C4X Discovery Holdings (LON:C4XD) said a clinical trial of its molecule to treat opioid addiction is “in sight”, following the selection of Altasciences to conduct a phase I study.
In March last year, C4X signed a licensing agreement with Indivior PLC (LON:INDV) to develop and commercialise its oral Orexin-1 receptor antagonist (C4X_3256/INDV-2000), which aims to treat opioid addiction by targeting the "craving" process, meaning it may be applied across a broad range of substance use disorders.
On Monday, Altasciences revealed that it has been selected by Indivior to conduct a phase I study to assess INDV-2000’s safety, tolerability, and how the drug behaves in the bodies of healthy volunteers, both fasting and fed.
The first part of the two-part study will be double-blind, placebo-controlled, and randomized, with a single-ascending-dose given to fasting volunteers.
The second part will be an open-label study, in which the patients are aware of what they are given, with a single dose to be administered once under fasting conditions and once after eating a standard US Food & Drug Administration (FDA) high-fat breakfast.
The trial will benefit from funding by the US National Institutes of Health (NIH), made to Indivior in the fiscal year 2019 to develop medications to prevent and treat opioid addiction, as the US continues to battle an opioid crisis.
In a statement, C4X’s chief executive, Clive Dix commented: "With initiation of the Phase I clinical trial in sight, and Altasciences and Indivior's expertise in the opioid field, we believe that our molecule has the potential to bring a new alternative treatment for patients suffering in what is a growing epidemic of opioid addiction.”
Altasciences has experience in conducting opioid use disorder trials, as well as conducting NIH-funding clinical studies.