First Olmsted syndrome patient dosed in global Phase 1b study
Company now operating under its new name, Orvida Pharma
NESS ZIONA, Israel, April 15, 2026 (GLOBE NEWSWIRE) -- Orvida Pharma (formerly Kamari Pharma), a privately held clinical-stage biotechnology company developing first and best-in-class treatments for rare and severe genetic skin diseases, today announced favorable safety results from the Phase 1a portion of its Phase 1a/1b clinical trial evaluating KM-023, a potential first-in-class oral TRPV3 inhibitor. The company has also initiated the Phase 1b portion of the study in patients with Olmsted syndrome, and the first patient has been dosed.
“The favorable safety profile observed in Phase 1a represents an important milestone for KM-023 and supports advancing the program in patients,” said Dr. David Aviezer, Chief Executive Officer of Orvida Pharma. “Olmsted syndrome is a rare and devastating genetic skin disorder that causes extremely painful, thickened skin on the palms and soles. The condition can severely limit mobility and everyday life. With no approved therapies available today, patients face a profound unmet medical need. We believe KM-023 has the potential to become the first targeted treatment for this condition as well as for other rare genetic skin disorders, and we are committed to advancing its development with urgency for patients and families who need new options.”
The Phase 1a portion of the trial was a randomized, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of KM-023 in 30 healthy volunteers in France. The study included both single-ascending dose (SAD) and multiple-ascending dose (MAD) cohorts. Eighteen participants received at least one oral dose ranging from 15 mg to 50 mg across three SAD cohorts, and 12 participants received repeated twice-daily (BID) oral doses of 15 mg to 35 mg for up to five days in the MAD cohorts. The study also evaluated how KM-023 is absorbed and processed by the body, including drug levels in the blood and skin, and the effect of food on KM-023 pharmacokinetics.
In Phase 1a, KM-023 demonstrated a favorable safety profile, with no treatment-related adverse events (TRAEs) reported in the SAD cohorts. Two mild, isolated TRAEs were observed in the MAD cohorts, one in the 15 mg BID cohort and one in the 35 mg BID cohort. Both TRAEs were transient and did not require intervention. No dose interruptions or discontinuations due to adverse events occurred.
The Phase 1b portion of the trial is a global study evaluating KM-023 in patients with Olmsted syndrome at clinical sites in the United Kingdom, the U.S., and Europe. The study is designed to assess the safety, tolerability, pharmacokinetics, and exploratory signs of clinical activity of KM-023 in patients. Participants will receive KM-023 twice daily for 12 weeks, with regular clinical visits to monitor safety, drug exposure, and potential effects on disease symptoms. Drug levels in the blood and skin will also be evaluated to better understand how KM-023 is distributed and acts in affected tissue. The trial is being conducted under protocols approved by the U.S. Food and Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and the French Regulatory Agency (ANSM). Additional information is available at ClinicalTrials.gov (NCT07090889).
The first patient with Olmsted syndrome has been dosed in the Phase 1b study, and topline results are expected in the third quarter of 2026.
“Olmsted syndrome has profound effects on skin function and patient quality of life,” said Prof. Edel O’Toole, MD, PhD, FRCP, of Queen Mary University of London, a leading dermatologist and investigator in the KM-023 Olmsted syndrome clinical program. “TRPV3 plays a key role in the underlying disease biology, and targeting this pathway with KM-023 represents a compelling therapeutic approach. These early safety data are encouraging and support the continued evaluation of KM-023 in patients with Olmsted syndrome.”
About Orvida Pharma
Orvida Pharma (formerly Kamari Pharma) is a clinical-stage biotechnology company developing first- and best-in-class treatments for rare and severe genetic skin diseases. The Company’s lead molecule, KM-023, is a novel, highly specific, and selective oral TRPV3 inhibitor initially being developed for the treatment of Olmsted syndrome and severe keratodermas. Orvida’s management team comprises industry leaders with deep expertise in drug discovery, dermatological pharmaceutical development, and rare disease therapeutics.
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