Clinical Trials

Date: 2020-01-09

Type of information: Initiation of patient enrollment

phase: 1

Announcement: initiation of patient enrollment

Company: Gemini Therapeutics (USA)

Product: GEM103

Action mechanism:

• recombinant protein. GEM103 is a fully functional recombinant native CFH protein intended to address dysregulation caused by loss of CFH function variants in the eyes of AMD patients.

Disease: geographic atrophy (GA) secondary to dry AMD.

Therapeutic area: Ophthalmological diseases

Country: USA

Trial details:

• The study is designed to identify the maximum tolerated dose for intravitreal administration of GEM103 in subjects with geographic atrophy secondary to dry AMD. Safety and tolerability of a single dose of GEM103 will be assessed based on the occurrence of dose-limiting toxicities. Each subject will be followed for safety, pharmacokinetic, clinical, and biomarker evaluations. Three escalating dose cohorts are planned. The study targets enrolment of approximately 9 patients with dry AMD who have known CFH mutations. (NCT04246866)

Latest news: • On January 9, 2020, Gemini Therapeutics, a clinical stage precision medicine company developing innovative treatments for dry age-related macular degeneration (AMD) and linked ocular disorders, announced it has initiated enrollment in its Phase 1 study of GEM103, a recombinant, native Complement Factor H (CFH) for the treatment of dry age-related macular degeneration. CFH risk variants are reported to occur in greater than 40% of patients with dry AMD and are strongly associated with the risk of developing the disease. The complement system, of which CFH is a modulator, is dysregulated in patients with these risk variants and results in amplification of aberrant inflammatory responses in the eye. Over time this dysregulation leads to damage to the macular region of the retina.  

Is general: Yes