Virios Therapeutics, (Formerly Innovative Med Concepts)
Builds Out Leadership Team to Scale Capital and Prepare
to Execute Landmark IMC-1 Phase 2b Fibromyalgia Program
Atlanta - April 5, 2020
The Innovative Med Concepts (IMC) Board of Directors approved the appointment of Greg Duncan as the Chief Executive Officer. Mr. Duncan has been on the IMC Board of Directors and is well known by IMC and its investors. Greg has held executive positions in both public and private life-science companies at Pfizer, UCB and Celtaxsys. Prior to joining IMC, Mr. Duncan was President and Chief Executive Officer of Celtaxsys, Inc., a privately held biotech company focused on developing anti-inflammatory medicines for rare diseases. In this role, he scaled the required capital to build out organizational capability and to advance both pre-clinical and clinical development candidates. Before joining Celtaxsys, Mr. Duncan served as an Executive Committee member at Belgium based UCB, a $4B specialty pharma entity developing and commercializing medicines for immunologic and central nervous system disorders . Before joining UCB, Greg spent 17 years with Pfizer, where he held a number of executive U.S. and international positions, including President of Pfizer’s $2B Latin America Operations and SVP in Pfizer USA, Pfizer’s largest operational unit. His operational teams had accountability for the launches of many “blockbuster” pharmaceutical brands including Lipitor, Zoloft, Viagra, Celebrex, Aricept, Lyrica, Cimzia, Zithromax (ZPack), Diflucan, Sutent, Rebif and Vimpat.
Two other key executives from Celtaxsys will join IMC. Angela Walsh has been appointed VP of Finance and Corporate Treasurer. Mrs. Walsh has over three decades of experience in the field of financial management and accounting, specializing in mergers and acquisitions, strategic planning, compliance and risk management, as well as financial modeling, budgeting, and forecasting. Prior to IMC, she was the VP of Finance for Celtaxsys, Inc., where she oversaw and managed the company’s financial and accounting activities. Previous to Celtaxsys, Mrs. Walsh was the CFO for Green Circle Bio Energy and was part of the executive team that executed a successful acquisition by Enviva Partners, LP, which subsequently executed a $214M IPO. Mrs. Walsh has also served as the Controller for Huffy Sports, a division of the Russell Corporation and participated in numerous capital market transactions including mergers and acquisitions, debt offerings and filing S-1s for initial public offerings. Mrs. Walsh began her accounting career with Arthur Anderson and is a Certified Public Accountant in both Georgia and North Carolina.
Additionally, Ralph Grosswald will join IMC as VP of Operations. Ralph brings 25 years of experience developing innovative drugs and medical devices to the IMC leadership team. Previously, Mr. Grosswald was a founder and Vice President of Operations at Celtaxsys, Inc. where he managed operations, nonclinical development and clinical trials of acebilustat for the treatment of cystic fibrosis. Prior to that, Mr. Grosswald started GMP Companies, Inc. where he managed development programs of the first ever Microinvasive Glaucoma Shunt and the LifeSync Wireless ECG. Before joining GMP, he was the Director of Outcomes Research for the National Healthcare Network, a cardiovascular centers of excellence managed care network partnered with the Duke Clinical Research Institute. Mr. Grosswald began his career as a clinical trial coordinator for both interventional cardiology and cardiothoracic surgery studies at the Emory University School of Medicine.
A message from Greg Duncan: I am excited to join IMC as Chief Executive Officer. I have served on the board of directors since it was formed several years ago, and the team looks forward to hitting the ground running at full speed to raise the capital required to finance our landmark, IMC-1 Phase 2b fibromyalgia program. I am excited to be bringing two key executives from Celtaxsys to IMC, Ralph Grosswald, VP of Operations and Angela Walsh, VP of Finance, Corporate Treasurer. Angela, Ralph and I have worked together for many years, allowing us to quickly execute and advance IMC’s objectives. The company is in an enviable position with very strong clinical data supporting IMC-1’s novel potential to treat fibromyalgia, a strong foundation of IP and patent protection and, presuming continued development success, a large commercial opportunity associated with upgrading the standard of care for the millions of patients suffering from fibromyalgia.
I am personally grateful to Dr. Skip Pridgen and Rick Burch for the excellent work they have done in shepherding IMC through the early stages of development. Dr. Pridgen, who you know founded IMC, has created something truly unique, extremely valuable, and critically needed by patients across the globe. Mr. Burch has successfully transformed the company using quality and professionalism that is associated with respected big pharma companies. Their experience and input will remain invaluable to the company going forward.
About Innovative Med Concepts: IMC is a privately held development stage biotech company that has 9 compounds in its pipeline, treating a wide range of related conditions. The company’s breakthrough scientific discovery identifies a viral triggered immune response that results in fibromyalgia. The FDA confirmed fibromyalgia is a serious disease with a major unmet medical need. The agency awarded IMC-1, a novel fixed-dose combination oral medication designed to treat chronic tissue-resident herpes simplex virus type 1 (HSV-1) with Fast Track status due to the potential to meet this need with a novel mechanism of action designed to address the underlying cause of fibromyalgia. In addition to Fibromyalgia, Innovative Med Concepts, is also developing novel treatments for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), irritable bowel syndrome and other related conditions.
A fibromyalgia combination treatment Phase 2a Study published in JPR >
Infections and other stressors have been implicated in the development of Fibromyalgia. We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. The study evaluated a famciclovir + celecoxib drug combination (IMC-1), active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia.
Virios Therapeutics (Formerly Innovative Med Concepts) Announces Receipt of FDA Fast Track Designation for IMC-1,
a Novel Treatment for Fibromyalgia
TUSCALOOSA, Ala., Jan. 28, 2016 /PRNewswire/
Innovative Med Concepts, LLC, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the development of IMC-1 for the treatment of fibromyalgia. IMC-1 previously completed a randomized, double-blinded, placebo controlled Phase II study (PRID-201), showing that IMC-1 appears to have promise treating the pain and other symptoms of fibromyalgia.
William Pridgen, M.D., Founder and CEO of Innovative Med Concepts, stated, "We are pleased that the FDA has granted Fast Track status to IMC-1, as it demonstrates their recognition of this condition as a significant unmet medical need. IMC-1 has a novel mechanism of action designed to suppress chronic tissue-resident herpes virus, which may have a role in triggering or maintaining symptoms of fibromyalgia. IMC-1 is a fixed-dose combination using proprietary doses of famciclovir, an anti-viral nucleoside analog, and celecoxib, a COX-2 inhibitor that also possesses unique anti-viral activity. Suppressing latent herpes viruses may significantly improve fibromyalgia related symptoms. We are currently meeting the development requirements to begin Phase III trials with IMC-1 in 2017."
Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases. In order to receive Fast Track designation, a product must demonstrate the potential to address an unmet medical need in a serious condition. Companies granted Fast Track designation benefit from greater access to, and more frequent communications with, the FDA throughout the drug development or review process and are allowed to submit New Drug Applications (NDA) on a rolling basis. In addition, Fast Track designation products are eligible for potential accelerated approval and priority review.
Fibromyalgia is a debilitating disorder involving widespread chronic pain along with other symptoms of fatigue, headaches, sleep problems, mood changes and inability to concentrate. According to the National Fibromyalgia Association, an estimated 3-6 percent of people worldwide suffer from the condition, or approximately 10 million in
the United States and 220 million worldwide.
About Virios Therapeutics
Virios Therapeutics, LLC, is a biotech company developing novel treatments for fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), irritable bowel syndrome and other related conditions.
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