Disc Reports Topline Results From Phase 2 AURORA Study Of Bitopertin In Patients With Erythropoietic Protoporphyria; Met Primary Endpoint, Demonstrating Dose-Dependent, Statistically Significant Reductions In Protoporphyrin IX; Improved Measures Of Light Tolerance, Including The Key Secondary Endpoint
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Disc Medicine, Inc. (NASDAQ:IRON) announced positive topline results from the Phase 2 AURORA study of bitopertin in Erythropoietic Protoporphyria (EPP) patients. The study met its primary endpoint, showing significant reductions in protoporphyrin IX (PPIX) levels and improvements in light tolerance and phototoxic reactions with pain, particularly at the 60 mg dose. However, some secondary endpoints did not achieve statistical significance due to a strong placebo response. The company plans further analysis and discussions with regulators to define future study endpoints.
April 01, 2024 | 12:13 pm
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Disc Medicine, Inc. (NASDAQ:IRON) announced successful Phase 2 results for bitopertin in EPP, showing significant efficacy and safety, with plans for further development.
The positive outcome of the AURORA study for bitopertin in treating EPP, a rare condition, demonstrates Disc Medicine's potential in the hematologic disease market. Meeting the primary endpoint and showing significant improvements in patient outcomes are critical for the drug's development and potential approval. Although some secondary endpoints did not meet statistical significance, the overall positive results and the company's commitment to further analysis and development could positively impact investor sentiment and the company's stock price in the short term.
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