Virios Therapeutics Granted New Patent for Antiviral Inhibitor Combination

Rhea-AI Summary

Virios Therapeutics (Nasdaq: VIRI) has secured patent exclusivity for its valacyclovir-celecoxib combination drug until 2033, enhancing its intellectual property portfolio to 21 patents. The company’s lead candidate, IMC-1, targets fibromyalgia and is currently in a Phase 2b trial (FORTRESS) following promising Phase 2a results. Virios is also exploring new antiviral therapies as it aims to address chronic diseases linked to HSV-1 activation. The CEO expressed optimism about their expanding therapeutic focus.

Positive

• Patent exclusivity for valacyclovir-celecoxib combination until 2033.
• Total of 21 issued patents enhances competitive edge.
• Lead candidate IMC-1 shows promise in Phase 2a trials for fibromyalgia.
• IMC-1 has received fast track designation from the FDA.

Negative

• None.

Intellectual Property Estate Now Includes Valacyclovir-Celecoxib Combination

ATLANTA--(BUSINESS WIRE)-- Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, announced today that the United States Patent and Trademark Office (“USPTO”) has granted Virios Therapeutics patent exclusivity on its valacyclovir-celecoxib combination drug candidate to 2033. The Company’s intellectual property portfolio now includes 21 issued patents, consisting of 13 issued U.S. patents and 8 issued foreign patents, with exclusivity into 2033. This portfolio of patents also covers the Company’s lead development candidate IMC-1, a synergistic, fixed dose combination of famciclovir and celecoxib, which is in Phase 2b development for the treatment of fibromyalgia.

“We are pleased to expand our substantial intellectual property portfolio with a new patent for an additional proprietary antiviral combination therapy,” stated Greg Duncan, Chairman and Chief Executive Officer. “In the context of increasing recognition in the scientific community of the potential role of activated viruses in triggering a wide range of conditions, Virios is actively exploring new disease targets as a complement to our ongoing fibromyalgia Phase 2b program.”

About Virios Therapeutics

Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel syndrome (“IBS”), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 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. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial (“FORTRESS”) designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

Forward-Looking Statements

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” "will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Virios Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion and timing of the Phase 2b trial. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210908005139/en/

Dave Gentry

1-800-733-2447

+1-407-491-4498

dave@redchip.com

or

ir@virios.com

Source: Virios Therapeutics, Inc.

FAQ

What is the significance of the patent granted to Virios Therapeutics for VIRI?

The patent grants Virios exclusivity for its valacyclovir-celecoxib combination until 2033, strengthening its intellectual property.

Which clinical trial is Virios Therapeutics currently conducting for VIRI?

Virios is conducting a Phase 2b trial named FORTRESS for its lead drug candidate, IMC-1, aimed at treating fibromyalgia.

What are the future plans for Virios Therapeutics' drug candidates?

Virios plans to explore additional antiviral therapies alongside its ongoing development of IMC-1.

How many patents does Virios Therapeutics hold now?

Virios Therapeutics currently holds a total of 21 issued patents.

What was the outcome of the previous Phase 2a trial for IMC-1?

The Phase 2a trial for IMC-1 demonstrated promising results across a broad spectrum of fibromyalgia outcome measures.