Pieris Pharmaceuticals' (PIRS) merger target Palvella Therapeutics dosed the first patient in the phase 3 trial of QTORIN 3.9% rapamycin anhydrous gel, a treatment for microcystic lymphatic malformations.
Microcystic LMs is a rare genetic disease where abnormal lymph vessels leak fluid and bleed, causing frequent infections and skin problems.
The main goal of the study is to measure the change in the severity of microcystic LMs after 24 weeks, Palvella said Thursday in a statement. The trial will involve about 40 participants ages 6 and older, the company said.
The gel has received the US Food and Drug Administration's breakthrough therapy, fast track and orphan drug designations, and Palvella got up to $2.6 million from the agency to support the study.
Palvella and Pieris Pharmaceuticals agreed in July to merge.
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