Levo gets FDA fast track status for LV-101 in Prader-Willi syndrome

US biotech company Levo Therapeutics has been granted fast track designation for LV-101 (intranasal carbetocin) from the US Food and Drug Administration (FDA) for the treatment of Prader-Willi syndrome (PWS).

According to the US National Library of Medicine, Prader-Willi syndrome is a complex genetic condition that impacts several parts of the body. In infancy, Prader-Willi syndrome is characterized by weak muscle tone, poor growth, feeding difficulties, and delayed development.

Currently, Levo Therapeutics is engaged in the enrollment of participants for a phase 3 clinical study of intranasal carbetocin for the treatment of Prader-Willi syndrome. The late-stage trial called CARE-PWS will be held at more than 20 centers in the US and Canada and is going to be a randomized, double-blind, placebo-controlled study.

The US biotech company expects to open more study sites for the CARE-PWS clinical trial in Australia shortly.

Levo Therapeutics gets FDA fast track status for LV-101 in Prader-Willi syndrome. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

Sara Cotter – CEO of Levo Therapeutics said: “We are thrilled to receive Fast Track designation from the FDA, which supports the understanding among the PWS community that this syndrome presents serious and life-threatening issues.

“Levo is committed to developing impactful treatments for patients with PWS, and our Phase 3 study is designed to see whether intranasal carbetocin provides one such treatment. We look forward to finishing enrollment of this important clinical study in the coming months.”

Levo Therapeutics also announced the closing of a Series B financing round, that was co-led by Samsara BioCapital and an unnamed healthcare investment fund. The biotech company intends to use the proceeds from the financing to support the CARE-PWS trial and also to advance its pipeline programs.