First Patients Dosed in Debiopharm's Phase III Trial of a 12-Month Triptorelin Formulation for Children with Central Precocious Puberty

Published on

A nurse preps a patient arm for an injection

Debiopharm, a privately-owned, Swiss-based biopharmaceutical company aiming to develop innovative therapies and to improve patient quality of life. On 9 September, they announced the dosing of the first sentinel patients in its open-label, single-arm, multi-center Phase III study, NCT06129539 ‘A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty (LIBELULA)’.

Triptorelin is an established treatment for CPP as a 1-, 3- and 6-month formulation. This new phase III study evaluating the novel 12-month triptorelin formulation is being carried out in North and South America.

In pursuit of developing safe, effective, and convenient treatment options for patients, Debiopharm, is applying its expertise in extended-release formulations to achieve the first yearly injectable Gonadotropin-Releasing Hormone agonist (GnRHa). Reducing treatment burden while preserving triptorelin’s well-known efficacy and safety are key elements that Debiopharm is eager to assess through this study.

“It is always disheartening to see such young children burdened by the effects of central precocious puberty and the lifelong complications it may cause. We are thankful that treatments like triptorelin are already on the market, and that companies like Debiopharm continue to invest in lightening the patient care burden with formulations that reduce injection frequency,” expressed Prof. Fernando Cassorla, Principal Investigator, Pediatrics Department at the Hospital San Borja Arriarán in Santiago, Chile.

“As patients are at the center of all we do, we recognize that convenience matters. Reducing injection frequency to once a year can lower the burden for CPP patients and their caretakersby reducing children’s stress and improving overall compliance. We are enthusiastic about the first patients enrolled in this phase III trial that can bring both medical and practical advancements,” expressed Bertrand Ducrey, CEO of Debiopharm.

For more information, read the original press release.

For more news from the world of long-acting therapeutics, sign up to the CELT's LONGEVITY mailing list here for regular updates.