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news.Adolor, a biopharmaceutical company specialising in the discovery, development and commercialisation of novel prescription gastrointestinal and pain management products, has initiated a Phase 2 proof-of-concept (PoC) study of ADL5945 in patients with opioid-induced constipation (OIC).
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ADL5945, licensed from Eli Lilly and Company in 2009, is a proprietary, peripherally-acting mu opioid receptor antagonist.
Adolor plans to recruit about 120 patients in the trial, to evaluate two doses of ADL5945 (0.10mg and 0.25mg given twice daily) versus placebo over a four week period.
The primary endpoint of the study will be change from baseline in the weekly average of spontaneous bowel movements (SBMs) during treatment.
In a recently completed SAD and MAD studies of ADL5945 and ADL7445, both compounds were well-tolerated and, in the patients with OIC, produced increases in weekly average SBMs compared to placebo.
Adolor president CEO Michael Dougherty said that they begin this study having just completed a single-ascending dose (SAD) study of ADL5945 in healthy volunteers and a multiple-ascending dose (MAD) study in OIC patients with chronic non-cancer pain.
"The results were highly encouraging on all fronts: PK profile, tolerability and efficacy. We look forward to the completion of this trial next summer," Dougherty said.