Indivior initiates Phase 2 study for INDV-2000, targeting opioid use disorder with non-opioid treatment

Indivior PLC (LSE/Nasdaq: INDV) has announced the commencement of a Phase 2 clinical trial involving INDV-2000, a non-opioid treatment, marking a significant advancement in the battle against Opioid Use Disorder (OUD). This double-blind, placebo-controlled, randomized study is designed to assess the safety and efficacy of INDV-2000 over a three-month period in individuals with moderate to severe OUD.

The trial has begun with the dosing of the first participant and aims to establish a dose-response relationship for INDV-2000, targeting individuals who are treatment-naïve, have recently initiated or completed short-term medically supervised opioid withdrawal, and are seeking to transition to non-opioid treatments. The study’s significance is underlined by its design to streamline participants’ transition away from opioid dependence, aiming for substantial outcomes in safety and efficacy.

INDV-2000, an oral orexin-1 receptor (OX1R) antagonist, represents a pioneering approach within the realm of addiction treatment, focusing on the orexin pathway, which is critical in the neurobiology of addiction. The medication has shown promising results in animal studies, demonstrating the potential to reduce the intake and self-administration of opioids and synthetic opioids like fentanyl and remifentanil. These findings support the hypothesis that OX1R plays a significant role in the motivational and reward systems affected by opioid addiction.

Christian Heidbreder, Chief Scientific Officer at Indivior, highlighted the innovative nature of INDV-2000, stating, “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.” He further emphasized the broader implications for patient care, suggesting that INDV-2000 could significantly broaden the spectrum of care available for treating OUD.

The clinical development of INDV-2000 has been supported by an NIH-HEAL grant, underscoring its potential impact in addressing the ongoing opioid crisis. This support has facilitated the progression of INDV-2000 from early-stage research through to this current phase of clinical trials.

The opioid epidemic continues to pose significant challenges globally, with millions affected by opioid misuse annually. The development of new treatments like INDV-2000 is critical in providing effective alternatives to current opioid-based treatments, offering hope for more sustainable and safe recovery options for individuals suffering from OUD.

This Phase 2 study not only aims to confirm the safety and effectiveness of INDV-2000 but also to streamline the development of further non-opioid treatments that can be integrated into broader therapeutic strategies against OUD.