Palvella Therapeutics Inc. (PVLA), a clinical-stage biopharmaceutical company, announced on Monday the dosing of the first patient in the Phase 2 LOTU trial for the QTORIN 3.9% rapamycin anhydrous gel in treating angiokeratomas.
Angiokeratomas are isolated lymphatic malformations, presenting as hyperkeratotic vascular lesions. Rare, chronic, and debilitating, the disease is often burdensome to patients, with treatments being largely invasive and incomplete in controlling the disease. There are no therapies for angiokeratomas currently approved by the U.S. food and drug administration (FDA).
The QTORIN 3.9% rapamycin anhydrous gel is the lead product candidate of Palvella, and acts by inhibiting the mammalian targeting of rapamycin (mTOR). The drug was previously granted fast track designation by the FDA.
The Phase 2 LOTU trial is a single-arm, baseline-controlled study to determine the safety and efficacy of QTORIN 3.9% rapamycin anhydrous gel in treating angiokeratomas, when applied topically, once daily, across 12 weeks.
The proof-of-concept study plans to dose up to 15 subjects, with topline results expected by the second half of 2027.
PVLA closed Friday at $126.84, down 1.15%.
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