Virios Therapeutics Stock

Virios Therapeutics, Inc., a development-stage biotechnology company, focuses on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response, such as fibromyalgia (FM).

The company's lead candidate, IMC-1, is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. IMC-1 represents a novel combination, dual mechanism antiviral therapy designed to synergistically suppress herpes virus activation and replication, with the end goal of reducing viral mediated disease burden.

IMC-1 combines two specific mechanisms of action purposely designed to inhibit herpes virus activation and replication, thereby keeping the herpes virus in a latent (dormant) state or down-regulating the virus from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA replication. The celecoxib component of IMC-1 inhibits cyclooxegenase-2 (COX-2) and to a lesser degree COX-1 enzymes, used by the herpes virus to amplify or accelerate its own replication.

IMC-1 also exhibited consistent improvement across several secondary FM treatment outcomes, including 50% responder analysis, improved functional assessments, lower chronic fatigue, increased time to rescue medication and improvements in FM patient's overall global health status. One key secondary measure assessing a 30% pain reduction analysis was approaching but did not meet statistical significance (p = 0.052). In the Phase 2a study, IMC-1 demonstrated a lower discontinuation rate due to adverse events as compared with placebo.

Based on the significant unmet need in treating FM and the aforementioned Phase 2a FM data, IMC-1 has been granted FDA designation for fast-track review status. In addition, the novel mechanism of IMC-1 has enabled the company to secure composition of matter intellectual property (patent) protection to 2033.

Following on from its successful Phase 2a study, the company held an end of Phase 2 meeting with the FDA. In the meeting, the company agreed to initiate either a Phase 2b study or a Phase 3 program after it provides animal toxicology study data, to conduct a human PK study and a clinical trial protocol that includes monitoring renal function through standard safety labs to the U.S. Food and Drug Administration (FDA). A human PK study with the combined tablet of IMC-1 was completed and performed as expected, with no drug-drug interactions and no adverse events. Multiple dose PK of IMC-1 was well characterized and provides additional data to better understand the PK profile of IMC-1. As a result, the company has progressed development of IMC-1 from Phase 2a proof-of-concept to a larger scale Phase 2b study, known as FORTRESS, (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), for the treatment of FM. The Phase 2b and chronic toxicology studies are planned components of the registration package supporting Phase 3 requirements.

The PRID-201 study represents the first placebo-controlled study evaluating the safety and efficacy of IMC-1. The Phase 2a clinical study involved 143 FM patients and a 16 -week, multicenter, double blind, randomized, placebo-controlled, Phase 2a proof of concept trial conducted under IND 114827.

In May 2021, the company began screening patients in its Phase 2b study known as the FORTRESS study (an abbreviation that stands for Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Virus) and in June 2021, the company announced the dosing of its first patient in the FORTRESS study. A complete description of the study, including secondary and exploratory objectives, and results can be found in the PRID-202 Clinical Study Report that will be submitted to the Investigational New Drug (IND) in Q2 of 2023. The company has regularly engaged the FDA on IMC-1 for the treatment of FM.

In September 2022, the company announced the top line results from its FORTRESS Phase 2b FM study. The safety and efficacy results from the FORTRESS study support progression of IMC-1 to Phase 3 development for new patients, who represent the vast majority of the FM patient community. The company is scheduled to meet with the FDA in March 2023 to discuss advancing IMC-1 into Phase 3 development as a treatment for FM.

For the Phase 3 program, the company intends to run two qualifying pivotal trials demonstrating the safety and efficacy of IMC-1 treating patients with FM. The first Phase 3 study is planned to be a four-arm, multifactorial design to demonstrate the relative safety and efficacy of IMC-1 as compared to celecoxib alone, famciclovir alone and placebo. The second Phase 3 study is planned to be a two-arm study comparing IMC-1 to placebo. All patients from the Phase 3 program will be offered the opportunity to enroll into an open label safety follow-on extension study in which all patients will be treated with IMC-1, which is the third key component of the Phase 3 program proposal.

The company provided the Bateman Horne Center (BHC) with an unrestricted grant for an investigator-sponsored study to explore the therapeutic potential of combination antiviral therapy with Virios' second development candidate, IMC-2, a combination of valacyclovir and celecoxib. The study is evaluating changes in common Long-COVID symptoms, such as fatigue, sleep, attention, pain, autonomic function and anxiety and commenced dosing in the third quarter of 2022. The study is fully enrolled with data expected in mid-2023.

Intellectual Property

As of December 31, 2022, the company's portfolio of owned patents totaled 21 issued patents in the United States and abroad. This includes three Composition of Matter patents, including a Synergistic Patent, and two Method of Use patents in the United States, all of which relate to IMC-1. Exclusivity with all patents extends to 2033.

Issued U.S. IMC-1 Patents: U.S. Composition of Matter Patents (US 8,809,351 & US 10,034,846) Drug-combination of famciclovir and celecoxib; U.S. Method-of-Use Patent (US 9,040,546) Famciclovir + celecoxib for the treatment of FM (fibromyalgia), CFS or IBS; U.S. Method-of-Use Patent (US 9,173,863) Method of dispensing famciclovir + celecoxib in a regimen to treat Functional Somatic Syndrome conditions; and U.S. Composition of Matter Synergistic Patent (US 10,251,853) Synergistic combination for total daily dose of famciclovir and celecoxib.

Issued Foreign IMC-1 Patents: European Patent (EP 2 811 833 & 2 965 759 - validated in 18 countries); Japan (JP 5855770 & 6422848); Australia (AU 2013217110); China (CN 104144606); Korea (KR 10-1485748); and Canada (2,863,812).

The U.S. Patents Covering Other Anti-Viral Combinations: U.S. 9,682,051 (acyclovir/meloxicam); U.S. 8,623,882 (acyclovir/diclofenac); U.S. 9,259,405 (famciclovir/diclofenac); U.S. 9,642,824 (valacyclovir/diclofenac); U.S. 9,980,932 (valacyclovir/meloxicam); U.S. 10,543,184 (acyclovir/celecoxib); U.S. 10,632,087 (famciclovir/meloxicam); and U.S. 11,096,912 (valacyclovir/celecoxib).

The company has also been granted additional U.S. and EU patents, representing all possible combinations of targeted antivirals and non-steroidal anti-inflammatory drugs (NSAIDs/COX-2s) containing appropriate COX-2 & COX-1 inhibition. The company is developing only IMC-1 (famciclovir/celecoxib) with the other patents being obtained to increase the therapeutic combinations that it may explore in the future to treat other virally medicated illnesses.

Agreements

In 2012, the company entered into a Know-How License Agreement (the License Agreement) with the University of Alabama. In consideration for the License Agreement, the University of Alabama received membership interests in the company representing 10% of the issued membership interests at that time. The License Agreement is in effect for 25 years and will terminate on June 1, 2037. Under the License Agreement, the company was granted a non-exclusive, worldwide, royalty-free license to utilize, including the right to sublicense and sell products incorporating, the know-how, technical information, and data related and pertaining to the herpesvirus biology, including herpesvirus replication mechanisms, modes of action of anti-herpesvirus medications, and sensitivity and accuracy of herpesvirus diagnostic tests, any of which were developed by the University of Alabama. The University of Alabama reserved the right to use the Technical Information for educational, research, clinical, and other non-commercial purposes. The company may assign the license to any purchaser or transferee of substantially all of its assets.

Sales and Marketing

If IMC-1 is approved, the company plans to enter into sales and marketing agreements with one or several pharmaceutical companies to sell to neurologists, geriatric specialists and to primary care physicians.

Research and Development

The company's research and development expenses were $8.1 million for the year ended December 31, 2022.

Government Regulation

The FDA and comparable regulatory authorities in state and local jurisdictions and in other countries impose substantial and burdensome requirements upon companies involved in the clinical development, manufacture, marketing and distribution of drugs, such as those the company is developing.

History

Virios Therapeutics, Inc. was founded in 2012. The company was incorporated in 2020. The company was formerly known as Virios Therapeutics, LLC and changed its name to Virios Therapeutics, Inc. in December 2020.