By Chris Wack


Virios Therapeutics Inc. shares were up 52% to 95 cents on Tuesday after the company said late Monday that it received initial feedback from the U.S. Food & Drug Administration on its Phase 3 program proposal featuring its lead development candidate IMC-1.

The Atlanta-based, clinical-stage biopharmaceutical company said its IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted fibromyalgia disease symptoms.

The feedback was provided following a guidance meeting between the Anesthesiology, Addiction Medicine and Pain Medicine division of FDA and the company in March.

Initial FDA feedback was that the company's Phase 3 proposal is acceptable, subject to review of the final results from its recently completed chronic toxicology program. Virios will submit the final toxicology reports and associated data in May.

An updated Phase 3 program proposal, responsive to FDA guidance, will also be provided once the FDA completes its review of the chronic toxicology reports.

The stock closed Monday's session down 8% and is down 77% in the past 12 months.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

04-25-23 1330ET