Gemini Therapeutics Announces Successful Type C Meeting with FDA for Bitopertin in Erythropoietic Protoporphyria and X-linked Protoporphyria

Gemini Therapeutics, a clinical-stage biopharmaceutical company, recently disclosed positive outcomes from its Type C gathering with the U.S. Food and Drug Administration (FDA) to discuss the APOLLO post-marketing confirmatory trial for bitopertin, focusing on Erythropoietic Protoporphyria (EPP) and X-linked Protoporphyria (XLP). This progression surfaced as part of a current report on Form 8-K, offering important insights into the company’s future directions and regulatory collaborations.

In the disclosure, Gemini Therapeutics, formerly known as Disc Medicine, Inc., shared its plans following the Type C meeting. The key takeaways include aligning on a study design for the APOLLO trial, emphasizing various aspects such as co-primary endpoints, dosage selection, treatment duration, patient inclusion criteria, and the study’s structure. Notably, the trial is set to encompass approximately 150 patients, with a randomized 1:1 setup, and will be a double-blind, placebo-controlled study.

Moreover, the company outlined its intentions to commence the APOLLO trial by mid-2025, with sites earmarked across regions like the United States, Canada, Europe, and Australia. Gemini Therapeutics envisions submitting a New Drug Application (NDA) for bitopertin in EPP and XLP during the second half of 2025 under the Accelerated Approval Program, aiming to accelerate the treatment’s regulatory pathway.

In light of these developments, the company provided a comprehensive cautionary statement concerning forward-looking statements. It addressed potential risks and uncertainties, emphasizing the importance of remaining updated on new information, future events, and legal obligations.

Gemini Therapeutics, intent on progressing its novel treatments for hematologic disorders, continues to reaffirm its commitment to advancing clinical studies and potential therapies through robust collaborations and regulatory engagements. Looking ahead, the company remains focused on driving innovation and delivering impactful solutions to patients in need of advanced healthcare avenues.

For further details on Gemini Therapeutics’ recent developments and future plans, interested individuals can access the detailed press release attached as Exhibit 99.1 to the Form 8-K filing on the Securities and Exchange Commission’s database.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Gemini Therapeutics’s 8K filing here.

Gemini Therapeutics Company Profile

Gemini Therapeutics, Inc, a clinical stage precision medicine company, engages in developing various therapeutic compounds for treating genetically defined age-related macular degeneration (AMD). Its lead candidate is GEM103, a recombinant form of the human complement factor H protein to treat dry AMD patients.