– A single intravitreal injection of GEM103 (recombinant human complement Factor H) met safety endpoint –
– No dose-limiting toxicities, and no treatment-related adverse events in patients with genetically defined dry age-related macular degeneration (AMD) and central geographic atrophy (GA) –
– Extended supraphysiologic physiologic levels of CFH –
– Data presented during the virtual 2020 Annual Meeting of the American Academy of Ophthalmology by Arshad M. Khanani, MD, MA –
CAMBRIDGE, Mass. & SAN FRANCISCO–(BUSINESS WIRE)–Gemini Therapeutics, a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), today announced that the Phase 1 study of GEM103, the Company’s investigational treatment for dry AMD, met all its endpoints. Results demonstrate that in 12 patients receiving a single intravitreal (IVT) injection of GEM103, there were no dose-limiting toxicities or treatment-related adverse events. Pharmacokinetic and exploratory biomarkers as measured in the aqueous humor (AH) from patients enrolled in the Phase 1 single ascending dose (SAD) study is being presented during a virtual poster session at the 2020 Annual Meeting of the American Academy of Ophthalmology (AAO).
“These results are important, as they demonstrate the promise of GEM103 as a potential treatment for patients with dry AMD who have complement factor H (CFH) loss of function gene variants associated with their disease,” said Arshad M. Khanani, MD, MA, Director of Clinical Research at Sierra Eye Associates and Clinical Associate Professor of Ophthalmology, University of Nevada. “As a recombinant form of human CFH, GEM103 can precisely target the underlying genetics of these patients. GEM103’s promising safety profile in Phase 1 is a critical step forward as therapeutic progresses into Phase 2a.”
Results showed that, in the four ascending single IVT doses tested (50, 100, 250 and 500 µg of GEM103 in a 50µL dose volume), there were no inflammation, anti-drug antibody, or treatment-related adverse events. All dose levels were well-tolerated, with no changes to intraocular pressures in post injection measurements. In this single dose, open-label study, visual acuity was generally maintained or improved in the majority of patients with advanced central GA. Procedures (IVT administration and sampling of the aqueous humor) were also well-tolerated. In addition, the study demonstrated that dose-dependent supraphysiological levels of CFH were achieved, and AH biomarker changes following GEM103 administration support the mechanism of action of GEM103. (Read more…) The tolerability, PK and impact on biomarkers of complement activity at all dose levels support continued clinical development.
“We are extremely pleased that these results have supported advancing GEM103 into a Phase 2a study in a genetically-defined AMD population,” said Jason Meyenburg, CEO of Gemini Therapeutics. “Gemini continues to incorporate its insights in genetics and biology to pioneer precision medicines to restore regulation of the complement system in the eye and throughout the body.”
Gemini is currently evaluating GEM103 in the Phase 2a ReGAtta clinical trial, a multi-center, open-label, multiple dose escalation study in patients with GA secondary to dry AMD. The study is being conducted in a genetically-enriched population including individuals who participated in the Phase 1 study, as well as a treatment-naïve patients. The study will evaluate the impact of monthly GEM103 dosing on safety and tolerability, pharmacokinets and exploratory biomarkers, and measures of visual function relevant in the population.
About Gemini Therapeutics
Gemini Therapeutics is a clinical stage precision medicine company developing novel therapeutic compounds to treat genetically defined age-related macular degeneration (“AMD”). Gemini’s lead candidate, GEM103, is a recombinant form of the human complement factor H protein (“CFH”), and is designed to address both complement hyperactivity and restore retinal health in patients with AMD. GEM103 is currently in a Phase 2a trial in dry AMD patients with a complement factor H mutation. The company has generated a rich pipeline including recombinant proteins, gene therapies, and monoclonal antibodies. Gemini’s CLARITY natural history study is designed to provide unprecedented insight into the role of genetic risk in common retinal diseases and began in December 2018.
For more information, visit www.geminitherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the proposed business combination, including the timing and structure of the business combination, the proceeds of the business combination, the initial market capitalization of the Combined Company and the benefits of the business combination, as well as statements about the potential attributes and benefits of Gemini’s product candidates and the format and timing of Gemini’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the ability to complete the business combination due to the failure to obtain approval from FS Development Corp.’s shareholders or satisfy other closing conditions in the Merger Agreement, the occurrence of any event that could give rise to the termination of the Merger Agreement, the ability to recognize the anticipated benefits of the business combination, the outcome of any legal proceedings that may be instituted against FS Development Corp. or Gemini following announcement of the proposed business combination and related transactions, the impact of COVID-19 on Gemini’s business and/or the ability of the parties to complete the business combination, the ability to obtain or maintain the listing of FS Development Corp.’s common stock on Nasdaq following the proposed business combination, costs related to the proposed business combination, changes in applicable laws or regulations, the possibility that FS Development Corp. or Gemini may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those to be included under the header “Risk Factors” in the registration statement on Form S-4 to be filed by FS Development Corp. with the SEC and those included under the header “Risk Factors” in the final prospectus of FS Development Corp. related to its initial public offering. Most of these factors are outside of FS Development Corp.’s and Gemini’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Contacts
Gemini Investor Contact:
Argot Partners
Sherri Spear
212-600-1902
gemini@argotpartners.com
Gemini Media Contact:
Argot Partners
Joshua Mansbach
212-600-1902
gemini@argotpartners.com