India, July 22 -- 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 Gl...