Palvella Therapeutics Inc. (PVLA), Tuesday announced the issuance of a new U.S. patent covering its lead product candidate, QTORIN 3.9 percent rapamycin anhydrous gel, for the treatment of microcystic lymphatic malformations (microcystic LMs)—a serious and rare genetic skin condition.
The newly issued U.S. Patent No. 12,268,673, titled "Anhydrous Compositions of mTOR Inhibitors and Methods of Use," marks the fifth U.S. patent granted for QTORIN rapamycin and extends intellectual property protection through at least 2038.
Palvella noted that QTORIN rapamycin may become the first FDA-approved treatment and standard of care for microcystic LMs in the U.S., a condition affecting over 30,000 diagnosed patients with no currently approved therapies.
"This fifth U.S. patent reflects the significant innovation behind QTORIN™ rapamycin and our platform technology," said Wes Kaupinen, Founder and CEO of Palvella. "It reinforces our commitment to delivering the first targeted therapy for this debilitating disease."
QTORIN rapamycin has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA for microcystic LMs. If approved, it will also qualify for seven years of orphan drug market exclusivity in the U.S.
Microcystic LMs are caused by dysregulation of the PI3K/mTOR pathway, leading to malformed, leaking lymphatic vessels that cause recurrent infections, bleeding, and long-term complications. The condition is progressive and lifelong.
QTORIN rapamycin is currently being evaluated in the Phase 3 SELVA trial for microcystic LMs and in the Phase 2 TOIVA trial for cutaneous venous malformations.
Palvella emphasized that the patent award strengthens its growing intellectual property portfolio and supports its broader pipeline of investigational treatments for rare genetic skin diseases.
Currently, PVLA is trading at $25.68 up by 0.91 percent on the Nasdaq.
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