Levo Therapeutics Announces Initiation of the CARE-PWS Phase 3 Study of Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome
CHICAGO, Dec. 12, 2018 /PRNewswire/ -- Levo Therapeutics, Inc. announced today that enrollment is underway in its Phase 3 clinical study of intranasal carbetocin (LV-101) for the treatment of Prader-Willi syndrome (PWS). The study is a multi-center, randomized, double-blind, placebo-controlled study called CARE-PWS.
"We are excited to bring intranasal carbetocin back into the clinic following the successful Phase 2 study," said Sara Cotter, CEO of Levo Therapeutics. "Levo is committed to developing impactful treatments for patients with PWS, and our initiation of this Phase 3 study is an important step towards this goal."
"Hyperphagia, obsessive and compulsive symptoms, and anxiety are debilitating symptoms of the syndrome," said Jennifer Miller, MD, of the University of Florida, Gainesville. "We are excited to participate in the CARE-PWS study, which aims to treat these symptoms."
"After participating in the positive Phase 2 study of intranasal carbetocin, we have been eager to help advance this program as a Phase 3 clinical site," said Elizabeth Roof of Vanderbilt University. The Phase 2 study was conducted at three clinical sites in the United States: Vanderbilt University, the University of Florida, and NYU Winthrop Hospital.
The Phase 3 CARE-PWS study is currently enrolling study participants at both University of Florida and Vanderbilt University, and Levo anticipates additional study sites opening soon. Listings of clinical study sites for the CARE-PWS study will be kept updated on clinicaltrials.gov (study NCT03649477) and at www.levotx.com/care-pws.
About CARE-PWS (CARbetocin Efficacy and Safety Study in PWS)
This multi-center, randomized, double-blind, placebo-controlled study has an 8-week period designed to test the effectiveness, safety, and tolerability of LV-101 in participants with PWS.
Effectiveness will be measured using both caregiver-reported and clinician-reported measures of hyperphagia (extreme hunger), obsessive and compulsive behaviors, and anxiety. Safety and tolerability will be measured by adverse events, laboratory tests, and physical exams.
All participants will receive active treatment with LV-101 after the 8-week placebo-controlled period, during a long-term follow-up period of 56 weeks. At Week 8, participants who were randomized to placebo in the placebo-controlled period will be randomized to one of the two LV-101 doses, administered three times per day before meals.
About Intranasal Carbetocin
Carbetocin is an analog of the naturally-occurring neuroendocrine hormone oxytocin. Carbetocin was designed to have an improved receptor binding profile compared to oxytocin, with greater affinity for the oxytocin receptor and lower affinity for related vasopressin receptors. It is approved in over 90 countries outside the United States for the prevention of uterine atony and excessive bleeding during cesarean section delivery, with an estimated cumulative exposure of over 10 million patients. LV-101 is an investigational intranasal form of carbetocin, intended to be administered to patients with PWS three times each day before meals.
About Prader-Willi Syndrome (PWS)
Prader-Willi syndrome (PWS) is a complex, multisystem neurodevelopmental disorder that occurs in approximately 1 in 16,000 births1. The underlying cause of PWS is the lack of expression of paternally-inherited imprinted genes on chromosome 15q11-q13. These genetic anomalies lead to a distinctive phenotype that includes mild to moderate levels of intellectual disability, compulsivity, growth hormone deficiency, life-threatening hyperphagia, and high risk of obesity.
About Levo Therapeutics, Inc.
Levo Therapeutics is a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome and related disorders. To learn more about Levo, please visit www.levotx.com.
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Levo Therapeutics, Inc.
1Burd L, Vesely B, Martsolf J, Kerbeshian J. Prevalence study of Prader-Willi syndrome in North Dakota. Am J Med Genet. 1990; 37:97-9.