Palvella Therapeutics (NASDAQ: PVLA) announced that Clinical and Experimental Dermatology has published a peer-reviewed systematic review synthesizing clinical evidence on off-label topical statin use in porokeratosis, supporting the scientific rationale and clinical potential of its QTORIN pitavastatin for treating disseminated superficial actinic porokeratosis (DSAP).
QTORIN is anticipated to enter Phase 2 development in the second half of 2026.
In a statement, Maria Gnarra Buethe, MD, PhD, FAAD, pediatric dermatology director at the University of California, Irvine, and division chief of Dermatology at Rady Children’s Hospital of Orange County, commented, “Porokeratosis is a serious, progressive genetic skin disease that carries a meaningful risk of malignant transformation, particularly in patients with DSAP. Advances in our understanding of porokeratosis have identified mutations in the mevalonate pathway as central drivers of disease pathogenesis. While systemic statins have not demonstrated clinical benefit—likely due to limited skin bioavailability—this systematic review underscores the mechanistic rationale and emerging clinical evidence supporting topical application of statins in porokeratosis as a potential targeted therapeutic approach for a condition with no FDA-approved treatments.”
Jeff Martini, PhD, CSO of Palvella, remarked, “There is a significant unmet need in porokeratosis, with no FDA-approved therapies and a high burden of disease characterized by numerous expanding lesions that do not spontaneously regress, which significantly impact quality-of-life. This systematic review highlights a potentially important role for QTORIN pitavastatin in porokeratosis. It also further validates Palvella’s approach to addressing DSAP, the most common subtype of the disease, which affects an estimated more than 50,000 diagnosed patients in the U.S., with QTORIN pitavastatin, if approved.”
