Nexvet Announces Initiation of Pivotal Efficacy St

DUBLIN, Ireland, Dec. 12, 2016 (GLOBE NEWSWIRE) -- Nexvet Biopharma (Nasdaq: NVET ) today announced it has initiated a pivotal field efficacy and safety study of frunevetmab, the Company’s anti-nerve growth factor (NGF) monoclonal antibody (mAb) therapy which is being developed as a monthly subcutaneous injectable for the control of pain associated with osteoarthritis in cats. Nexvet expects to report data from both this study and a currently running pivotal target animal safety study of frunevetmab in the fourth quarter of calendar 2017.

The pivotal field efficacy and safety study will be a placebo-controlled, randomized, double-blinded study with a target enrolment of 250 cats with osteoarthritis at approximately 20 clinical sites around the United States. Enrolled cats will be randomly assigned to receive frunevetmab or placebo at a 2:1 ratio. Each cat will receive three doses, with each dose given 28 days apart. This study has received protocol concurrence from the Center for Veterinary Medicine at the United States Food and Drug Administration and will utilize owner-assessed responses to treatment as its primary endpoint.

“Frunevetmab’s successful proof-of-concept and pilot studies, as well as market research, strongly support our investment in this pivotal study. We are excited to be advancing a potential first-in-class product in chronic cat pain, as it is a major indication under-served by current therapeutic options. In the United States, for example, there are currently no pain medications approved for use in cats for longer than three consecutive days, despite studies indicating that a majority of cats show signs of degenerative joint disease, including osteoarthritis,” commented Dr. Mark Heffernan, Chief Executive Officer of Nexvet.

“We therefore see a significant opportunity in opening up chronic cat pain to a new class of therapeutic. We believe a historic parallel can be seen when non-steroidal anti-inflammatory drugs (NSAIDs) were introduced to the market in the late 1990s to manage chronic canine pain. This began a dramatic expansion of the U.S. market for companion animal pain management products, predominantly for dogs, from under $10 million to approximately $280 million today,” concluded Dr. Heffernan.

In May 2016, Nexvet announced the successful completion of a randomized, placebo-controlled pilot field study of frunevetmab which enrolled 126 cats with naturally occurring osteoarthritis. This study demonstrated statistically significant improvements over placebo at multiple endpoints and informed the endpoint design of the pivotal field efficacy and safety study. No significant adverse safety signals were observed in the study.

About Nexvet ( www.nexvet.com )

Nexvet is a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization™ platform is designed to rapidly design monoclonal antibodies (mAbs) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost.

Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, which conducts drug discovery in Australia, conducts clinical development in the United States and Europe and conducts biomanufacturing in Ireland.

Forward looking statements

This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, ability to access financing on acceptable terms or at all, results of any current or future pivotal study, future expenditures relating to our lead product candidates, time for completion of any of our studies or facilities upgrades, ability to develop our pipeline of product candidates, business strategy, prospective products, ability to successfully manufacture our own product candidates, ability to meet conditions for the receipt of government grants, time for regulatory submissions or ability to qualify for conditional licensure or obtain product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products.  These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward looking statements.  The words “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “position,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward looking statements, although not all forward looking statements contain these identifying words.  These forward looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors.

Factors that could cause actual results to differ materially from our expectations expressed in this report include those summarized under Risk Factors in our reports on Forms 10-Q and 10-K and the other documents we file from time to time with the Securities and Exchange Commission.  Given these risks and uncertainties, you should not place undue reliance on these forward looking statements.  Also, forward looking statements represent management’s beliefs and assumptions only as of the date of this press release.  Except as required by law, we do not intend, and undertake no obligation, to revise or update these forward looking statements or to update the reasons actual results could differ materially from those anticipated in these forward looking statements, even if new information becomes available in the future.

Further information: Investors                                                                       Candice Knoll                                                                 Blueprint Life Science Group                                         +1 415-375-3340 Ext. 4                                                                      cknoll@bplifescience.com                                             Media Jessica Burns Berry & Company Public Relations +1 212-253-8881 jburns@berrypr.com