Disc Medicine Reports Topline Results From Phase 2 AURORA Study Of Bitopertin - Quick Facts

(RTTNews) - Disc Medicine, Inc. (IRON) reported topline data from AURORA, a phase 2 study of bitopertin in patients with Erythropoietic Protoporphyria. The study met primary endpoint, showing dose-dependent, statistically significant reductions in protoporphyrin IX compared to placebo in both 20 mg and 60 mg dose groups.

"This study has confirmed that bitopertin significantly reduces the toxic metabolite, PPIX, in patients with EPP, and we have shown that bitopertin-treated patients experience improvements in the clinically meaningful outcomes of Patient Global Impression of Change and the number and rate of phototoxic reactions with pain, with the 60 mg dose reaching statistical significance compared to placebo," said John Quisel, President and Chief Executive Officer.

On the key secondary endpoint of cumulative time in sunlight on days without pain, bitopertin patients had a positive response consistent with BEACON results, but the endpoint did not meet statistical significance, the company said.

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