Lengthy COVID Impacts Up To 30% of COVID-19 Sufferers
Activation of Dormant Herpes Virus Infections are Hypothesized as a Potential Set off of Lengthy COVID
Mixture Remedy with IMC-2 (valacyclovir and celecoxib) Expands Virios’ Pipeline
ATLANTA, February 28, 2022–(BUSINESS WIRE)–Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology firm targeted on advancing novel antiviral therapies to deal with persistent ailments, together with fibromyalgia, introduced at the moment a collaboration with the Bateman Horne Middle (“BHC”) of Salt Lake Metropolis, Utah, to discover the function of mixture antiviral remedy in Lengthy COVID, in any other case often called Submit-Acute Sequelae of COVID-19 . The Bateman Horne Middle is a non-profit, interdisciplinary Middle of Excellence advancing the analysis and remedy of myalgic encephalomyelitis/persistent fatigue syndrome (“ME/CFS”), fibromyalgia (“FM”), post-viral syndromes, and associated comorbidities.
Virios Therapeutics, Inc. is offering BHC with an unrestricted grant for an investigator-sponsored research to discover the therapeutic potential of mixture antiviral remedy with Virios’ second improvement candidate, IMC-2. The research will consider modifications in widespread Lengthy COVID signs corresponding to fatigue, sleep, consideration, ache, autonomic operate and anxiousness.
“We’re happy to assist the Bateman Horne Middle, a number one scientific analysis heart in post-viral syndromes, as they research the therapeutic potential of IMC-2 to ease the burden of Lengthy COVID, which is an rising healthcare disaster,” mentioned Greg Duncan, Chairman and CEO of Virios Therapeutics Inc.
In line with the World Well being Group, COVID-19 has induced greater than 373 million infections and greater than 5.6 million deaths as of January 2022. Revealed estimates within the scientific literature counsel that as much as 30% will expertise Lengthy COVID signs. It’s estimated that one in three sufferers who develop Lengthy COVID signs had been asymptomatic throughout their acute COVID-19 an infection. The mechanisms by which COVID-19 causes lingering signs aren’t nicely understood. Potential triggers for long run signs may embody:
Immune-system dysregulation triggered by the COVID-19 virus, together with elevated manufacturing of autoantibodies,
Lingering or re-infection with COVID-19 variants, and
Co-infection or activation of earlier viral infections that had turn out to be dormant
“Most adults are contaminated with usually innocent dormant viruses contracted years earlier,” mentioned R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. “It’s turning into more and more clear that COVID-19 acutely depresses our immune system, which can permit for reactivation of neurotrophic pathogens corresponding to viruses within the herpes household.”
Virios’ lead antiviral improvement candidate, orally administered IMC-1, is a novel, proprietary, fastened dose, antiviral remedy combining famciclovir and celecoxib. The continuing Section 2b FORTRESS research is a randomized, double-blind analysis of IMC-1 in sufferers with FM. The FORTRESS research builds on the statistically important outcomes from the Firm’s beforehand accomplished Section 2a FM scientific research. The 143-patient Section 2a trial demonstrated that IMC-1 met its main endpoint of ache discount and was statistically higher tolerated than placebo.
The Firm’s twin mechanism antiviral improvement candidates are designed to synergistically suppress herpes virus activation and replication. The individuality of this method has garnered IMC-1 “quick observe” designation by the U.S. Meals and Drug Administration (“FDA”), the primary of its type for a brand new FM improvement candidate.
About IMC-1 and IMC-2
IMC-1 is a novel, proprietary, fastened dose mixture of famciclovir and celecoxib. This twin mechanism antiviral remedy is designed to synergistically suppress herpes virus activation and replication. IMC-1 combines two particular mechanisms of motion purposely chosen to inhibit herpes virus activation and replication, thereby retaining herpes viruses in a latent (dormant) state or “down-regulating” herpes viruses from a lytic (lively) state again to latency. The famciclovir part of IMC-1 inhibits viral DNA polymerase mandatory for replication. The celecoxib part of IMC-1 inhibits each cyclooxegenase-2 (“COX-2”) and COX-1 enzymes, utilized by herpes viruses to speed up their replication.
IMC-2 is a novel, proprietary mixture of valacyclovir and celecoxib that mixes two particular and synergistic mechanisms of motion, purposely chosen to inhibit herpes virus activation and replication. IMC-2 retains herpes viruses in a latent (dormant) state or “down-regulates” herpes viruses from a lytic (lively) state again to latency. The valacyclovir part of IMC-2 inhibits viral DNA polymerase mandatory for replication. The celecoxib part of IMC-2 inhibits each COX-2 and COX-1 enzymes, utilized by herpes viruses to speed up their replication.
About Virios Therapeutics
Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology firm targeted on advancing novel antiviral therapies to deal with debilitating persistent ailments, corresponding to FM. Immune responses associated to the activation of tissue resident herpes have been postulated as a possible root trigger triggering and/or sustaining persistent diseases corresponding to FM, irritable bowel illness (“IBS”), persistent fatigue syndrome and different practical somatic syndromes, all of that are characterised by waxing and waning signs with no apparent etiology. Our lead improvement candidate (“IMC-1”) is a novel, proprietary, fastened dose mixture of famciclovir and celecoxib designed to synergistically suppress herpes replication, with the tip objective of decreasing virally promoted illness signs. Proof of IMC-1’s efficacy on a broad spectrum of FM end result measures was beforehand demonstrated in a Section 2a scientific trial.
Virios Therapeutics, Inc. is offering BHC with an unrestricted grant to discover the therapeutic potential of mixture antiviral remedy with the Firm’s second improvement candidate, IMC-2, in managing the fatigue, sleep, consideration, ache, autonomic operate and anxiousness related to Lengthy COVID.
The Firm is led by an govt group extremely skilled within the profitable improvement and commercialization of novel therapies.
For extra info, please go to www.virios.com.
Comply with Virios Therapeutics
About Bateman Horne Middle of Excellence
The Bateman Horne Middle (“BHC”) is a non-profit, interdisciplinary Middle of Excellence the place scientific care, analysis, and training meet to collectively advance the analysis and remedy of myalgic encephalomyelitis/persistent fatigue syndrome (“ME/CFS”), fibromyalgia (“FM”), post-viral syndromes, and associated comorbidities.
BHC fosters scientific success for the care and remedy of ME/CFS and FM utilizing scientific intelligence derived from knowledge analytics of affected person data within the quest for improved medical take care of present and future sufferers.
BHC engages collaborative partnerships to tell healthcare customers and suppliers to ship enhanced high quality and improved outcomes by means of innovation, utilized know-how, and environment friendly distribution of information.
Statements on this press launch comprise “forward-looking statements”, inside the that means of the U.S. Personal Securities Litigation Reform Act of 1995, which might be topic to substantial dangers and uncertainties. All statements, aside from statements of historic reality, contained on this press launch are forward-looking statements. Ahead-looking statements contained on this press launch could also be recognized by way of phrases corresponding to “anticipate,” “consider,” “ponder,” “might,” “estimate,” “count on,” “intend,” “search,” “might,” “may,” “plan,” “potential,” “predict,” “venture,” “counsel,” “goal,” “goal,” “ought to,” “will,” “would,” or the unfavourable of those phrases or different related expressions, though not all forward-looking statements comprise these phrases. Ahead-looking statements are primarily based on Virios Therapeutics’ present expectations and are topic to inherent uncertainties, dangers and assumptions which might be troublesome to foretell, together with dangers associated to the completion and timing of any research referring to the remedy of Lengthy COVID with IMC-2. Additional, sure forward-looking statements are primarily based on assumptions as to future occasions that will not show to be correct. These and different dangers and uncertainties are described extra absolutely within the part titled “Danger Elements” within the Annual Report on Kind 10-Okay for the yr ended December 31, 2020 filed with the Securities and Change Fee. Ahead-looking statements contained on this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no obligation to replace such info besides as required beneath relevant regulation.
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