Anivive Repurposes Veterinary Drug GC376 for COVID-19 And Submits Pre-IND to FDA

GC376 was safe and effective in 4 animal models of coronaviral infections. Strong antiviral activity against SARS-CoV-2 and immediate manufacturing capabilities make protease inhibitor GC376 a potential candidate for the treatment of COVID-19 in humans.

LONG BEACH, Calif.--(BUSINESS WIRE)-- Anivive Lifesciences, a biotechnology company focused on developing first-in-class therapeutics for veterinary patients, has filed a pre-Investigational New Drug (pIND) request with the Food and Drug Administration for GC376, a candidate for the treatment of COVID-19 in humans.

“Published data shows that GC376 demonstrates in vitro and in vivo activity against many animal and human coronaviruses including SARS, MERS and most recently SARS-CoV-2,” explains Anivive Chief Medical Officer David Bruyette, DVM, DACVIM. “GC376 has shown strong activity against both the main protease (3CLpro) as well as SARS-CoV-2 in cell lines and has a CC₅₀ of > 200 resulting in a high therapeutic index”.

Since 2018 Anivive has been developing GC376 to treat the leading cause of death in kittens and young cats, Feline Infectious Peritonitis (FIP), a disease caused by a coronavirus. GC376 was identified as a promising therapeutic candidate by AniviveSELECT, Anivive’s AI-powered software that accelerates the drug discovery process by analyzing and learning from a massive collection of drug data compiled from over 300 sources.

“We look forward to our discussions with the FDA and advancing toward a clinical trial,” says Anivive CEO and Founder Dylan Balsz. “Our research over the past few months and our experience with GC376 support the exploration of the drug as an adjunct therapy to standard of care for COVID-19 patients or for patients where standard of care may be contraindicated.”

GC376 is a protease inhibitor. Like all coronaviruses, FIP and SARS-CoV-2 contain a protease which is responsible for replication of the virus. GC376 successfully blocks the replication process. Internal and third-party research suggests that GC376 is also highly active against the protease in SARS-CoV-2, 3CLpro, that causes COVID-19. Prior to the COVID-19 pandemic, Anivive was working with their existing GMP manufacturers to meet regulatory requirements and have since accelerated production to provide GC376 for human clinical trials.

Anivive remains dedicated to developing GC376 for veterinary patients but, given the current pandemic and scarcity of effective therapies, is also exploring the use of GC376 in humans to help combat COVID-19.

The FDA will guide Anivive on the proposed clinical study protocol. Anivive then plans to submit an IND application for GC376 to be evaluated as a potential addition to the current standard of care treatment for COVID-19.

About GC376

GC376 is a novel, first-in-class, small molecule protease inhibitor with a favorable therapeutic index demonstrated in preclinical studies. A common feature of viruses in the picornavirus-like supercluster (including coronaviruses) is a 3C or 3C-like protease (3Cpro or 3CLpro, respectively) responsible for viral replication. Viruses in this family include human coronavirus 229E, transmissible gastroenteritis virus of swine (TGEV), murine hepatitis virus (MHV), bovine coronavirus (BCV), feline infectious peritonitis virus (FIPV), severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East Respiratory Syndrome (MERS) and COVID-19 (SARS-CoV-2). GC376 has been shown to be a potent inhibitor of this protease across all coronaviruses with a high therapeutic index.

About Anivive Lifesciences

Anivive is a next-generation pet health drug discovery and commercialization company that dramatically improves the speed and cost of addressing unmet medical needs in pets. Using a novel technology and analytics platform, Anivive discovers first-in-class therapeutics for unmet conditions in pets. Anivive has in-licensed the global development and commercialization rights to 5 mid/late stage product candidates and holds exclusive rights to several others. Anivive is currently seeking FDA conditional approval for verdinexor (a canine lymphoma investigational therapeutic) and USDA conditional license for canine Valley Fever investigational vaccine. More than 1,000,000 dogs succumb to canine lymphoma annually and there are over 30,000,000 dogs at risk for Valley Fever in the U.S.

Anivive continues to develop a mid-stage therapeutic for feline infectious peritonitis (FIP). FIP is caused by a feline coronavirus that kills 700,000 cats annually. FIP is fatal within a matter of weeks and has no approved treatments. Anivive has repurposed GC376 to help combat COVID-19 while maintaining their commitment to bring the product to the veterinary market. For more information please visit: www.anivive.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Anivive Lifesciences expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Anivive or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Anivive with press releases or oral statements made by or with the approval of one of Anivive’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Anivive’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Anivive’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the recent outbreak of coronavirus; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry. Anivive does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200526005874/en/