Vivozon Pharmaceutical affiliate Vivozon said on the 6th that it identified a trend of pain improvement centered on the high-dose group in phase 2 of the oral (pill) non-opioid analgesic candidate VVZ-2471.
VVZ-2471 is an oral non-opioid analgesic candidate derived from technology used to discover the non-opioid painkiller Onapraju. It has a dual mechanism of action that simultaneously modulates the metabotropic glutamate receptor (mGluR5) and the serotonin 2A receptor (5-HT2A). The company is pushing development of this as a next-generation oral drug candidate targeting chronic neuropathic pain, including postherpetic neuralgia (PHN), and the addiction treatment field.
This phase 2 trial was an exploratory study with about 30 patients per arm, aimed at assessing the potential for efficacy rather than definitively proving a treatment effect. The trial was conducted as a randomized, double-blind, placebo-controlled study and evaluated changes in weekly pain intensity as the primary endpoint. Participants were assigned to the 150 mg group, 100 mg group, or placebo group and took the drug twice a day.
According to the company, in the VVZ-2471 high-dose (150 mg) group, pain reduction was continuously observed from week 1 through week 4 of dosing.
In particular, at week 4, the proportion of patients with a 40% or greater reduction in pain from baseline was 32%, about twice as high as the placebo group (15%). No overall serious safety issues were identified, and adverse events such as mild dizziness and nausea showed a pattern similar to the prior phase 1.
Regarding these results, the company said they were interpreted as an exploratory signal at a level similar to clinical data for the existing postherpetic neuralgia treatment pregabalin.
A Vivozon official said, "Given that this phase 2 was an exploratory clinical trial with about 30 patients per arm, the results are meaningful," and added, "Assuming the generally applied 150 or more patients per arm in a confirmatory phase 3, the high-dose group was analyzed to be able to reach statistical significance." The official continued, "In particular, the fact that the proportion of responders achieving 40% or more pain reduction in the high-dose group was about twice that of the placebo group is very encouraging, and we plan to demonstrate efficacy and safety through subsequent trials after securing a sufficient dosing period and number of participants."
Meanwhile, VVZ-2471 is being developed domestically and internationally with simultaneous support from the pan-ministry new drug development project and the National Institutes of Health (NIH). Recently, a public consent petition to the National Assembly called for reducing the use of opioid analgesics and supporting the development of non-opioid painkillers and addiction treatments.