Disc Medicine Phase 3 APOLLO Trial Meets All Endpoints for Bitopertin
Disc Medicine, Inc. (IRON) announced that its pivotal Phase 3 APOLLO trial evaluating bitopertin in patients with erythropoietic protoporphyria and X-linked protoporphyria (EPP/XLP) met all primary and secondary endpoints. Bitopertin is an oral GlyT1 inhibitor being developed for these rare conditions.
The successful late-stage trial validates the company's lead drug candidate following earlier Phase 2 testing. EPP and XLP are rare diseases with limited treatment options, and bitopertin's oral administration offers a convenient dosing option for patients.
Following the trial outcome, Disc Medicine plans to resubmit a New Drug Application to the U.S. Food and Drug Administration by the end of 2026. The company expects an FDA regulatory decision by mid-2027. Shares of Disc Medicine were last trading at $56.84, up 0.34% on the day.
Key points
- The Phase 3 APOLLO trial of bitopertin met all primary and secondary endpoints in EPP/XLP patients.
- Bitopertin is an oral GlyT1 inhibitor offering convenient dosing for patients with rare diseases.
- Disc Medicine plans to resubmit a New Drug Application to the FDA by the end of 2026.
- An FDA regulatory decision on bitopertin is expected by mid-2027.
Written by our AI from expert market sources across the web. It can contain mistakes: check the facts before acting on them. Write-ups powered by the free AI API at FreeTheAI.org
How we writeDisclaimerQuestions and answers
What were the results of Disc Medicine's Phase 3 APOLLO trial?
The pivotal Phase 3 APOLLO trial evaluating bitopertin in EPP/XLP patients met all primary and secondary endpoints.
When does Disc Medicine plan to submit bitopertin to the FDA?
Disc Medicine plans to resubmit its New Drug Application to the FDA by the end of 2026, with a decision expected by mid-2027.
What is bitopertin and how is it administered?
Bitopertin is an oral GlyT1 inhibitor designed as a convenient treatment for patients with EPP/XLP.