Disc Medicine to Host Conference Call on End of Phase 2 FDA Meeting for Bitopertin in Erythropoietic Protoporphyria (EPP)

Rhea-AI Summary

Disc Medicine (NASDAQ:IRON) announced it will host a conference call on November 4, 2024, at 8:00 am EST to discuss feedback from its end-of-Phase 2 meeting with the FDA regarding bitopertin for Erythropoietic Protoporphyria (EPP). The company, which focuses on developing treatments for serious hematologic diseases, will make the call available through registration on their investor relations website.

Positive

• Company completed End of Phase 2 FDA meeting for bitopertin in EPP, indicating progress in clinical development
• Advancement to discussion of Phase 3 plans suggests positive Phase 2 outcomes

Negative

• None.

WATERTOWN, Mass., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, will host a conference call to discuss feedback received from its end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). The conference call will be held on Monday, November 4, at 8:00 am EST.

Conference Call Information

Please register for the event on the Events and Presentations page of Disc’s website at https://ir.discmedicine.com/.

About Bitopertin

Bitopertin is an investigational, clinical-stage, orally administered inhibitor of glycine transporter 1 (GlyT1) that is designed to modulate heme biosynthesis. GlyT1 is a membrane transporter expressed on developing red blood cells and is required to supply sufficient glycine for heme biosynthesis and support erythropoiesis. Disc is planning to develop bitopertin as a potential treatment for a range of hematologic diseases including erythropoietic porphyrias, where it has potential to be the first disease-modifying therapy. Bitopertin has been studied in multiple clinical trials in patients with EPP, including the Phase 2 open-label BEACON trial, the Phase 2 double-blind, placebo-controlled AURORA trial, and an open-label extension HELIOS trial.

Bitopertin is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide. Disc obtained global rights to bitopertin under a license agreement from Roche in May 2021.

About Erythropoietic Protoporphyria (EPP) and X-linked Protoporphyria (XLP)

Erythropoietic protoporphyria (EPP) and X-linked Protoporphyria (XLP) are rare, debilitating and potentially life-threatening diseases caused by mutations that affect heme biosynthesis, resulting in the accumulation of a toxic, photoactive intermediate called protoporphyrin IX (PPIX). This causes severe reactions when patients are exposed to sunlight, characterized by excruciating pain, edema, burning sensations and potential blistering and disfigurement. PPIX also accumulates in the hepatobiliary system and can result in complications including gallstones, cholestasis, and liver damage in 20-30% of patients and in extreme cases liver failure. Current standard of care involves extreme measures to avoid sunlight, including restricting outdoor activities to nighttime, use of protective clothing and opaque shields, and pain management. This has a significant impact on the psychosocial development, quality of life, and daily activities of patients, particularly in young children and families. There is currently no cure for EPP and only one FDA-approved therapy, a surgically implanted synthetic hormone designed to stimulate melanin production called Scenesse® (afamelanotide).

About Disc Medicine

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit www.discmedicine.com.

Media Contact

Peg Rusconi
Deerfield Group
peg.rusconi@deerfieldgroup.com

Investor Relations Contact

Christina Tartaglia
Precision AQ
christina.tartaglia@precisionaq.com

FAQ

When is Disc Medicine's conference call to discuss FDA feedback for bitopertin?

Disc Medicine's conference call is scheduled for Monday, November 4, 2024, at 8:00 am EST.

What is the purpose of IRON's end-of-Phase 2 FDA meeting?

The end-of-Phase 2 meeting with the FDA was to discuss feedback regarding bitopertin's development for treating Erythropoietic Protoporphyria (EPP).

How can investors access Disc Medicine's (IRON) conference call?

Investors can access the conference call by registering through the Events and Presentations page on Disc Medicine's website at ir.discmedicine.com.