Orvida Pharma's KM-023 (ontivatrep) has been accepted into the FDA's Rare Disease Evidence Principles process for Olmsted syndrome. Topline results from the Phase 1b clinical trial are expected by the end of 2026.
Topline results from Phase 1b clinical trial in patients with Olmsted syndrome anticipated around year-end 2026 · NESS ZIONA, Israel, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Orvida Pharma, a clinical-stage biotechnology company developing first- and best-in-class treatments for rare and severe genetic skin diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted KM-023 (ontivatrep), the Company’s lead oral investigational therapy ... Topline results from Phase 1b clinical trial in patients with Olmsted syndrome anticipated around year-end 2026 · NESS ZIONA, Israel, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Orvida Pharma, a clinical-stage biotechnology company developing first- and best-in-class treatments for rare and severe genetic skin diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted KM-023 (ontivatrep), the Company’s lead oral investigational therapy for Olmsted syndrome, into the FDA’s Rare Disease Evidence Principles (RDEP) process. FDA’s Rare Disease Evidence Principles (RDEP) process aims to provide greater speed and predictability in the review of therapies for rare diseases with... Orvida’s management team comprises industry leaders with deep expertise in drug discovery, dermatological pharmaceutical development, and rare disease therapeutics. ... Investors and Media Marcy Nanus Managing Partner Trilon Advisors, LLC [email protected] GlobeNewswire · September 15, 2026 07:30 ET | Source: Orvida Pharma Ltd · Orvida Pharma Announces Interim Financing Led by Recordati to Advance Ontivatrep Development for Rare Genetic Skin Diseases · Proceeds to support continued clinical development of ontivatrep, an oral TRPV3 inhibitor, with Phase 1b topline results in Olmsted syndrome expected by the end of 2026 NESS ZIONA, Israel, Sept. There are currently no approved therapies for Olmsted syndrome. In April 2026, Orvida reported favorable Phase 1a safety data for ontivatrep from a randomized, placebo-controlled study in 30 healthy volunteers. The Company is currently conducting a Phase 1b clinical trial in patients with Olmsted syndrome in Europe and the United States.
Original title: “Orvida Pharma Announces FDA Acceptance of KM-023 (ontivatrep) into Rare Disease Evidence Principles Process for Olmsted Syndrome”