Levo Therapeutics Announces Top-line Results from Phase 3 CARE-PWS Study of LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome

CHICAGO–(BUSINESS WIRE)–Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today top-line results from the Phase 3 CARE-PWS clinical study evaluating LV-101 (intranasal carbetocin) for the treatment of PWS. This syndrome is a complex, neurodevelopmental disorder that occurs in approximately 1 in 16,000 birthsi and is characterized by a false state of starvation and associated hyperphagia (unrelenting hunger), to which a deficiency in oxytocin is believed to be contributoryii. LV-101 is a selective oxytocin-receptor agonist. CARE-PWS tested two doses of LV-101 versus placebo with an even randomization (1:1:1), specifying the 9.6 mg dose as the primary endpoint and the 3.2 mg dose as the first secondary endpoint. After consultation with the U.S. Food and Drug Administration (FDA), enrollment was closed early due to COVID-19 with 119 evaluable patients in the Primary Analysis Setiii.

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