Fibromyalgia Treatment: 3 Pillars that Set Virios Therapeutics Apart from the Rest

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

The success of any company most often begins with a solid foundation and strong pillars. These two are essential ingredients to the growth of a company.

Weak foundations or pillars inevitably bring chaos and ultimately the collapse of businesses.

Georgia-based Virios Therapeutics VIRI does not only have a strong foundation but has strong pillars that set it apart from others in its field.

Virios Therapeutics is a clinical-stage biopharmaceutical company developing and commercializing innovative antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, such as fibromyalgia.

Three pillars

The company’s business model runs on three key pillars. These pillars are the heartbeat of its operations and a stimulant for growth.

The company’s first pillar is its decision to focus on a vast dissatisfied market.

Greg Duncan, chairman and CEO at Virios, explained in an exclusive interview with Benzinga.com that “there are three FDA-approved fibromyalgia drugs. The drugs are somewhat effective at reducing pain symptoms but not necessarily well-tolerated, and in my view represents a large significant commercial opportunity.”

Virios uses a unique combination of antiviral therapy, which has not been tested in patients with fibromyalgia.

“There are companies looking at drugs for fibromyalgia, but in our view, their attempts are symptom management rather than what we believe might be a root cause of the disease. So, we are trying to return the virus into dormancy to deliver clinical outcomes and hope for more durable benefits over time,” Duncan noted regarding the company’s novel approach.

Virios Therapeutics has been successful in a “one out of one” trial in the fibromyalgia clinic. Duncan said the success recorded is a great achievement.

The third pillar is the company’s fantastic team. Its team, including a board of directors with significant experience in drug development, has launched two of the three drugs in the space with its lead candidate, IMC-1 — granted fast track designation by the FDA.

“What I also think is interesting is that IMC-1 didn’t just show good efficacy, IMC-1 was better tolerated than even placebo in the Phase 2a study, and I do think those two things could set IMC-1 apart.”

Novel Approach to Treating Virally Mediated Fibromyalgia

​Virios believes that when fibromyalgia patients are exposed to significant life stressors, physical or emotional, it results in abnormal stress and activates a herpes virus mediated-immune response.

Herpes viruses, for example, are unique in that they remain in a dormant state (latency) in neuronal nuclei as nonintegrated, circular DNA associated with nucleosomes, with recurrent reactivations for the host’s life, as seen here.

The company believes it is likely that nerve resident viral herpetic reactivation is necessary for the waxing and waning nociceptive manifestation of fibromyalgia. This cyclical process of virus reactivation and lytic infection of HSV-1 is postulated to perpetuate its symptoms in these patients.

Development of Antiviral Therapies

Virios is also focused on developing combination antiviral therapies for people with debilitating diseases.

The locus of the research program is anchored to a belief that there are many common viruses and specifically herpes simplex virus-1 (HSV-1), which infect the vast majority of adults that can become activated. That activated virus does begin to replicate, which challenges the immune system quite substantially.

“When the immune system gets challenged, we have this tussle between the virus and the immune system. We do believe, based on our mechanistic data or clinical data, by getting that virus back into a dormant state, you can see reductions in disease sequelae for things like fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome,” Duncan observed.

Trials and the FDA 

The trial is designed as a Phase 3-like trial because the inclusion criteria, endpoints, exclusion criteria and therapy duration are consistent with Phase 3 requirements.

After the trial, Virios plans to make a case for it to be part of the company’s registration package.

“We’ll harvest P2b data in the middle of 2022 and engage the FDA, and then we’ll decide whether we want to go alone, consider a partnership or other means to develop the drug.”

Duncan is confident that the company’s drug has commercial potential and will garner interest from spec pharma and large pharma companies.

“People talk about blockbuster drugs all the time, but there are very few of those in the marketplace. I believe there’s a lot of great potential for a safe and effective FM drug in the U.S. alone, which I think it will garner some external partnership interest,” Duncan concluded.

With its fast-track review designation, the company is hopeful that with good data in the Phase 2b trial, it can accelerate discussions with the FDA to have a relatively quick launch date of the end of 2025 or the beginning of 2026.

Read more about trials and treatments by Virios Therapeutics here: PIPELINE.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.