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Debiopharm Announces First Patient Enrolled in Phase III Study
News

Debiopharm Announces First Patient Enrolled in Phase III Study

Debiopharm Announces First Patient Enrolled in Phase III Study
News

Debiopharm Announces First Patient Enrolled in Phase III Study

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Debiopharm Group™ has 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-randomized 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.

Mauvernay continued, “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”.

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