Debiopharm has randomised the first patient in the global Phase III clinical trial, OXTEND-III, to assess the safety and efficacy of Debio 4126 in adults with acromegaly who are maintained on somatostatin analogues at present.
Acromegaly is a rare chronic endocrine disorder caused by excessive growth hormone production by the pituitary gland.
The study of the long-acting octreotide formulation will be conducted at 75 sites in 21 countries, enrolling around 120 patients.
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Patients in this study previously received octreotide or lanreotide and have Insulin-like Growth Factor 1 (IGF-1) levels within the normal range.
The primary objective is to confirm whether Debio 4126 can sustain biochemical control of acromegaly while decreasing the number of injections from 12 annual doses to four, which may improve subject convenience and long-term adherence.
Debio 4126 is intended for intramuscular injection to be given every three months. Preliminary clinical results and pharmacokinetic modelling indicate that it delivers sustained octreotide levels.
Debiopharm Debio 4126 Program medical director Yanina Negievich said: “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.
“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.”
In May 2023, Debiopharm dosed the first patient in a Phase I trial of Debio 0123 combined with carboplatin and etoposide to treat recurrent or progressive small cell lung cancer (SCLC) in patients following a standard platinum-based chemotherapy.
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