WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) announced the development of QTORIN™ pitavastatin, a novel investigational therapy for disseminated superficial actinic porokeratosis (DSAP), a rare and progressive skin disease with no FDA-approved treatments. The company plans to initiate a Phase 2 clinical trial for the candidate in the second half of 2026.
Developed using Palvella’s proprietary QTORIN™ platform, the new therapy is designed to deliver pitavastatin directly to diseased skin tissue, targeting the root cause of DSAP by inhibiting the mevalonate pathway—a genetic driver of the disease. The condition affects more than 50,000 diagnosed patients in the United States, producing numerous expanding lesions that can lead to chronic skin damage and, in some cases, progress to squamous cell carcinoma.
“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,” said Wes Kaupinen, founder and chief executive officer of Palvella Therapeutics. “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.”
Kaupinen noted that pitavastatin’s potency and precision make it particularly well suited for Palvella’s QTORIN™ technology, which is engineered to reproducibly generate topical formulations targeting rare dermatologic diseases.
Palvella intends to meet with the U.S. Food and Drug Administration in the first half of 2026 to finalize the design of the upcoming Phase 2 clinical study. The company’s long-term goal is to establish QTORIN™ pitavastatin as the first approved, pathogenesis-directed treatment for DSAP, potentially transforming care for patients with this debilitating and often overlooked condition.
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