recombinant complement factor H (GEM103) / Disc Medicine - LARVOL DELTA

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P2 | N=50 | Terminated | Sponsor: Gemini Therapeutics, Inc. | Completed ➔ Terminated | Trial primary completion date: Sep 2021 ➔ Jan 2022; Sponsor decision

Trial primary completion date • Trial termination • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Phase I, Single Ascending Dose Study of GEM103 (Recombinant Human Complement Factor H) in Patients with Geographic Atrophy. (PubMed, Ophthalmol Sci) - P1 | "CFH levels in AH were increased and stable for 8 weeks, with pharmacodynamic data suggesting that GEM103 restored complement regulation. These results support further development in a repeat-dose trial in patients with GA with AMD."

Journal • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Immunology • Inflammation • Macular Degeneration • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

REGATTA: A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Dry Age-related Macular Degeneration (clinicaltrials.gov) - P2 | N=62 | Terminated | Sponsor: Gemini Therapeutics, Inc. | Active, not recruiting ➔ Terminated; no further benefit

Trial termination • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Gemini Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A novel full-length recombinant human complement factor H (CFH; GEM103) for the treatment of age-related macular degeneration shows similar in vitro functional activity to native CFH. (PubMed, Curr Eye Res) - "GEM103, a recombinant CFH developed by Gemini Therapeutics, shows activity profiles comparable to sdCFH in all complement-related assays employed in this study, suggesting that GEM103 is equivalent to the native glycoprotein in terms of its in vitro functional activity. These results support further study of GEM103 as a potential therapy for AMD."

Journal • Preclinical • Age-related Macular Degeneration • Hematological Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders

Phase 2a Open-Label Study of GEM103 in Genetically Selected GA Subjects: Study Outline, Baseline Characteristics and Update (AAO 2021) - "Conclusion This Phase 2a (ReGAtta) study uses a precision medicine strategy to evaluate a new therapy. Additional data after multiple GEM103 IVT dosing will be presented at the meeting."

Clinical • P2a data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology

Gemini Therapeutics Announces Presentation of Previously Released Data from Its Ongoing Phase 2a Study of GEM103 at EURETINA 2021 Virtual (Businesswire) - "Gemini Therapeutics, Inc...today announced that Raj Maturi, M.D....presented Gemini's previously released initial results from its ongoing Phase 2a study at EURETINA 2021 Virtual held from September 9-12, 2021...."

Announcement

Gemini Therapeutics Announces Initial Data From Its Ongoing Phase 2a Study of GEM103 in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (Businesswire) - P2, N=62; ReGAtta (NCT04643886); Sponsor: Gemini Therapeutics; "Patients enrolled in ReGAtta had a mean age of 78 and GA secondary to dry AMD in the study eye with 63% of patients also having GA in the fellow eye. Choroidal neovascularization (CNV) in the study eye was an exclusion criterion, however 30% of patients had a history of CNV in the fellow eye at baseline. Among the baseline characteristics in the study eye, mean best corrected visual acuity (BCVA) score, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters, at enrollment was 61.5 (with a range of 14-86)."

P2a data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology • Retinal Disorders

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P2; N=50; Active, not recruiting; Sponsor: Gemini Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: May 2021 ➔ Sep 2021

Clinical • Enrollment closed • Trial primary completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

REGATTA: A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Dry Age-related Macular Degeneration (clinicaltrials.gov) - P2; N=62; Active, not recruiting; Sponsor: Gemini Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Feb 2021 ➔ Feb 2022

Clinical • Enrollment closed • Trial primary completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Gemini Therapeutics, Inc.; Trial primary completion date: Sep 2021 ➔ May 2021

Clinical • Trial primary completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

[VIRTUAL] Anti-angiogenic activity of Complement Factor H in a laser-induced choroidal neovascularization mouse model (ARVO 2021) - "The non-canonical functions of CFH in the eye are also of interest, as recombinant human CFH (rhCFH; GEM103) is in development for the treatment of geographic atrophy in a genetically-defined age-related macular degeneration population... CNV severity was significantly reduced in rhCFH-treated mice compared to PBS group while being similar to aflibercept-treated controls, as measured by FA grading, OCT area, and ISB4 staining. These results demonstrate that IVT administration of rhCFH can provide anti-angiogenic effects in the eye and would not pose an increased risk of CNV development. In contrast, treatment with PEGylated molecules, has a potential to enhance VEGF secretion from RPE cells."

Preclinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Gemini Therapeutics Announces Presentation of Preclinical Data at 2021 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (Businesswire) - “Gemini Therapeutics…announced the presentation of preclinical data at the 2021 Association for Research in Vision and Ophthalmology (ARVO) Virtual Annual Meeting, held May 1 to 7, 2021. The poster, titled ‘Anti-angiogenic activity of Complement Factor H in a laser-induced choroidal neovascularization mouse model,’ demonstrated that human recombinant Complement Factor H (rhCFH) reduced the severity of CNV compared to control…Results from this study in a laser-induced mouse model of wet AMD demonstrated that GEM103 reduced CNV severity comparable to aflibercept-treated control groups as measured by fluorescent angiography (FA) and optical coherence tomography (OCT).”

Preclinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Gemini Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Gemini Therapeutics, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P2; N=45; Not yet recruiting; Sponsor: Gemini Therapeutics, Inc.

Clinical • New P2 trial • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Multiple Dose Study of Repeat Intravitreal Injections of GEM103 in Dry Age-related Macular Degeneration (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Gemini Therapeutics, Inc.

Clinical • New P2 trial • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

[VIRTUAL] PO389: A Phase 1, Single Ascending Dose Study of GEM103 (Recombinant Human CFH) in Patients With GA (AAO 2020) - "Conclusion Available results from this study suggest that treatment with GEM103 appears to be safe. Safety results including DLTs, ocular and systemic AEs, immunogenicity, along with PK, and complement biomarker data will be provided at the meeting."

Clinical • P1 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology

First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Gemini Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Sep 2020 ➔ Dec 2020; Trial primary completion date: Sep 2020 ➔ Dec 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Gemini Therapeutics, Inc.; Trial completion date: May 2020 ➔ Sep 2020; Trial primary completion date: May 2020 ➔ Sep 2020

Clinical • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Gemini Therapeutics, Inc.

New P1 trial