The Phase 2 trial studying PharmAust’s lead drug monepantel (MPL) in dogs with B-cell lymphoma is expected to be completed by mid year.

PharmAust (ASX:PAA) says its Phase 2 trial for the treatment of canines with B-cell lymphoma with Monepantel (MPL)  is progressing well.

The latest results showed that two dogs had a partial response (>30% decrease in cancer tumour), and eight others have enjoyed a stable disease response.

Meanwhile one dog patient has surpassed 280 days with stable disease and continued excellent Quality of Life (QoL), as attested by dog owner testimonials.

The trial is being conducted at veterinary trial centres in Australia, New Zealand and the United States to evaluate the anti-cancer benefit of PAA’s lead drug Monepantel (MPL) tablets in dogs diagnosed with untreated B-cell lymphoma.

The combination of MPL with prednisolone has now demonstrated extended median survival to these pet dogs of 150 days, while maintaining their QoL.

PharmAust says assay results from 10 x plasma samples are expected by late May, while the MPL Phase 2 trial itself is expected to be completed by mid-2023.

Recruitment update

Since the last update at the beginning of March, the trial has recruited two more dogs – a Staffordshire bull terrier at the Perth Veterinary Services, and a shitzu at the Western Australian Veterinary Emergency and Specialty (WAVES).

The trial has also recruited an additional specialist oncology expert to the site, Dr Raelene Wouda, who recently joined the VSS (Veterinary Specialist Services) in Brisbane.

In addition, PharmAust has confirmed two new US sites for the trial –  one study site to be added in Austin and one in Dallas – with recruitment at these new US sites expected to commence in May.

The company says it requires eight of a further 19 dogs with stable disease progression to meet the Bayesian outcomes for a successful Phase 2 trial.

An outreach program to assist in recruitment has been launched, utilising social media platforms such as Facebook, LinkedIn and Twitter to drive awareness.

The company has also sent direct mail and emails to all vets within 40km radius of existing sites in Australia and NZ, as well as to all pet groomers and doggie day-care facilities within  the radius.

Multiple podcasts, interviews, articles and advertising in numerous veterinary publications have also been conducted, while exec chairman Dr Roger Aston attended the Animal Health, Nutrition and Technology Innovation Europe held in March in London.

Opportunity in canine cancer

B-cell Lymphoma in dogs has a poor prognosis and without treatment, many types of lymphoma are fatal within a few weeks.

PharmAust’s strategy is to take the middle ground in the treatment of B-Cell Lymphoma which is achieved by inducing stable disease for 4-6 months with minimal side effects, so that the family and the dog can enjoy the limited time together.

MPL is already approved for veterinary use for a different indication in food-chain animals, and the plan is to repurpose the drug as a safe and effective cancer treatment without the associated side effects of chemotherapy.

As for the addressable market, the canine cancer market is expected to be worth US$170m in 2030.

In Australia, pet ownership has dramatically increased with 62% of all Australians now owning at least one pet. Pet humanisation and premiumisation is also driving an increase in spend on pet services and pet needs.

PharmAust believes the MPL drug fills the major gap between untreated animals and chemotherapy. The company believes the market for MPL in canine cancer could be in the region of US$50m+pa.

 

 

 

This article was developed in collaboration with PharmAust, a Stockhead advertiser at the time of publishing.

 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.