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

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

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)....

Note:  If you need assistance with your subscription or would like to discuss a corporate subscription for more than 10 employees please contact us or use the chat (bottom right).

Personal
$5 / Month
Individuals at home that are reading our content for personal health care or other non-professional reasons.
Like a Starbucks a month
Personal - Single Payment
$50 for 1 Year
Individuals - reading for personal reasons who prefer to pay for one year in advance with no recurring billing.
18% discount to monthly
Professional
$12 / Month
Professionals from the healthcare industry who are subscribing on behalf of their company for work reasons.
Way better than coffee