Press Release

PRESS RELEASE FIRST PATIENTS DOSED IN DEBIOPHARM’S PHASE III TRIAL (LIBELULA) INVESTIGATING DEBIO 4326, A 12-MONTH TRIPTORELIN FORMULATION FOR CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY Debiopharm’s expertise in extended-release formulations could lighten the burden of treatment for children with Central Precocious Puberty (CPP) and their families by reducing injection frequency to once a year [...] 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). [...] “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. [...] “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 caretakers by 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. [...] CPP is triggered by the early release of the gonadotropin-releasing hormone in the brain and premature activation of the hypothalamic-pituitary- gonadal axis. This early activation can be due to specific genetic alterations, central nervous system lesions, and social stressors but frequently has no identified etiology [3]. [...] Since the early 1980s, Gonadotropin-Releasing Hormone agonists (GnRHa) such as triptorelin have been the standard ofcare for the treatment of CPP [14-16]. [...] About Debio 4326 Debio 4326 is a unique injectable, biodegradable 12-month extended-release formulation of triptorelin designed to further reduce the frequency of injections and burden of administrations, particularly considering its intended use in a pediatric population.