Vivozon wins regulatory nod for 1st phase trial of drug addiction treatment

Vivozon said that it received approval from the Ministry of Food and Drug Safety (MFDS) for the phase 1 clinical trial plan (IND) of its addiction prevention drug, VVZ-2471.

VVZ-2471 is an oral drug that has shown analgesic efficacy and effects on drug addiction caused by morphine and painkillers. In addition, its effect on treating and preventing morphine addiction, inhibiting withdrawal symptoms due to stopping morphine use, and preventing the recurrence of addiction have been proved in non-clinical studies.

For example, when researchers administered VVZ-2471 to mice learning morphine self-administration, it significantly suppressed morphine administration. Even when they administered VVZ-2471 to mice that sufficiently mastered the morphine self-administration, the number of times the lever was pressed for morphine administration significantly dropped, showing an addiction treatment effect.

Also, after inducing withdrawal symptoms in morphine-addicted mice, the withdrawal symptom score of the group receiving VVZ-2471 was significantly lower than that of the control group without drugs. Furthermore, when researchers stopped morphine administration for a period and then exposed them to morphine again to investigate the relapse effect, the VVZ-2471 group demonstrated a significant reduction in their craving for morphine.

Seoul National University Bundang Hospital (SNUBH) will conduct phase 1, a randomized, double-blinded, placebo-controlled, single-dose, and repeated phased increase clinical trial for the safety, tolerability, and pharmacokinetic evaluation of VVZ-2471 oral remedies in healthy adult men.

Drug addiction is a market where the demand for unmet medical care is very high because there is no excellent treatment that currently exists. In the U.S., drug addiction has emerged as a serious social problem, with more than 70,000 deaths annually from addiction and misuse of narcotic analgesics.

"We are finalizing the procedures for clinical initiation and making preparations to start patient registration within two to three months," Vivozon CEO Lee Doo-hyun of Vivozon said, "We will conduct phase 2 clinical trials for morphine addiction and neuropathic pain in the U.S. and Korea, to reinforce the value of the VVZ-2471 pipeline."