PharmAust says it’s Phase-2 trial for the treatment of canine B-cell Lymphoma with Monepantel (MPL) is expected to be completed by mid-2023.
So far, the company has had some solid results demonstrating anti-cancer activity, with one patient surpassing 240 days with stable disease and an excellent Quality of Life (QoL).
The MPL drug has extended the survival rate three-fold, to a median of 150 days – with an attractive side-effect profile and minimal adverse events.
Since the last trial update in Feb, three new dogs have been recruited, and one dog (Bella) has completed the 28-day trial.
Extension of survival time and Quality of Life is key
B-cell Lymphoma in dogs has a poor prognosis and without treatment, many types of lymphoma are fatal within a few weeks.
PharmAust’s (ASX:PAA) commercial 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.
In the Phase-2 study, a 12-year-old Beagle ‘Louie’, has surpassed 240 days (8 months) as a result of being treated solely with MPL, and showing no side effects while his QoL of remains excellent.
“Thus, it appears that dogs given MPL + prednisolone (or, in Louie’s case, MPL on its own) after the 28-day trial period are living three times longer than expected with good quality of life and no chemotherapy-related side effects,” the company says.
“The combination of MPL with prednisolone has extended median survival to these pet dogs of 150 days.
“More importantly, owner surveys from dogs in the trial indicate an excellent Quality of Life (QoL) score feedback.”
Phase-2 will wrap up mid-year
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.
Thirty-six dogs have been treated using MPL monotherapy so far and the company is now preparing for a successful Phase-2 completion by mid-2023 – and the commencement of a subsequent Phase-3 registration trial.
PharmAust requires greater than or equal to 18 dogs with an overall clinical benefit out of 46 dogs to meet its statistical endpoint.
To complete this Phase-of the trial, the company requires 8 of a further 20 dogs with Stable Disease at Day 28 to meet Bayesian outcomes for a successful Phase-2 trial.
Potential Corporate Outcome on MPL Vet anti-cancer application
Pet ownership has dramatically increased with 62% of all Australians now owning at least one pet. Pet humanization and premiumisation is driving an increase in spend on pet services and pet needs.
The canine cancer market is expected to be US$170m in 2030.
The highly marketable condition of progression-free-survival in canines as an outcome from trials as well as recurring revenues from commercialisation of MPL for canines is an attractive partnership for big pharma.
PharmAust believes this product concept fills the major gap between untreated animals and chemotherapy. The market for MPL in canine cancer could be in the region of US$50m+pa.
Phase 2 results in B-Cell Lymphoma have shown MPL to be a very safe drug that promotes a high quality of life during treatment, as well as being able to offer progression free survival as a registration end-point. The fact that MPL can act as a cancer suppressor with the potential to be taken for long periods of time at high doses, presents a previously unmatched recurring revenue outcome for a licensing partner that should command a higher premium.
A licensing deal would enable PharmAust to facilitate MPL’s veterinary cancer application while helping fund future human cancer and COVID-19 trials. There would be potentially a handsome future royalty income to PharmAust from MPL sales in canines.
Typically a licensing deal involves an upfront cash payment in recognition of investment, which would currently be ~$20m-$25m, as well as a 8-12% royalty on all sales of the drug and additional milestone payments. Such a deal would mark a significant commercial outcome for PharmAust and bolster funding for all foreseeable future clinical trials.
This article was developed in collaboration with PharmAust Limited (ASX:PAA), 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.