Effectiveness Submission to the FDA-CVM on Track for 2Q 2016.
DUBLIN, Ireland, March 08, 2016 (GLOBE NEWSWIRE) –Link here.
Nexvet Biopharma (Nasdaq:NVET), a veterinary biologics developer, today announced the successful completion of its pilot field study for ranevetmab* (NV-01), the Company’s anti-nerve growth factor (NGF) monoclonal antibody (mAb) therapy in development for the control of pain associated with osteoarthritis in dogs.
This pilot field study was initiated in the second quarter of 2015 to evaluate a combination of doses and routes of administration to complement the pivotal safety and efficacy study for ranevetmab. In November 2015, Nexvet announced that the completed pivotal study demonstrated ranevetmab’s safety and efficacy (p≤ 0.038 for the primary endpoint) when administered by subcutaneous (SC) injection once a month for three months. Results from this most recent pilot study confirmed ranevetmab’s safety and efficacy in a field study evaluating a range of dosages and treatment regimens (SC and intravenous administration) in an additional population of 176 dogs.
“Ranevetmab has been evaluated in 422 dogs with osteoarthritis in the pivotal and pilot studies and has shown clinically meaningful efficacy and an attractive safety profile. These results reaffirm our belief that ranevetmab’s unique target product profile will make it a first-in-class and best-in-class therapeutic for the management of chronic pain associated with osteoarthritis in dogs,” said Dr. Mark Heffernan, Nexvet’s Chief Executive Officer.
Nexvet is on track to submit the technical effectiveness section of the NV-01 dossier to the FDA’s Center for Veterinary Medicine (CVM) in the second calendar quarter of 2016, including the safety data from this most recent study.
About Nexvet (www.nexvet.com)
Nexvet is a veterinary biologics developer 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 also 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 is growing its biomanufacturing capabilities in Ireland.
*The United States Adopted Name (USAN) Council has approved the generic name “ranevetmab” for NV-01.
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