PharmAust has set up veterinary trial centres in Australia, New Zealand and the United States to evaluate the anti-cancer benefit of Monepantel (MPL) tablets in dogs diagnosed with untreated B-cell lymphoma.

Thirty-five dogs have so far been treated using MPL monotherapy (excluding 5 dogs removed from the study) and the company has successfully demonstrated that when used on its own, MPL provides statistically significant effective anti-cancer activity.

Further recruitment of pet dogs with untreated B cell lymphoma will allow a successful Phase-2 evaluation to be completed and due to the successful outcomes of the Phase-2 study, PharmAust (ASX:PAA) is preparing for the commencement of a subsequent Phase-3 registration trial.

The company requires greater than or equal to 18 dogs with an overall clinical benefit out of 46 dogs to meet its statistical endpoint.

Minimal side effects compared to chemo

Side effects were minimal or not detected. For comparison, the most common side effects for a dog being treated with chemotherapy include gastrointestinal effects (vomiting, diarrhea or loss of appetite) and decreases in blood cell counts.

Not to mention that during chemotherapy, owners need to take precautions when handling their pets and their waste – chemotherapy drugs may be excreted in the urine and faeces, leaving children and pregnant women at risk of exposure when cleaning up urine and faeces for the duration of their pet’s therapy.

Two dogs in the trial have had a partial response as assessed by the administering veterinarians which is defined as a decrease in tumour size (sum of longest diameter as defined by RECIST criteria) of >30%, and no new lesions, and eight others have enjoyed a stable disease response.

Louie surpasses 220 days on MPL only

Unfortunately, no matter the treatment protocol, most dogs with lymphoma will die from the disease, which is why stabilisation (as opposed to regression) of the disease with good Quality of Life (QoL) is regarded as an excellent outcome.

A fantastic example is 12-year-old Beagle “Louie” who has surpassed 220 days being treated solely with MPL, showing no side effects while his quality of life remains excellent.

The company says Louie’s lymphoma has stabilised, after blood tests did not indicate any progression from the previous examination and his peripheral nodes have increased by only 2% since October 2022.

Interestingly, Louie was diagnosed with Progressive Disease (PD) at the end of his 28 day trial. This is further support that that REGARDLESS of whether a dog has achieved Stable Disease (SD) by day 28, dogsgiven MPL + prednisolone (or in Louie’s case, MPL on its own) after the 28 day trial period are all living 3 times longer than expected with good quality of life and no nasty side effects.

The life expectancy using standard of care (palliative steroid therapy) typically provides for 42-56 days survival in association with a range of adverse events. The combination of MPL with prednisolone has provided average extension of survival to these pet dogs of 153 days. More importantly, owner surveys from dogs in the trial indicate an excellent Quality of Life (QoL) score feedback.

Phase-2 trial enrolment continues

Going forward, PharmAust plans to utilize in depth market and competitor research to build greater understanding of the potential new market segment that Monepantel use in B Cell lymphoma can deliver for pets/owners and veterinarians

The company will also continue with the enrolment of dogs into the current Phase-2b study, with the aim of allowing a more in-depth analysis of

  • Disease and Animal Factors potentially impacting Overall Survival Times (OST) outcomes;
  • QoL experienced by dogs during treatment; and
  • The impacts of differing dose regimens of MPL/Prednisolone on both OST and QoL outcomes.

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 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 USD500M+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, 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.

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