Dogwood Therapeutics: Low Dose IMC-2 Reduces Long-COVID Fatigue and Sleep Issues

Dogwood Therapeutics, Inc. (Nasdaq: DWTX), a biotechnology firm focusing on developing treatments for pain and fatigue-related disorders, has announced significant data from the recently concluded Bateman Horne Center (BHC) IMC-2 Long-COVID study. This study, funded through an investigational research grant to the Bateman Horne Center, revealed that a low dose combination antiviral therapy, IMC-2, consisting of valacyclovir 750 mg and celecoxib 200 mg taken twice daily, led to notable reductions in Long-COVID-related fatigue and sleep disturbances when compared to a placebo.

However, the study found that a higher dose regimen of IMC-2, which included valacyclovir 1500 mg combined with celecoxib 200 mg taken twice daily, did not show significant benefits over the placebo. This lack of efficacy at higher doses is thought to be due to increased gastrointestinal side effects associated with the higher dosage.

Dr. Lucinda Bateman, founder and Chief Medical Officer of the Bateman Horne Center and the study’s principal investigator, stated, "Currently, there are no FDA-approved medications specifically for Long-COVID symptoms. Our trial indicates that IMC-2 could potentially alleviate fatigue and sleep issues related to Long-COVID, a finding that merits further investigation in larger, multi-center studies."

Dogwood Therapeutics' Chief Medical Officer, Dr. R. Michael Gendreau, emphasized the importance of the trial's goals. He noted, “The primary objectives of this trial were to ascertain the treatment effect size of IMC-2 compared to a placebo and to determine the required patient sample size for our upcoming Phase 2 Long-COVID study. IMC-2 showed a significant reduction in fatigue, which is the primary endpoint established with the FDA for advancing IMC-2 into Phase 2 development. We are eager to finalize these plans and share further details soon.”

The summary of the IMC-2 Long-COVID Development Program includes two main studies, BHC Study 201 and BHC Study 202. BHC Study 201 was an open-label, matched control study assessing IMC-2 treatment against controls matched by age, duration of effect, vaccination status, and gender. This study, concluded in 2023, showed that the combination of valacyclovir and celecoxib significantly reduced Long-COVID related fatigue, orthostatic intolerance, pain, and anxiety, while also improving overall patient health. The dosage used in this study was valacyclovir 1500 mg and celecoxib 200 mg, taken twice daily.

BHC Study 202, recently completed, was a double-blind, placebo-controlled follow-up to BHC 201. Despite a small sample size (14-15 participants per group), this study demonstrated meaningful clinical improvements in fatigue and sleep disturbances with the low dose combination therapy of IMC-2, compared to the placebo group. Additionally, the adverse event profile for IMC-2 was favorable in this study, although the higher dose treatment led to more gastrointestinal issues compared to the lower dose and placebo groups.

In addition to the IMC-2 program, Dogwood Therapeutics has other promising assets in its pipeline. Halneuron®, a non-opioid Nav 1.7 inhibitor aimed at treating neuropathic pain caused by chemotherapy, is currently in Phase 2b development. Halneuron® has received Fast Track Designation from the FDA for treating Chemotherapy-Induced Neuropathic Pain (CINP) with interim data from the ongoing Phase 2 CINP study expected in the second half of 2025.

Another notable candidate in Dogwood's pipeline is IMC-1, a combination antiviral treatment for fibromyalgia, which is ready for Phase 3 development. IMC-1 has also been granted Fast Track Designation by the FDA as a treatment for fibromyalgia. Dogwood is currently seeking partnerships to advance the Phase 3 program for IMC-1.

Dogwood Therapeutics is dedicated to developing new medications for treating pain and fatigue-related disorders through its innovative research pipeline, which includes both non-opioid analgesic and antiviral programs.