Gemini Therapeutics (GMTX) Issues GEM103 Program Update

Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage precision medicine company developing innovative treatments for genetically-defined age-related macular degeneration (AMD), today announced updates from its ongoing phase 2a clinical studies of GEM103 and strategic evaluation of GEM103’s clinical development program.

GEM103 Phase 2a ReGAtta Study Update

Ongoing analysis of the 62 patients enrolled in the ReGAtta study continues to show that more than nine months of GEM103 exposure has been generally well-tolerated, able to durably reduce biomarkers of complement activation, and able to maintain supraphysiological levels of Complement Factor H (CFH). ReGAtta, an open-label, non-controlled study, was designed to evaluate GEM103’s safety and pharmacokinetics (PK) over multiple intravitreal injections.

GEM103 Phase 2a as an Add-On to Anti-VEGF Therapy for the Treatment of Wet AMD Study Update

In December 2021, the Company received six-month data for the 50 patients enrolled in the wet AMD study. This study was designed to investigate the safety and tolerability of GEM103 as an adjunct to standard of care aflibercept therapy, with patients randomized 2:1 between a GEM103 plus aflibercept arm and a sham comparator plus aflibercept arm. Interim analysis showed that intravitreal GEM103 plus aflibercept was generally well-tolerated, and the safety profile was generally consistent with the sham plus aflibercept arm. Patients in this study were dosed every other month concurrently with aflibercept. CFH levels remained supraphysiologic and greater than five times above baseline at the trough timepoints throughout the six months.

GEM103 Study Plans

Having achieved the ReGAtta study’s primary goal of assessing GEM103’s safety and tolerability, as well as the primary goal of assessing GEM103’s safety and tolerability as an add-on to aflibercept for the treatment of wet AMD, the Company will end both of these ongoing Phase 2a studies with patients returning for a final safety visit.

“The ReGAtta and wet AMD clinical studies have achieved their intended purpose of evaluating GEM103’s safety and tolerability, and have also provided data indicating that GEM103 had biological activity and sustained supraphysiologic PK levels at both monthly and every-other-month doses,” stated Jason Meyenburg, Gemini’s Chief Executive Officer. “We want to express our gratitude to the patients who participated in these studies as well as the investigators and site staff conducting the studies. We are actively evaluating next steps with GEM103’s continued clinical development and intend to provide an update by the end of the first quarter 2022.”

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