said that it has halted its phase 3b clinical trials for using opiranserin, its non-narcotic analgesics, in treating bunionectomy due to difficulties in recruiting patients during the Covid-19 outbreak in the U.S.

The company has registered patients to participate in the trial since June. It managed to recruit only 42 patients, however, falling far short of the initially targeted 300.

“With the rapid spread of Covid-19 across the United States, the number of patients available has sharply fallen, leading us to decide to discontinue clinically,” the company said. “If the patient registration schedule is delayed, and the clinical progress is slowed down, the quality of clinical data could fall while costing the company more to continue the trials.”

Also, there may be problems with the safety of clinical participants. However, the company stressed that the clinical trials had not been completely stopped. As soon as the situation enters a sedation phase, it will continue to monitor the situation to start its phase 3 clinical trials, it said.

During this period, Vivozon plans to focus on accelerating technology transfer, conduct local phase 3 clinical trial for an injection form of opiranserin, carry out clinical pharmacology studies, and develop VVZ-2471, its neuropathic pain treatment.

“Unfortunately, we had to delay the phase 3 clinical trials in the U.S., but we will push ahead with other tasks and seek to derive lasting results instead of quick ones,” Vivozon CEO Lee Doo-hyun said. “As far as technology transfer of opiranserin is concerned, we initially aimed to discuss the transfer after completing phase 3 clinical result to maximize the value of the drug.”

As foreign companies have requested specific conditions for the technology transfer, the company is considering accelerating the conclusion of such a contract.

corea022@docdocdoc.co.kr

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