Nexvet To Present Key Data On Use Of Species-Specific Monoclonal Antibodies In Management Of Chronic Pain In Dogs

MELBOURNE, Australia, June 5, 2014 /PRNewswire/ -- Nexvet Biopharma, a leading veterinary biologic drug developer, today announced the oral presentation of data related to clinical development of NV-01, a novel canine monoclonal antibody (mAb) at a major upcoming veterinary meeting, the publication of a further peer-reviewed journal article regarding NV-01, and Nexvet's sponsorship of a pain management specialist veterinary meeting. 

1. NC State Clinician Scientist Duncan Lascelles, BSc, BVSc, PhD, CertVA, DSAS(ST), DECVS, DACVS, Professor of Small Animal Surgery and Pain Management at North Carolina State University College of Veterinary Medicine, will present results of a recent masked, placebo-controlled, proof-of-concept study evaluating the efficacy of NV-01, a novel caninised anti-NGF mAb in development for the treatment of degenerative joint disease-associated pain in dogs. The presentation, entitled "Efficacy of Canine Anti-Nerve Growth Factor Antibody for the Alleviation of Degenerative Joint Disease-Associated Pain in Dogs", will be given on Saturday, June 7, 2014 at the American College of Veterinary Internal Medicine meeting in Nashville, Tennessee. This talk was accepted as a late-breaking abstract, which can be read in full below.
2. Results of a separate Nexvet study using NV-01 in the treatment of pain in osteoarthritic dogs have been published in the peer-reviewed journal American Journal of Veterinary Research. In the publication, entitled "Canine Brief Pain Inventory scores for dogs with osteoarthritis before and after administration of a monoclonal antibody against nerve growth factor", treatment with a single injection of NV-01 was shown to significantly reduce the severity of pain and the degree to which pain interfered with activity in osteoarthritic dogs for at least four weeks. It also provided significant evidence for NV-01's improved half-life and safety over current standard-of-care medications (NSAIDs, or non-steroidal anti-inflammatory drugs).¹ This is the first peer-reviewed publication to demonstrate a 100% species-specific mAb delivering a significant therapeutic effect in a veterinary application.
3. As a leader in the discovery and development of 100% species-specific monoclonal antibodies in the treatment of pain in dogs and cats, Nexvet management will attend and co-sponsor the third International 2014 Veterinary Pain Short Course, held by the International Veterinary Academy of Pain Management (IVAPM) meeting, on June 20-22, 2014 in San Diego. This event assembles research leaders to discuss the latest findings across the field of pain management.

Professor David Gearing, Nexvet's chief scientific officer, said, "These important data presentations provide strong additional validation of the efficacy and safety of NV-01 in the treatment of pain in dogs and the potential of Nexvet's proprietary PETisation™ technology platform to develop new and better drugs for pain management and other unmet needs in companion animals."

The newly published paper presents the results of a trial overseen by Dr. Ralph Webster, a Nexvet collaborator. Dr. Webster said, "Osteoarthritis is a major problem in dogs, and we are increasingly recognising that a large proportion of the canine population is affected. Owners often misinterpret osteoarthritis as normal aging and thus do not appreciate the degree to which related pain can affect a dog's health and quality of life. Current standard-of-care drugs can be limited by their toxicity, inconvenience of administration, or limited effectiveness. NV-01 has the potential to represent a major advance in pain management for dogs in the years ahead."

Abstract of Dr Lascelle's presentation at ACVIM Forum 2014-05-28

TITLE: EFFICACY OF CANINE ANTI-NERVE GROWTH FACTOR ANTIBODY FOR THE ALLEVIATION OF DEGENERATIVE JOINT DISEASE-ASSOCIATED PAIN IN DOGS

BDX Lascelles^1,2, M Freire¹, D Knazovicky¹, B Case¹, K Jiamachello¹, D Gearing³

¹Comparative Pain Research Laboratory, ²Center for Comparative Medicine and Translational Research; NCSU CVM, Raleigh, NC. ³Nexvet, Melbourne, Australia

There is a critical need for proven drugs other than non-steroidal anti-inflammatory drugs for treatment of degenerative joint disease (DJD) pain in dogs. Antibodies against Nerve Growth Factor (NGF) are analgesic in rodent models and in humans with DJD. This pilot study aimed to evaluate the efficacy of a novel caninised anti-NGF antibody (NV-01) for the treatment of DJD pain in dogs.

In a placebo-controlled, masked clinical study, 26 dogs with DJD were randomized to NV-01 (200 mcg/kg IV) or placebo. In addition to objective accelerometry measures, owners completed clinical metrology instruments (Client-Specific Outcome Measures [CSOM] and Canine Brief Pain Inventory [CBPI]) on days 0, 14 and 28. CSOM and CBPI subscales (pain severity [PS] and pain interference [PI]) were evaluated within and between groups. Recognized success/failure criteria were applied and success compared between groups.

CBPI PS and PI scores significantly improved in the NV-01 group (PS: Day 0-14, P = .010 and Day 0-28, P = .025; PI: Day 0-14, P = .006 and Day 0-28, P = .032) but not in the placebo group. CSOM scores showed similar patterns with a significant difference between groups at day 14 and day 28 (P = .011 and P = .033, respectively), and significantly more successes at day 28 (P = .037). No side effects were noted. Objectively measured activity significantly increased in the NV-01 group (P = .045), not in the placebo group (P = .811).

These pilot data demonstrate a positive analgesic effect of anti-NGF antibody in dogs suffering from chronic pain. The magnitude of the effect was identical to that expected with an NSAID. 

About Nexvet (www.nexvet.com)
Nexvet is an unlisted company based in Melbourne, Australia, with global operations, partners and investors. The Company is pioneering the field of monoclonal antibody therapies for companion animals (e.g., dogs and cats) using its proprietary PETisation™ platform technology, which uniquely produces therapies 100% customised to target species.

In April 2014 Nexvet completed a US$31.5 million Series B financing led by a syndicate of major US healthcare investors, facilitating the expansion of Nexvet's clinical and scientific programs, as well as US expansion.

The Nexvet portfolio focuses on areas of greatest unmet medical need such as chronic pain and inflammatory diseases, in addition to a significant pipeline of medically important products. Monoclonal antibodies and other biologic drugs have become a massive growth area in human medicine, responsible for many of the most successful products on the market due to their clinical effectiveness, specificity and excellent side-effect profiles. Nexvet's clinical work is replicating these advantages in animal therapeutics.

Nexvet's team have international track records in the development of human biologics and veterinary medicines, and are committed to developing biologics to drive innovation in the $20 billion global veterinary pharmaceuticals market.

¹Webster et al. Am J Vet Res. June 2014; 75:532-535. The full article is viewable at this hyperlink.

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SOURCE Nexvet