Debiopharm enrolls first patient in Phase III acromegaly trial

Debiopharm has enrolled the first participant in its worldwide Phase III clinical trial, OXTEND-III, designed to evaluate the safety and effectiveness of Debio 4126 in adults with acromegaly currently treated with somatostatin analogues. Acromegaly is a rare and persistent hormonal disorder caused by excessive production of growth hormone from the pituitary gland.

The trial will investigate a long-acting octreotide formulation across 75 sites in 21 countries, aiming to recruit approximately 120 patients. Participants have previously been treated with octreotide or lanreotide and exhibit Insulin-like Growth Factor 1 (IGF-1) levels within the normal range.

The primary goal is to determine if Debio 4126 can maintain biochemical control of acromegaly while reducing injection frequency from 12 times per year to four, potentially enhancing patient convenience and long-term adherence. Debio 4126 is administered via intramuscular injection every three months, with early clinical results and pharmacokinetic studies showing sustained octreotide levels.

Yanina Negievich, Medical Director of the Debio 4126 Program at Debiopharm, stated: Initiating dosing for the first participant in OXTEND-III is a significant milestone for our team and demonstrates our commitment to addressing critical needs in rare diseases. Our aim with Debio 4126 is to simplify treatment, allowing patients to move from monthly to quarterly injections, improving quality of life and enabling them to focus on living rather than managing their condition.

Sources:

• Debiopharm randomises first patient in Phase III acromegaly trial