Monepantel is an oral aminoacetonitrile compound that inhibits the mTOR pathway which is a key driver of cancer. PharmAust is evaluating monepantel for treatment of lymphomas and other cancers in dogs.
The Current Treatment Landscape
B-Cell Lymphoma is an aggressive form of canine cancer with a poor prognosis – without treatment it is often fatal within weeks of diagnosis. An estimated 6 million dogs are diagnosed with cancer each year in the US alone, with B-Cell Lymphoma being the most common histologic subtype.
The current standard of care treatment is multiagent chemotherapy with CHOP (cyclophosphamide, hydroxydaunorubicin, vincristine and prednisone) the most frequently adopted protocol. While CHOP has a high response rate, it has significant side effects ranging from gastrointestinal disturbance to bone marrow suppression. Chemotherapy is a high-cost treatment with poor quality of life outcomes, and poses major safety risk to owners handling pets.
Monepantel for the treatment of canine B-Cell Lymphoma is administered as an oral tablet at home. Pharmaust has completed Phase 2 monepantel studies with positive top-line data. The Phase 2 study was designed to determine a clinically safe and efficacious dosing regimen. Results demonstrate a positive overall clinical benefit and compare favourably to a recently approved US FDA B-Cell and T-Cell Lymphoma therapy.
The Phase 2 study added to monepantel’s safety profile established in a Phase 1 study with minimal side effects and no reported adverse events. Significantly, monepantel consistently demonstrates a significant competitive advantage in quality of life (QoL) and level of function (LoF) when compared to existing treatments.
Following promising Phase 2 results, PharmAust is preparing to initiate a field trial for product registration.
Attractive Commercial Opportunity
The global market for veterinary medical products is more than $22 billion per annum. Increasing dog numbers (estimated 90 million current US dogs) and expenditure on pets, considered ‘part of the family’, is driving market growth. According to the American Pet Products Association, in 2015 almost 80 percent of all dog owners had their dogs treated with drugs, compared to about 50 percent in 1998.
An estimated 6 million dogs are diagnosed with cancer each year in the US compared to 1.7 million humans. Many of the most common cancers in dogs (eg. lymphoma, osteosarcoma, mammary) are recognised as being very similar to human cancers. As such, dogs are increasingly used as models for human disease.
PharmAust has shown that monepantel is a cost-effective, safe and potent therapy which meets the unique combination of criteria required to generate a commercial return in the companion animal drug market.