The Phase II trial will assess the safety and efficacy of the therapy in treating opioid use disorder. Credit: Rohane Hamilton / Shutterstock.

Indivior has dosed the first subject in a Phase II clinical trial of INDV-2000 for individuals with opioid use disorder (OUD).

The double-blind, placebo-controlled, randomised, dose-ranging study aims to evaluate the safety and efficacy of the asset over a three-month period in treatment-seeking participants with moderate to severe OUD.

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It will enrol individuals who have recently initiated or completed short-term medically supervised opioid withdrawal using transmucosal (TM) buprenorphine and are considering a non-opioid treatment alternative.

On the first day, participants will be randomised to receive either INDV-2000 or a placebo alongside TM buprenorphine until day seven.

Following this, INDV-2000 or a placebo will be administered independently from day eight onwards.

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The randomised treatment period will last for three months or until the participant’s final study visit.

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The treatment period may also conclude if a participant requires buprenorphine rescue therapy due to a relapse into illicit opioid use.

INDV-2000, an oral orexin-1 receptor (OX1R) antagonist, has shown promising results in rodent models of addiction and has a safety profile that is suitable for human clinical trials.

This study is supported by a grant under the NIH-HEAL initiative, which is dedicated to the clinical development of new treatments for addiction.

Indivior chief scientific officer Christian Heidbreder said: “INDV-2000 provides Indivior with a unique opportunity to further address unmet patient needs in the treatment of OUD, with potentially the first non-opioid orexin-targeted therapy.

“By providing a potential therapeutic option for patients who might benefit from a non-opioid alternative, INDV-2000 may broaden the spectrum of care for OUD treatment.

“This milestone highlights Indivior’s commitment to developing a wider range of therapeutics in both the opioid and non-opioid treatment category, ultimately providing more choices for the patient.”