Palvella Therapeutics, Inc. (Palvella), has announced that the United States Patent and Trademark Office (USPTO) issued patent No. 12,329,748 for claims related to the company's lead product candidate QTORIN 3.9 percent rapamycin anhydrous gel (QTORIN rapamycin). The patent provides broad protection for the proprietary anhydrous topical composition and methods of use for QTORIN rapamycin.

Palvella is a clinical-stage biopharmaceutical company focused on developing and commercialising novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no US Food and Drug Administration (FDA)-approved therapies.

Commenting on the development, Wes Kaupinen, Founder and Chief Executive Officer of Palvella said, “Our sixth issued US patent marks another meaningful milestone in solidifying the exclusivity position of QTORIN rapamycin. We’re executing a multi-layered strategy to protect and maximise the long-term value of QTORIN rapamycin—anchored by strong intellectual property, proprietary formulation and manufacturing trade secrets, and regulatory exclusivities.”

The newly granted US patent encompasses a wide range of composition and method-of-use claims for QTORIN rapamycin and other mTOR inhibitors—including temsirolimus and everolimus—formulated in anhydrous compositions. It also covers treatment of a broad spectrum of dermatologic conditions, with emphasis on rare and difficult-to-treat diseases such as microcystic lymphatic malformations and venous malformations.

QTORIN rapamycin has been granted Breakthrough Therapy, Orphan Drug, and Fast Track Designations by the FDA for the treatment of microcystic lymphatic malformations. If approved, QTORIN rapamycin is expected to qualify for seven years of orphan drug market exclusivity in the US.

Palvella has also been named an awardee of an FDA Orphan Products Grant from the FDA’s Office of Orphan Products Development and is eligible to receive up to USD 2.6 million over the life of the grant to support the ongoing SELVA Phase 3 trial of QTORIN rapamycin.