Debiopharm, a privately-owned Swiss biopharmaceutical company focused on oncology and rare diseases, announced that the first patient has been enrolled in its OXTEND-03 Phase III clinical trial. The study evaluates Debio 4126, the first long-acting octreotide formulation designed for dosing every three months.
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OXTEND-03 is a global, multi-center, randomized trial spanning approximately 75 sites in 21 countries. The study aims to enroll around 120 adults with acromegaly who are currently maintained on somatostatin analogues. The primary goal is to determine whether Debio 4126 can maintain biochemical control while reducing the treatment burden from 12 injections per year to just four, improving patient convenience, adherence, and potentially lowering healthcare resource use.
Yanina Negievich, Medical Director for the Debio 4126 Program at Debiopharm, said that enrolling the first patient marks a significant milestone and demonstrates the company’s dedication to addressing high unmet needs in rare diseases. She emphasized that Debio 4126 is designed to simplify treatment for patients, allowing them to focus more on living their lives rather than managing frequent injections.
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Maria Fleseriu, MD, FACE, professor and director of the pituitary center and global principal investigator of the study, explained that monthly injections pose a substantial physical and emotional burden on patients with acromegaly. She added that a quarterly dosing schedule could transform disease management by maintaining control while reducing treatment stress and improving overall quality of life.
Acromegaly is a rare endocrine disorder caused by excessive production of growth hormone by the pituitary gland, affecting between 28 and 137 people per million. Standard medical therapy involves lifelong monthly injections of somatostatin analogues, which can cause pain, swelling, and bruising at injection sites and often fail to fully resolve symptoms or restore quality of life. Debio 4126 addresses these challenges by providing a long-acting formulation that maintains biochemical control while reducing injection frequency.
Debio 4126 delivers sustained release of octreotide through intramuscular administration every three months. Early clinical data and pharmacokinetic modeling support its ability to maintain stable insulin-like growth factor 1 levels and demonstrate a safety profile comparable to current somatostatin analogues. These findings formed the basis for launching this pivotal Phase III trial.
The OXTEND-03 trial uses a three-arm design including double-blind Debio 4126, placebo control, and an open-label Debio 4126 extension. Participants will include adults previously treated with octreotide or lanreotide who have normalized IGF-1 levels. The study is expected to continue for up to two years, providing critical data to support Debio 4126 as a less burdensome option for long-term acromegaly management.
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