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PureTech Health PLC on Monday said its idiopathic pulmonary fibrosis drug candidate deupirfenidone has cleared a key regulatory milestone, with the US Food & Drug Administration backing progression into a pivotal phase 3 trial planned for the first half of 2026. The Boston, Massachusetts-based biotech and pharmaceutical firm said it has completed its end-of-phase-2 meeting with the FDA, which provided ‘helpful feedback’ on the design of the phase 3 Surpass-ipf trial and supported the use of a streamlined 505(b)(2) regulatory pathway. PureTech said that, based on the agency’s guidance, successful results from the single phase 3 study could be sufficient to support potential registration. Deupirfenidone, a deuterated form of the approved IPF drug pirfenidone, is being advanced by Celea Therapeutics, a PureTech-founded entity that expects to finalise financing in early 2026 to enable the phase 3 trial to begin in the first half of the year. Celea Chief Executive Officer Sven Dethlefs said the FDA discussion ‘provided helpful feedback on key elements of our phase 3 programme and the overall data expectations for registration’. Dethlefs added that the upcoming trial ‘builds on the strong foundation established by the phase 2b Elevate Ipf trial, which demonstrated deupirfenidone’s robust and durable treatment effect’. The phase 3 study will compare deupirfenidone 825 mg three times daily to pirfenidone 801 mg three times daily in adults with IPF who are not on background therapy. The primary endpoint will measure the change in forced vital capacity over 52 weeks. PureTech highlighted that in the earlier Elevate Ipf trial, patients treated with deupirfenidone saw a slower rate of lung-function decline than those receiving pirfenidone or placebo. PureTech shares were up 3.0% at 125.60 pence on Monday afternoon in London. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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