Vivozon Doses First Patient in Phase 1 Trial of Non-Opioid Painkiller Under U.S. NIDA Research Project

Vivozon, an affiliate of Vivozon Pharmaceutical, to begin Phase 1 clinical trial of non-opioid painkiller candidate

Vivozon said on November 10 that the first patient had been dosed in a Phase 1b trial of VVZ-2471, an oral non-opioid painkiller candidate, as part of a research project.

The study is a project selected for support by the National Institute on Drug Abuse (NIDA), part of the U.S. National Institutes of Health (NIH). Vivozon previously received approval from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application. The trial, which is for opioid use disorder (OUD), is being led by Virginia Commonwealth University (VCU).

The primary objective of the trial is to evaluate safety and tolerability with repeated dosing. It is intended to generate safety data and provide a basis for clinical trial design for future development in patients with OUD, and the findings are expected to inform plans for subsequent development.

VVZ-2471 is an oral non-opioid painkiller candidate with a dual mechanism of action that modulates serotonin receptor 2A (5-HT2A) and metabotropic glutamate receptor 5 (mGluR5) simultaneously. Its mechanism is based on the dual modulation of receptors involved in the central nervous system's reward circuitry and the regulation of craving.

In South Korea, the company has completed a Phase 2 trial for postherpetic neuralgia (PHN) and is analyzing the data. It is also building a clinical data portfolio in the pain treatment area.

A Vivozon representative said, "VVZ-2471 is being developed as a candidate with a non-opioid mechanism that differentiates it from existing opioid-based drugs. Through the VCU-led trial, we plan to demonstrate its potential as an OUD treatment in stages."

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