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Levo Product Joins List Of Prader-Willi Syndrome Trial Failures

But Company Confident About Lower Dose Of Intranasal Carbetocin

 
• By Kevin Grogan

Attempts at developing an effective therapy for PWS, and the abnormal desire for food associated with the rare disorder, have been fruitless but Levo Therapeutics' enthusiasm for LV-101 remains high, despite a Phase III setback.

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Children With PWS struggle to maintain a healthy weight • Source: Shutterstock

Levo Therapeutics, Inc. is the latest company to come up short in developing a drug for Prader-Willi Syndrome (PWS), a rare neurodevelopmental disorder that can cause a wide range of physical symptoms, learning difficulties and behavioural problems.

The US biotech has announced top-line results from the Phase III CARE-PWS clinical study evaluating LV-101 (intranasal carbetocin) for the syndrome which show that a 9.6mg dose failed to show a significant improvement in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score, the primary endpoint of the trial, compared with placebo at week 8

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