Our lead development candidate (“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 disease symptoms. Evidence of IMC-1’s efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. In this trial, IMC-1 delivered statistically significant reduction in FM related pain, fatigue, anxiety and depressive symptoms and improved overall patient health and functioning. IMC-1 was better tolerated placebo, as evidenced by a lower drop-out rate due to adverse events on IMC-1 as compared to placebo.
Virios’ novel FM development candidate, IMC-1, demonstrated exemplary safety and tolerability in the FORTRESS study (a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of over 400 FM patients), but did not achieve statistical significance on the pre-specified primary efficacy endpoint of change from baseline in daily self-reported average pain severity scores compared to placebo. However, analysis of the top-line data revealed a bifurcation of response based on the timing of patient enrollment in the FORTRESS study that the Company believes is unlikely related to chance. Based on these results, the Company performed a deeper analysis of the FORTRESS data to determine factors driving these results to determine whether, and if so, how, to continue the development of IMC-1.
Post-hoc analysis of the FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1) study results indicated that FM patients who were generally more naïve to prior clinical studies and prior FM drug treatment (“new” patients), demonstrated clinically and statistically significant reductions in pain, fatigue, FM symptoms and both anxiety and depression symptoms. In contrast, FM patients who were prior FM trial participants and/or study site database patients (“experienced” patients) did not exhibit a statistically significant treatment benefit in this study.
The Company believes targeting new FM patients for IMC-1 development is the optimal approach and plans to meet with the U.S. Food & Drug Administration (“FDA”) with the goal to progress IMC-1 into Phase 3 development.
About IMC-2: The Company is pursuing a second development candidate, IMC-2 (valacyclovir and celecoxib), as a potential treatment for managing the fatigue, sleep, attention, pain, autonomic function and anxiety associated with Long COVID, otherwise known as Post-Acute Sequelae of COVID-19. The Company has provided Bateman Horne Center (“BHC”) with an unrestricted grant to conduct this study. BHC is a non-profit, interdisciplinary Center of Excellence advancing the diagnosis and treatment of myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), FM, post-viral syndromes, and related comorbidities.