The trial was funded by an investigational research grant from the Bateman Horne Center and involved a double-blinded, placebo-controlled design with small sample sizes of 14-15 participants per group.

Dogwood Therapeutics plans to finalize their Phase 2 study details and provide further updates in the upcoming months.

The findings support the planning of larger Phase 2 studies to further investigate IMC-2 as a treatment for long-COVID.

Interim data from the ongoing Phase 2 study for Halneuron® is expected in the second half of 2025, and Dogwood is seeking partnerships for the Phase 3 study of IMC-1 for fibromyalgia.

Dogwood Therapeutics has announced promising results from its IMC-2 Long-COVID study, which demonstrated significant reductions in fatigue and sleep disturbances compared to a placebo.

The trial's primary goal was to assess treatment effects and determine the optimal sample size for future studies, focusing on advancing IMC-2 into Phase 2 development.

The treatment regimen for the study included valacyclovir 750 mg and celecoxib 200 mg taken twice daily, which proved effective, while a higher dose regimen did not show similar benefits due to increased gastrointestinal side effects.

In addition to IMC-2, Dogwood Therapeutics is developing Halneuron®, a non-opioid analgesic for chemotherapy-induced neuropathic pain, and IMC-1, an antiviral treatment for fibromyalgia, both of which have received FDA fast track designations.

Dr. Lucinda Bateman, the principal investigator of the study, highlighted the importance of these findings, especially given the lack of FDA-approved treatments for Long-COVID symptoms.

The study's results indicate a robust reduction in fatigue, which was the primary endpoint agreed upon with the FDA for advancing IMC-2 into Phase 2 development.

Earlier research, specifically BHC Study 201, indicated that the combination of valacyclovir and celecoxib resulted in significant reductions in fatigue, pain, and anxiety.

The adverse event profile of the low-dose IMC-2 was favorable, while the high-dose treatment resulted in more gastrointestinal issues and did not show meaningful differences from placebo.