Vivozon Applies for IND for Domestic Phase 2 Clinical Trial of Pain and Addiction Treatment ‘VVZ-2471’

Vivozon announced on the 25th that it has submitted an Investigational New Drug application (IND) to the Ministry of Food and Drug Safety (MFDS) for the Phase 2 clinical trial of the oral drug candidate ‘VVZ-2471’ for neuropathic pain. This marks the beginning of Vivozon’s full-scale development of oral pain and addiction treatment drugs.

The clinical trial will be conducted at Seoul St. Mary’s Hospital with 90 patients suffering from postherpetic neuropathic pain. The principal investigator, Professor Park Hoojeong of the Department of Anesthesiology and Pain Medicine, plans to administer either a placebo or VVZ-2471 twice daily (100mg, 150mg) for 4 weeks to test the analgesic efficacy of VVZ-2471.

Postherpetic neuralgia is a neuropathic condition where pain becomes chronic even after the herpes zoster infection has healed, and it is known to be very difficult to treat.

Lee Doohyun, CEO of Vivozon, explained, “VVZ-2471, as an oral analgesic, can be used complementarily with the injectable Opiranserin. Immediately after surgery, patients often experience severe nausea and vomiting as side effects, making oral pain medication difficult to take, so injectable drugs are used initially. From the point when side effects decrease, VVZ-2471 can be administered orally to control postoperative pain.”

He added, “This time, we are conducting the clinical trial first on neuropathic pain, which is expected to progress quickly, while also serving as a dose-finding study. We also plan to initiate a Phase 2 clinical trial for postoperative pain.”

VVZ-2471 is a candidate drug discovered through Vivozon’s multi-target drug discovery platform technology. Previous preclinical studies have demonstrated its excellent efficacy in treating acute and chronic pain as well as drug addiction. Last year, Vivozon confirmed the tolerability and safety of a 400mg capsule administered once daily for 7 days in a Phase 1 clinical trial of VVZ-2471 conducted at Bundang Seoul National University Hospital.

Additionally, VVZ-2471 is based on the mechanism of action of Opiranserin (VVZ-149), which is undergoing domestic approval procedures through Vivozon Pharma (082800). The company believes that by using an mGluR antagonist with similar function instead of the GlyT2 inhibitor among Opiranserin’s 5HT2A antagonist and GlyT2 inhibitor components, VVZ-2471 is a highly promising candidate for future clinical success.

Vivozon plans to conduct a Phase 2 clinical trial of VVZ-2471 as a drug addiction treatment in the United States.

A Vivozon representative stated, “In May, we plan to apply for the new drug development support program of the U.S. National Institute on Drug Abuse (NIDA) together with addiction specialists in the U.S. If selected for this program, Vivozon will be responsible for the necessary preclinical research for addiction treatment drug development, while local specialists will conduct the Phase 2 clinical trial.”