Initial FDA feedback on proposed IMC-1 phase III program for treatment of fibromyalgia

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. This feedback was provided following a guidance meeting between the Anesthesiology, Addiction Medicine and Pain Medicine division of FDA and the Company in March 2023.

Key IMC-1 Phase III Program Proposal Highlights: i. The proposed Phase III program consists of four primary components: two adequate and well-controlled clinical studies, one of which would be a full factorial design with each of the individual components of IMC-1 (famciclovir and celecoxib) as separate comparator arms, a long-term safety trial, and a pharmacokinetic/food effect study. ii Based on data from the recently completed FORTRESS Phase IIb trial, the Company proposed a Phase III development program targeting community-based FM patients, who have not participated in prior FM trials. iii. Initial FDA feedback was that the Company’s Phase III proposal is acceptable, subject to review of the final results from its recently completed chronic toxicology program. The Company will submit the final toxicology reports and associated data in May 2023. iv. An updated IMC-1 Phase III program proposal, responsive to FDA guidance, will also be provided once FDA completes its review of the chronic toxicology reports.

There is significant unmet medical need in the FM patient community, as reflected by the fact that existing treatments do not work for all patients and no new pharmaceutical treatments have been approved by FDA to treat FM over the past decade. The Company will provide material progress updates as it continues to work with FDA with the goal of advancing IMC-1 into Phase III development as a potential new treatment option for the FM patient community.