Anivive Initiates Two Pre-Clinical Studies of Investigational Antiviral GC376 for the Treatment of COVID-19

-- Current Milestones Indicate Phase 1 Human Trials Could Begin by the end of 2020 --

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Jul 01, 2020, 18:33 ET

LONG BEACH, Calif., July 1, 2020 /PRNewswire/ -- Anivive Lifesciences, a biotechnology company focused on developing first-in-class therapies, today announced the initiation of two pre-clinical studies to further evaluate the in vivo efficacy and safety of GC376 as a treatment for COVID-19.

"We are pleased with the progress of this program investigating the therapeutic potential of GC376 as both a treatment for COVID-19 and other coronavirus related diseases," explained Dylan Balsz, Anivive's CEO & Founder

Chief Medical Officer David Bruyette, DVM, DACVIM emphasized Anivive's commitment to developing GC376 as a treatment for both humans and animals, saying, "We continue to honor the needs of our veterinary patients but, given the current pandemic and scarcity of effective therapies, we feel compelled to do whatever we can to help combat COVID-19."

Anivive previously announced it filed a pre-Investigational New Drug (pIND) request for GC376 with the Food and Drug Administration (FDA) earlier this year to advance the program for use in humans. The company licensed the exclusive worldwide rights to GC376 from Kansas State University for use as a treatment in both humans and animals.

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
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.

In addition to pursuing GC376 as a treatment for COVID-19, Anivive continues to develop it as a treatment 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 its commitment to bring the product to the veterinary market. To learn more 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.

SOURCE Anivive Lifesciences Inc.