Vivozon Healthcare Receives Approval for Phase 2 Clinical Trial of Opilanzerin Topical Agent

Bioson Healthcare CI

[Asia Economy Reporter Chunhee Lee] Vivozon Healthcare announced on the 2nd that the clinical trial plan (IND) for the Phase 2 clinical trial of the non-narcotic analgesic topical agent ‘Opiranjerin (VVZ-149)’ was approved by the Ministry of Food and Drug Safety on the 28th of last month.

This Phase 2 clinical trial targets 90 patients with myofascial pain syndrome. It will be conducted at two locations: Catholic University Seoul St. Mary's Hospital and Catholic University Eunpyeong St. Mary's Hospital. It is a multicenter, randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the analgesic efficacy and safety of Opiranjerin cream.

Vivozon will proceed with the Institutional Review Board (IRB) procedures at each institution for the Phase 2 trial. The IRB is a decision-making body within general hospitals that reviews and approves clinical research to ensure the appropriateness, safety, and ethics of the study for participant safety.

Opiranjerin is a non-narcotic analgesic developed by Vivozon that acts on the central and peripheral nervous systems to provide analgesic effects. Currently, Vivozon Healthcare is conducting Phase 3 clinical trials in Korea, while Vivozon is leading Phase 3 clinical trials in the United States. The Korean Phase 3 clinical trial of Opiranjerin injection is underway at five major hospitals?Seoul National University Hospital, Asan Medical Center, Bundang Seoul National University Hospital, Samsung Medical Center, and Korea University Anam Hospital?targeting 300 patients undergoing colectomy. Since the first patient enrollment in July last year, patient recruitment has been ongoing.

Previously, the Phase 1b/2 clinical trials of Opiranjerin topical agent, which ended early last year, were conducted using a gel formulation. However, to improve the application feel issues such as skin stickiness and greasiness, which are drawbacks of that formulation, the formulation has been changed to a cream form starting from this Phase 2 trial.

Odonghoon, CEO of Vivozon Healthcare, explained, “Unlike the Opiranjerin injection used for postoperative pain, the topical agent has a wider range of use and can be used more broadly by the public, so it can contribute to expanding the base of Opiranjerin.” He added, “We plan to start the clinical trial within the first half of this year.”

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