Palvella Therapeutics, a clinical-stage biopharmaceutical company focused on developing treatments for rare, serious skin diseases with no FDA-approved therapies, has announced a new product candidate, QTORIN™ pitavastatin, for treating disseminated superficial actinic porokeratosis (DSAP). The product was developed using Palvella's patented QTORIN™ platform, which creates novel, topical treatments for rare skin conditions.
DSAP is a genetic skin condition caused by mutations in the mevalonate pathway, leading to the buildup of harmful intermediates. It causes persistent lesions that grow in size, number, and spread over time, damaging the skin and significantly affecting quality of life. DSAP is considered premalignant, with a risk of developing into squamous cell carcinoma, especially in long-term or widespread cases. Spontaneous regression is rare, and there are currently no FDA-approved treatments for the estimated 50,000+ patients in the United States.
Palvella plans to meet with the FDA in the first half of 2026 to discuss the design of a Phase 2 clinical trial for QTORIN™ pitavastatin in patients with disseminated superficial actinic porokeratosis. The trial is expected to begin in the second half of 2026.
Executive Statement
According to Wes Kaupinen, Founder and Chief Executive Officer, QTORIN™ pitavastatin has the potential to be the first pathogenesis-directed therapy for the treatment of DSAP, a serious, rare skin disease which currently has no FDA-approved therapies. Recent breakthrough scientific discoveries further characterizing the genetics and biology of DSAP, as well as published case studies on the use of off-label topical statins, provide strong scientific rationale for advancing the development of QTORIN™ pitavastatin. With its superior potency relative to other mevalonate pathway inhibitors, pitavastatin represents a next-generation statin ideally suited for QTORIN™ development in DSAP.