Palvella Therapeutics Reports Positive Phase 2 Results For QTORIN Rapamycin Gel

Palvella Therapeutics

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(RTTNews) - Palvella Therapeutics, Inc. (PVLA) on Monday announced positive topline results from its Phase 2 TOIVA study of QTORIN 3.9% rapamycin anhydrous gel for the treatment of cutaneous venous malformations. Cutaneous venous malformations are congenital, chronic, progressive lesions that persist throughout life.

In the study, QTORIN rapamycin was administered topically once daily for 12 weeks, followed by a 12-week extension period. At Week 12, 73% of participants showed improvement on the Overall Cutaneous Venous Malformations Investigator Global Assessment (cVM-IGA), while 67% of patients were rated as Much Improved or Very Much Improved.

The company said the study achieved statistical significance across multiple efficacy endpoints, including both dynamic change and static severity measures. QTORIN rapamycin was generally well tolerated, with no drug-related serious adverse events reported.

Based on the Phase 2 results, Palvella plans to initiate near-term discussions with the U.S. Food and Drug Administration regarding a potential Breakthrough Therapy Designation and a Phase 3 pivotal study. The FDA has previously granted Fast Track Designation to QTORIN rapamycin for venous malformations.

Palvella Therapeutics shares rose more than 3% in pre-market trading, after closing at $98.58, up 1.86% on Friday.