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Palvella Therapeutics to Expand Phase 3 SELVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations to Include the Younger Pediatric Population, Children 3 to 5 Years Old
Expansion reflects Palvella's commitment to serving all patients affected by microcystic lymphatic malformations (microcystic LMs) Company remains on track to
About this update from Palvella Therapeutics, Inc.
[{"type":"text","content":"Expansion reflects Palvella's commitment to serving all patients affected by microcystic lymphatic malformations (microcystic LMs) Company remains on track to report top line results from SELVA, a Phase 3 single-arm, baseline-controlled trial evaluating QTORIN™ rapamycin for the treatment of microcystic LMs, in Q1 2026 QTORIN™ rapamycin has the potential to be the first approved therapy and standard of care in the U.S. for microcystic LMs WAYNE, Pa., Feb. 10, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, today announced that it will expand SELVA, the Company's Phase 3 clinical trial of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs), to include patients ages 3 to 5 years old. Previously, trial participants were required to be at least 6 years old. This decision follows communication with the U.S. Food and Drug Administration (FDA) in which the agency deemed the Company's proposed expansion acceptable. “Microcystic LMs is a debilitating disease that is chronic, progressive, and usually present at birth or shortly after. Patients with microcystic LMs often have lymphorrhea, bleeding, infection, pain, and disfigurement which may lead to difficulty with physical activities as well as more significant complications like cellulitis and hospitalization,” said Joyce Teng MD, PhD, Professor of Dermatology and Pediatrics at Stanford University and Principal Investigator of the SELVA Study. “Early intervention is essential to minimize disease burden during children’s development which is why I am so excited by the opportunity QTORIN rapamycin presents to the younger pediatric population.” Palvella is currently enrolling approximately 40 patients in SELVA, a 24-week, Phase 3, single-arm, baseline-controlled trial of QTORIN™ rapamycin for the treatment of microcystic LMs. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation to QTORIN™ rapamycin for the treatment of microcystic LMs. Additionally, the SELVA study is supported b...