recognizing faces more difficult over time. Dry AMD results from an interaction of both environmental and genetic risk factors. Aging and smoking confer the strongest non-genetic risk, but genetic risk is significant, with approximately 70% attributable risk of advanced disease due to heritability. Research over the last decade has uncovered multiple genetic variants which can increase risk of developing advanced AMD by up to 20-fold.
About the Gemini Ocular Platform
The Gemini Ocular Platform integrates genetics, biology, and clinical information to provide unprecedented insight into the high-risk, genetically defined subpopulations present within common complex ocular diseases. The platform identifies, functionally evaluates and clinically characterizes genetic variants associated with retinal diseases to define their role in disease pathogenesis and includes custom genetic assays, novel biomarkers, the CLARITY1 registry and the CLARITY2 natural history study.
Gemini Therapeutics is a product engine company focused on redefining AMD and linked disorders with precision medicine. Our ocular therapeutic candidates are matched to molecular abnormalities found in patients with high clinical need and our multimodal product engine has generated a rich pipeline including recombinant proteins, monoclonal antibodies, and gene therapies. Our Ocular Platform designed to provide unprecedented insight into the role of genetic risk in common retinal diseases is in the clinic. Launched with funding from leading life science investors and powered by academic partnerships around the world, we are developing a series of first-in-class therapeutics for retinal diseases and complement-mediated systemic diseases.
For more information, visit www.GeminiTherapeutics.com.
Ten Bridge Communications