Regulus Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of Lademirsen for Alport Syndrome
–Final data and potential for $25m milestone anticipated in H1 2023–
Excerpt from the Press Release:
SAN DIEGO, Feb. 24, 2022 /PRNewswire/ — Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the “Company” or “Regulus”), today announced the completion of enrollment in the Phase 2 HERA clinical study evaluating lademirsen (RG-012) for the treatment of adult patients with Alport Syndrome under the Company’s Collaboration and License Agreement with Sanofi.
“We value our collaboration with Sanofi and continue to be proud of the steady progress being made not only in this study, but also in our technology to treat kidney disease,” said Jay Hagan, President and Chief Executive Officer of Regulus Therapeutics. “With final data for this Phase 2 trial expected in the first half of next year, this study is a critical step in our effort to improve the lives of patients suffering from Alport Syndrome, a life-threatening, genetic rare nephrology disease for which there are no currently available treatments.”
Lademirsen is a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of miR-21. Initiated in September 2017, the HERA study is a global, randomized, placebo-controlled Phase 2 study designed to assess the safety and tolerability of lademirsen, as well as the efficacy in reducing the decline in renal function in adult patients with Alport Syndrome. The Company expects HERA results in the first half of 2023.
In 2020, Regulus achieved $10 million in milestone payments associated with the completion of transfer and verification of certain materials as well as an interim enrollment milestone from Sanofi for its progress with the HERA study. Under the terms of the Collaboration and License Agreement, the Company is also eligible to receive an additional $25 million upon successful completion of the ongoing HERA study.
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