In a shocking failure, Virios Therapeutics announced this morning pre-market that topline results from its FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1 (“HSV-1”)) study of oral IMC-1 for the treatment of fibromyalgia did not achieve statistical significance.
Since market open, the stock price has dropped a massive 70% from $8.77 at market close on Friday, September 16th. NASDAQ: VIRI is currently trading at $2.58 as of publication wiping out over $50 Million in company market cap and valuation.
The Atlanta-based development-stage biotechnology company is focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, including fibromyalgia.
FORTRESS Fibromyalgia Clinical Trial Overview
The FORTRESS study was a placebo-controlled safety and efficacy study of IMC-1 antiviral combination therapy that enrolled 425 patients. All the patients were female, aged 18 to 65, and met the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia.
For the study, participants were assigned to either IMC-1 or placebo control for the duration of the study. Each patient was randomized 1:1 to IMC-1 or a matching placebo. Three patients were enrolled and randomized, but no data were acquired, therefore they are not included in our study’s statistical analysis plan.
The FORTRESS study’s main goal was to measure the average weekly pain severity (as documented in patients’ daily diaries) from baseline until Week 14. The Numerical Rating Scale used for this primary endpoint goes from 0-10, with a higher score indicating more severe pain.
The treatment period began with patients meeting the researchers at a clinical site to complete a pain diary that they kept at home daily. The study also evaluated IMC-1’s capacity to relieve fatigue and sleep disruption, as well as measurable improvements in overall global health status and patient function, in FM patients.
The Virios Therapeutics team received updated data relating to the FORTRESS study on Friday, September 16, 2022. In a morning presentation the company showed a side by side comparison to the 3 other approved fibromyalgia treatments that are FDA approved, despite the trial’s failure hoping to grasp any connection they can to the winning drugs that include Abbvie‘s Savella, Eli Lilly and Company‘s Cymbalta & Pfizer‘s Lyrica.
Virios Therapeutics Trial Failure
According to Virios Therapeutics, the FORTRESS study did not meet statistical significance on the primary end point of change from baseline to Week 14 in the weekly average of daily self-reported average pain severity scores comparing IMC-1 to placebo (p=0.302).
The firm is attempting to repair the damage, arguing that the findings suggest a split in response based on when patients enrolled in the FORTRESS trial considering various elements of COVID-19.
Virios stated that during the first half of the trial (June 2021 to November 2021), for the patients who were enrolled at a time when the Delta variant of COVID-19 was highly common in the U.S., IMC-1 demonstrated no improvement versus placebo-treated patients.
In the second half of the trial, as vaccination rates improved and patients who were enrolled when less severe strains became dominant in America began receiving treatment with IMC-1, those treated showed significant improvement from Week 14 onward on primary pain reduction (p=0.03), key secondary PROMIS Fatigue assessment scores (p=0.006), and Fibromyalgia Impact Questionnaire-Revised symptoms domain score (p=0.015).
IMC-1 Safety & Efficacy
Out of all the patients that were administered IMC-1, only 4.6% stopped taking it because of negative side effects. This is in comparison to 8.1% of those who took the placebo and experienced similar issues. The number of people experiencing problems with any one particular category didn’t exceed 4%, except for COVID-19 infection rates.
In the IMC-1 treated group, 18.5% of patients discontinued using overall, while 23% in the placebo group did likewise. In the FORTRESS trial, patients were randomized one-to-one to either IMC-1 or placebo. Patient background demographics and baseline pain scores showed little difference between groups.
Virios Therapeutics Executive Commentary on Trial Failure
Greg Duncan, CEO and Chairman, stated the company was surprised by the overall primary efficacy result from this study, as they believe the approach continues to have scientific validity and the potential to provide FM patients with a much-needed, well-tolerated therapeutic option.
He was quoted as stating, “We believe the interplay between different COVID-19 strains and herpes virus activation may be contributing to the differential response we observed in patients enrolled in 2021 versus 2022.”
In regards to plans, Duncan stated “Our team and outside advisors are in the process of further analyzing the FORTRESS data, and we will provide an update on our overall plan to advance the development of IMC-1 as soon as possible.”
R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics also shared his thoughts stating, “Overall, the efficacy data from this trial were not what we had expected. We will continue to explore IMC-1’s potential as a viable FM treatment option. We would like to thank all of the investigators and patients who participated in FORTRESS for their support of this important research.”
About IMC-1
IMC-1 is a new, exclusive fixed dose combination of famciclovir and celecoxib. This dual antiviral therapy suppresses HSV-1 activation and replication together to lessen viral mediated disease burden.
The IMC-1 combination of two distinct mechanisms of action is designed to keep HSV-1 in a latent (dormant) state or “down-regulate” HSV-1 from a lytic (active) state back to latency.
IMC-1 features famciclovir, which blocks viral DNA replication by inhibiting the virus’ necessary polymerase enzymes. Additionally, celecoxib in IMC-1 prevents two other types of enzymes (COX-2 and COX-1) from accelerating HSV-1 replication.
The combination of famciclovir and celecoxib found by Virios Therapeutics is protected by a U.S. “Composition of Matter” Synergistic Patent (US 10,251,853).
About Virios Therapeutics
Virios Therapeutics is a development-stage biotechnology company dedicated to developing new antiviral therapies to treat chronic diseases, such as fibromyalgia (“FM”).
Some researchers believe that immune system reactions to the activation of tissue-resident herpes viruses may be responsible for chronic illnesses such as fibromyalgia (FM), irritable bowel disease, chronic fatigue syndrome, and other functional somatic syndromes. These disorders are characterized by symptoms that come and go over time, with no clear cause.
The lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib that aims to synergistically suppress herpes virus replication and reduce virally induced disease symptoms. The FDA has fast tracked IMC-1.
The Company is also investigating IMC-2 (valacyclovir and celecoxib) as a possible solution to the fatigue, sleep, attention, pain, autonomic function and anxiety issues often seen in Long-COVID patients, otherwise known as Post-Acute Sequelae of COVID-19 (PASC).
The Company has given Bateman Horne Center (“BHC”) an unrestricted exploratory funding to conduct this research. BHC is a non-profit, interdisciplinary Center of Excellence that seeks to diagnose and treat chronic fatigue illnesses, FM, post-viral syndromes, and related comorbidities.
