Disc Medicine To Seek FDA Approval For Bitopertin In EPP, A Painful Sunlight Sensitivity Disorder

(RTTNews) - Disc Medicine Inc. (IRON) is planning to submit a New Drug Application for its investigational oral drug Bitopertin in Erythropoietic Protoporphyria in October of this year.

Erythropoietic protoporphyria (EPP) is a rare, debilitating, and potentially life-threatening disease caused by mutations that affect heme biosynthesis, resulting in the accumulation of a toxic, photoactive intermediate called protoporphyrin IX (PPIX). When these patients are exposed to sunlight, they experience excruciating pain, edema, burning sensations, and potential blistering and disfigurement.

Currently, Afamelanotide, a surgically implanted tanning agent, is the only FDA-approved therapy for EPP.

Bitopertin works by selectively inhibiting GlyT1, a key membrane transporter required to supply developing red blood cells with sufficient glycine to support erythropoiesis.

The company intends to seek FDA approval for Bitopertin, under the accelerated pathway, based on results from its phase II trials, which demonstrated significant, consistent reductions in protoporphyrin IX (PPIX) levels and improvements in sunlight tolerance.

IRON has traded in a range of $30.82 to $68.73 in the last 1 year. The stock closed yesterday's trading at $59.38, up 2.79%.