Regulus Therapeutics Inc. (RGLS) Wednesday announced positive clinical as well as regulatory updates from its autosomal dominant polycystic kidney disease (ADPKD) program.
Topline results from an interim analysis of fourth cohort of the Phase 1b Multiple Ascending Dose (MAD) study of farabursen for the treatment of autosomal dominant polycystic kidney disease (ADPKD) showed continued mechanistic dose response. Further, Safety and tolerability profile was consistent with earlier cohorts.
Additionally, the company said that it had a successful end-of-Phase 1 meeting with the Food and Drug Administration (FDA) in December last year, in which they have come to an agreement on key components of a Phase 3 single pivotal trial for potential accelerated approval of farabursen. "Following a productive End-of-Phase 1 meeting with the FDA in December along with the interim results announced today, we are encouraged by the feedback from the agency and are excited about the path forward for farabursen in ADPKD," said Jay Hagan, CEO of Regulus.
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