Orvida Pharma Accepts FDA RDEP for Olmsted Syndrome Treatment

NESS ZIONA, Israel, Oct. 14, 2026 /CourierPR/ -- 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. This acceptance represents an important regulatory milestone for Orvida and the development of ontivatrep for Olmsted syndrome. The RDEP process aims to provide greater speed and predictability in the review of therapies for rare diseases with significant unmet medical need.

The FDA’s Rare Disease Evidence Principles (RDEP) process is designed to offer greater clarity and predictability regarding the types of evidence that can be used to demonstrate substantial evidence of effectiveness for eligible rare diseases. Accepted sponsors meet with the appropriate FDA review team to determine the data needed to substantiate safety and effectiveness. Depending on the circumstances, this may include one adequate and well-controlled study together with robust confirmatory evidence, which may include mechanistic or biomarker evidence, findings from relevant nonclinical models, clinical pharmacodynamic data, case reports, expanded access data, or natural history studies.

Orvida Pharma’s lead investigational candidate, ontivatrep, is a highly specific and selective oral TRPV3 inhibitor being developed for Olmsted syndrome, severe keratodermas, and ichthyosis. Olmsted syndrome is a rare and severe genetic skin disorder characterized by painful, thickened skin, particularly on the palms and soles, which can significantly impair mobility and quality of life and, in some cases, can be life-threatening. 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. Topline results are expected around year-end 2026.

Orvida will deliver a corporate presentation during BIO-Europe 2026, taking place November 9-11 in Cologne, Germany, and participate in the Jefferies Global Healthcare Conference in London, November 16-19. The Company will be available for one-on-one meetings with investors and pharmaceutical companies at both conferences.

The International Nonproprietary Name (INN) and United States Adopted Name (USAN) for ontivatrep are pending.