Virios Therapeutics shares more than doubled after the biotechnology company announced that its proposed Phase 3 program featuring its lead development candidate IMC-1 for fibromyalgia has been considered acceptable based on initial feedback from the US Food and Drug Administration (FDA).
IMC-1 is a novel, fixed-dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the company’s end goal being the reduction of virally promoted fibromyalgia disease symptoms.
The proposed Phase 3 program consists of four parts: two clinical studies, a long-term safety trial, and a pharmacokinetic/food effect study.
The company said on Monday that its proposed program was considered acceptable by the FDA, pending the review of the final chronic toxicology program reports and associated data which Virios will submit in May 2023.
Virios received this feedback from the FDA following a guidance meeting between the company and the FDA’s Anesthesiology, Addiction Medicine and Pain Medicine division in March 2023, it said.
Once the FDA has reviewed the chronic toxicology reports and provided guidance, Virios said it will provide an updated IMC-1 Phase 3 program proposal.
“The company will provide material progress updates as it continues to work with FDA with the goal of advancing IMC-1 into Phase 3 development as a potential new treatment option for the fibromyalgia patient community,” Virios said in a statement.
Investors welcomed the update, with the company’s stock doubled to US$1.26 on Tuesday morning.
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