Thumb Tenosynovitis Opiranezin Phase 3b Clinical Trial Results Expected by Late December
Excluding Patients with Mild Pain Below Intensity 4 Post-Surgery
Focus on Demonstrating Efficacy through Rescue Medication Dose Adjustment
[Asia Economy Reporter Hyungsoo Park] Vivozon, a company developing new drugs for pain and central nervous system diseases, disclosed on the 18th the progress of the phase 3b clinical trial of the non-opioid analgesic injection ‘Opiranzerin (VVZ-149)’ for hallux valgus (mooji oebanjeung).
The phase 3b clinical trial for hallux valgus, conducted at clinical institutions in Arizona, California, Texas, and other locations in the United States, will begin patient screening after the 17th local time. Surgery will be performed on patients who pass the selection criteria, and patient enrollment will start in early July.
Last November, Vivozon produced positive results in the phase 2b clinical trial for hallux valgus. Although the number of patients was small and the primary efficacy endpoint?the difference in 12-hour pain area under the curve?did not reach statistical significance, it was confirmed that with a sufficient number of subjects, the difference could achieve significance. Additionally, with a total of 60 patients, a statistically significant difference was shown in the percentage of patients detecting analgesia, proving Opiranzerin’s rapid pain relief effect.
The phase 3b trial is a confirmatory study to definitively verify the efficacy of Opiranzerin, with a refined design based on the previous phase 2b trial to increase the likelihood of success. The goal is to enroll a total of 300 patients, excluding those with mild pain having a post-surgery pain intensity below 4. The strategy is to reduce the opioid dosage used as rescue medication compared to the previous phase 2b trial to secure a difference from the placebo group.
Lee Doohyun, CEO of Vivozon, said, "In the 30-year history of analgesic development, there have been very few cases showing positive results in phase 2 trials," adding, "Opiranzerin is repeatedly producing results very close to being a ‘safe yet powerful analgesic.’"
He continued, "Based on the analysis of existing clinical trial data, we predict successful results with an optimized protocol and patient number," emphasizing, "We will accelerate efforts to produce topline results as early as late December this year to early January next year."
Vivozon is preparing clinical development for two follow-up candidate substances. One is a drug developed for neuropathic pain and drug addiction indications, currently entering the preclinical toxicity testing phase. No serious toxicity was found in Vivozon’s own toxicity tests. It is expected to enter clinical trial stages in the fourth quarter of next year. The other is a follow-up analgesic substance to Opiranzerin, planned to enter the preclinical toxicity testing phase this year, with a strategy to replace the market after Opiranzerin’s patent expiration.
Vivozon’s core pipeline, the Opiranzerin (VVZ-149) injection, is a non-opioid analgesic with strong pain relief efficacy for moderate or greater pain, including postoperative pain. Its efficacy has been repeatedly demonstrated through five previous phase 2 clinical trials. Consistently, no clinically notable serious adverse effects have been reported in clinical trials, confirming excellent tolerability and safety.
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