Levo Therapeutics has started patient enrolment in its Phase III CARE-PWS clinical study to evaluate the effectiveness of intranasal carbetocin (LV-101) for the treatment of Prader-Willi syndrome (PWS).

PWS is a complex, multisystem neurodevelopmental disorder that affects nearly one in 16,000 births.

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The CARE-PWS trial follows the successful completion of a Phase II study of intranasal carbetocin and is currently enrolling subjects at the University of Florida and Vanderbilt University in the US.

Levo aims to enrol 175 subjects for the multi-centre, randomised, double-blind trial.

“Hyperphagia, obsessive and compulsive symptoms, and anxiety are debilitating symptoms of the syndrome.”

Subjects will receive intranasal carbetocin after completing the eight-week placebo-controlled phase.

At week eight, subjects who received placebo will be randomised to receive one of the two doses of intranasal carbetocin three times a day before meals.

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The trial intends to assess the effectiveness of LV-101 using both caregiver-reported and clinician-reported measures of hyperphagia (extreme hunger), obsessive and compulsive behaviors, as well as anxiety.

It also aims to measure safety and tolerability using adverse events, laboratory tests, and physical exams.

The trial will feature a long-term follow-up period of 56 weeks.

University of Florida Gainesville MD Jennifer Miller said: “Hyperphagia, obsessive and compulsive symptoms, and anxiety are debilitating symptoms of the syndrome.”

Levo’s intranasal carbetocin is an analogue of neuroendocrine hormone oxytocin and is developed to have an improved receptor binding profile compared to oxytocin.