Debiopharm initiates enrollment in triptorelin phase III study for central precocious puberty

Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced that the first patient has been enrolled in an open-label phase III study to investigate the efficacy, safety, and pharmacokinetics of the sustained release triptorelin pamoate 22.5 mg 6-month-formulation in children with central precocious puberty (CPP), a rare disease.

The multicentre, open-label, non-randomised study will involve 44 children from the United States, Chile and Mexico. Its primary objective is to evaluate the efficacy and safety of triptorelin pamoate (embonate) 22.5 mg 6-month formulation in decreasing luteinizing hormone (LH) to prepubertal levels at Month 6 (Day 169) in children with CPP.

"We are excited to be part of this study, which is the first Debiopharm-sponsored clinical trial using triptorelin for the treatment of CPP," said Rolland-Yves Mauvernay, President and founder of Debiopharm Group. "Our aim is to show that a gonadotropin-releasing hormone (GnRH) agonist therapy prevents the social and psychological difficulties associated with premature sexual development, and has a positive impact on compromised adult height. The 6-month-formulation would entail an improved compliance in a paediatric indication for which no other 6-month GnRH agonist formulation is currently approved, whilst reducing the frequency of injections in children."