WAYNE, PA — Palvella Therapeutics (Nasdaq: PVLA) has secured a new U.S. patent covering a key treatment approach for porokeratosis, strengthening its intellectual property position as the company prepares to advance an experimental therapy into mid-stage clinical testing for a rare skin disorder with no approved treatments.
The company said the U.S. Patent and Trademark Office issued Patent No. 12,636,273, which is exclusively licensed from Yale University and supports development of QTORIN pitavastatin, a topical therapy being studied for porokeratosis, including disseminated superficial actinic porokeratosis (DSAP).
The patent covers the use of topical HMG-CoA reductase inhibitors, including pitavastatin, for treating porokeratosis and provides protection through 2043, according to the company.
The intellectual property milestone comes as Palvella plans to launch a Phase 2 clinical trial of QTORIN pitavastatin in DSAP during the second half of 2026.
DSAP is a rare inherited skin disease characterized by abnormal skin lesions and is considered premalignant because affected tissue can develop into skin cancer. Palvella estimates that more than 50,000 diagnosed patients in the United States are living with the condition, and no therapies have received approval from the U.S. Food and Drug Administration.
The patent is based on research conducted by Keith Choate, chair of dermatology, pathology, and genetics at Yale School of Medicine, whose work helped identify the role of the mevalonate pathway in porokeratosis.
Palvella said it has also filed a separate patent application covering its proprietary formulation of pitavastatin and related methods of use.
The company is developing QTORIN pitavastatin as a targeted topical therapy designed to inhibit the mevalonate pathway directly within affected skin tissue. If successful in clinical testing, the treatment could become one of the first therapies specifically developed for DSAP.
The patent issuance expands Palvella’s intellectual property portfolio at a critical stage as the biotechnology company advances its pipeline of treatments for rare dermatological diseases that currently lack FDA-approved therapeutic options.
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