Levo Therapeutics announced top-line results from the Phase 3 CARE-PWS clinical study evaluating LV-101 (intranasal carbetocin) for the treatment of Prader-Willi Syndrome (PWS). CARE-PWS tested two doses of LV-101 versus placebo. Following the FDA’s discussion, enrollment in the trial was closed early due to COVID-19, with 119 evaluable patients in the Primary Analysis Set. While the primary endpoint was not reached, a key secondary endpoint was achieved.
CARE-PWS was a multi-center, randomized, double-blind, 8-week placebo-controlled study designed to test the effectiveness, safety, and tolerability of LV-101 (intranasal carbetocin) in participants age 7-18 with PWS. Effectiveness was measured using both caregiver-reported and clinician-reported measures of hyperphagia (extreme hunger), obsessive and compulsive behaviors, and anxiety. The trial tested two doses of LV-101 versus placebo with 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.
As stated, the study did not meet its primary outcome measurements, evaluating the 9.6 mg dose of LV-101 (intranasal carbetocin)....
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