Levo Therapeutics has announced that the FDA has granted Fast Track designation to its LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS). In December 2018, Levo said that it was initiating the CARE-PWS Phase 3 study of LV-101 for PWS; the company says that the study is currently enrolling participants.
The company also said that it has completed a Series B financing round. Funds will go toward the CARE-PWS trial, for other LV-101 development costs, and for other pipeline programs.
Levo Therapeutics CEO Sara Cotter commented, “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.”
Read the Levo Therapeutics press release.
