Idorsia Announces Positive Phase 3 Results for Lucerastat in Fabry Disease

Reuters01-12

Idorsia Announces Positive Phase 3 Results for Lucerastat in Fabry Disease

Idorsia Ltd. has announced the publication of results from the pivotal Phase 3 MODIFY study and its open-label extension evaluating lucerastat, an oral substrate reduction therapy, in adults with Fabry disease. The results, published in Nature Communications, demonstrate lucerastat's potential to address unmet needs in Fabry disease, particularly for patients with renal impairment. The data indicate a marked attenuation of kidney function loss in patients with impaired renal function or rapidly deteriorating eGFR at baseline, suggesting a potential disease-modifying effect. The results have informed the design of a new Phase 3 program, and Idorsia is working with health authorities, including the US FDA, to determine the optimal regulatory pathway to approval. A post-trial access program is being established for participants as the open-label extension study concludes.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Idorsia Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001158702-en) on January 12, 2026, and is solely responsible for the information contained therein.

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The results, published in Nature Communications, demonstrate lucerastat's potential to address unmet needs in Fabry disease, particularly for patients with renal impairment. The data indicate a marked attenuation of kidney function loss in patients with impaired renal function or rapidly deteriorating eGFR at baseline, suggesting a potential disease-modifying effect. The results have informed the design of a new Phase 3 program, and Idorsia is working with health authorities, including the US FDA, to determine the optimal regulatory pathway to approval. A post-trial access program is being established for participants as the open-label extension study concludes.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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