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

[Asia Economy Reporter Lee Gwan-joo] Vibozone Healthcare announced on the 30th that it has commenced Phase 2 clinical trials of Opiranzerin (VVZ-149) topical formulation, a non-narcotic analgesic developed by Vibozone.

The Opiranzerin topical formulation recently received approval from the Institutional Review Board (IRB) and completed the Site Initiation Visit (SIV) with clinical institutions. The IRB is a decision-making body within general hospitals that reviews the appropriateness, safety, and ethics of research to approve clinical studies for participant safety.

The Phase 2 clinical trial of Opiranzerin topical formulation will involve 90 patients with myofascial pain syndrome and will be conducted at The Catholic University of Korea Seoul St. Mary's Hospital and Eunpyeong St. Mary's Hospital. This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the analgesic efficacy and safety of Opiranzerin cream.

The Phase 1b/2 clinical trials of Opiranzerin topical formulation, which concluded last year, were conducted using a gel formulation. However, to improve the application feel by addressing drawbacks such as stickiness and greasiness of the gel, the formulation has been changed to a cream starting from this Phase 2 trial. Vibozone Healthcare acquired the development rights for the non-narcotic analgesic Opiranzerin topical formulation in October 2020 and is currently conducting domestic clinical trials.

Lee Doo-hyun, Chairman of Vibozone Healthcare, stated, “With all preclinical procedures completed, we plan to actively recruit patients, and we expect the first patient enrollment soon. We will demonstrate the excellence of the non-narcotic analgesic Opiranzerin in both injectable and topical formulations.”

Meanwhile, Opiranzerin is a new drug that acts on the central and peripheral nervous systems to provide analgesic effects. Currently, Vibozone Healthcare is leading the Phase 3 clinical trial in Korea for the injectable form, while Vibozone is leading the Phase 3 clinical trial in the United States. The domestic Phase 3 clinical trial of Opiranzerin injectable is being conducted at five sites?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. Patient enrollment has been ongoing since the first patient was registered in July last year.