Palvella Therapeutics Completes Enrollment in Phase 2 TOIVA Trial of QTORIN™ Rapamycin for Cutaneous Venous Malformations

Core Insights - The Phase 2 TOIVA trial of QTORIN™ rapamycin has successfully met its recruitment target, enrolling 16 subjects, with top-line data expected in mid-December 2025 [1][3] - Cutaneous venous malformations (VMs) are a significant unmet medical need, affecting quality of life and lacking FDA-approved therapies [2][3] - QTORIN™ rapamycin is positioned to potentially be the first approved therapy for over 75,000 U.S. patients with cutaneous VMs [1][3] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare genetic skin diseases without FDA-approved treatments [4] - The company is led by veterans in rare disease drug development and is advancing a pipeline based on its patented QTORIN™ platform [4] - QTORIN™ rapamycin is currently being evaluated in both the Phase 2 TOIVA trial for cutaneous VMs and the Phase 3 SELVA trial for microcystic lymphatic malformations [4] Clinical Trial Details - The TOIVA trial is a single-arm, open-label, baseline-controlled study assessing the safety and efficacy of QTORIN™ rapamycin, which is administered topically once daily [2] - The trial aims to evaluate safety through adverse event incidence and severity, alongside multiple efficacy measures [2] - Insights from the TOIVA trial are expected to inform future clinical trial designs for Palvella's product candidates [3]