WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) announced it will expand development of its investigational therapy QTORIN™ 3.9% rapamycin anhydrous gel into clinically significant angiokeratomas, a rare and debilitating vascular skin disease with no FDA-approved treatments.
“Based on scientific discoveries further characterizing the biology of angiokeratomas as well as published case studies on the use of off-label rapamycin, we’re excited to expand the development of QTORIN™ rapamycin into this rare, chronically debilitating disease,” said Wes Kaupinen, founder and CEO of Palvella. “Clinically significant angiokeratomas represent our third target clinical indication for QTORIN™ rapamycin and align with Palvella’s strategy of selecting serious, rare skin diseases in which Palvella has the opportunity to introduce the first FDA-approved therapy.”
Clinically significant angiokeratomas, recently classified by the International Society for the Study of Vascular Anomalies as isolated lymphatic malformations, can cause bleeding, pain, functional impairment, and infections, often requiring invasive procedures with risks of scarring and recurrence.
Palvella plans to meet with the FDA in the first half of 2026 to finalize the design of a Phase 2 trial enrolling 10–20 patients, with study initiation expected later that year. The company is also advancing QTORIN™ rapamycin in other rare vascular conditions, including microcystic lymphatic malformations in its Phase 3 SELVA trial and cutaneous venous malformations in its Phase 2 TOIVA trial, with top-line data expected in 2026 and December 2025, respectively.
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