FDA deems IMC-1 chronic toxicology program adequate; Virios plans Phase 3 start mid-2024

Dogwood Therapeutics, Inc.

FDA communicated that IMC-1 chronic toxicology studies appear adequate to support safety at proposed dose for chronic use.
Virios plans to initiate a pharmacokinetic (pK) study this year and resubmit final Phase 3 program outline and protocols to FDA.
Goal to begin enrollment in first fibromyalgia Phase 3 safety and efficacy study in mid-2024.
Phase 3 plan includes two adequate and well-controlled studies and a long-term extension trial targeting community-based FM patients.
Company to use 505(b)(2) regulatory pathway; FORTRESS Phase 2b results informed Phase 3 design.

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