Debiopharm, a privately-owned Swiss biopharmaceutical company focused on oncology and rare diseases, has announced that the first patient has been randomized in the OXTEND-03 Phase III clinical trial. 

The study will evaluate Debio 4126, a novel long-acting octreotide formulation and the first potential three-month somatostatin analogue (SSA), in adults with acromegaly currently maintained on SSAs. 

Spanning approximately 75 sites across 21 countries, OXTEND-03 aims to enroll around 120 patients. The trial’s primary goal is to confirm that Debio 4126 can maintain biochemical control of acromegaly while reducing the annual injection burden from 12 to just 4, improving convenience, adherence, and potentially easing healthcare resource use. 

“The dosing of the first patient in OXTEND-03 is a monumental achievement for our team and confirms our commitment to addressing high unmet needs in rare diseases,” said Yanina Negievich, Medical Director for the Debio 4126 Program at Debiopharm. 

“Our goal with Debio 4126 is to empower patients by reducing the complexity of their treatment. Moving from monthly to quarterly injections could make a real difference, helping patients focus on living rather than managing their condition.” 

“Acromegaly management can be highly demanding due to the required monthly injections in many patients, which impose a significant physical and emotional burden. A quarterly treatment regimen could be a game-changer for both patients and healthcare professionals. 

"The OXTEND-03 trial is essential for validating Debio 4126 as a new, less burdensome option that maintains control, potentially leading to better patient adherence and overall well-being,” said Maria Fleseriu, professor and director of pituitary center, global principal investigator. 

Acromegaly's current treatments require lifelong monthly injections, which are associated with injection site reactions in up to 77% of patients and persistent symptoms that impact quality of life. Debio 4126 offers the promise of sustained biochemical control with a quarterly dosing schedule, addressing a critical unmet need. 

Debio 4126 is designed for intramuscular administration every three months. Early clinical data show consistent octreotide release, effective inhibition of IGF-1, and a safety profile comparable to marketed SSAs, supporting the initiation of this global Phase III study. 

The OXTEND-03 trial is a randomized, three-arm study including a double-blind Debio 4126 group, a placebo control, and an open-label Debio 4126 extension. The trial will follow patients for up to two years, enrolling adults previously treated with octreotide or lanreotide who have normalized IGF-1 levels.