PharmAust and U-Vet gear up for Phase 2 clinical trial of leading drug candidate monepantel

PharmAust ASX PAA University of Melbourne U-Vet Werribee Animal Hospital Phase 2 clinical trial monepantel cancer
Recruitment of canine patients will commence at U-Vet to formally test monepantel in the new palatable and high dose tablet form in pet owners’ dogs with treatment-naïve B cell lymphoma.

Oncology company PharmAust (ASX: PAA) is on the home straight to commencing a milestone drug trial following the finalisation of contractual arrangements for its Phase 2 canine cancer trial, to be completed at the University of Melbourne’s U-Vet Werribee Animal Hospital.

PharmAust is currently developing a range of cancer therapeutics for both humans and animals and hopes that clinical trials will enable it to commercialise a drug that treats various cancers.

Canine success would open the door to human use – a much larger market, the company said.

The clinical-stage company said that recruitment of canine patients will now commence at U-Vet to formally test its repurposed registered drug monepantel (MPL). The drug will be tested (and eventually commercialised if trials are successful) in a “new palatable and high-dose tablet form” in order to treat treatment-naïve B cell lymphoma in dogs.

As it stands, monepantel serves as PharmAust’s lead drug candidate, which the company said is a novel, potent and safe inhibitor of the mTOR pathway – a key driver of cancer.

To date, monepantel has been evaluated in Phase 1 clinical trials in humans and dogs, showingthat it was “well-tolerated and produced a significant reduction in key prognostic biomarkers”.

Furthermore, PharmAust said side effects associated with existing products such as “Sirolimus” and “Afinitor” are limiting market growth while monepantel has comparatively “little or no side effects.”

Conducting a Phase 2 trial uniquely positions PharmAust to commercialise monepantel, which could eventually mean that dog owners across Australia and the US will obtain another weapon in the fight against cancer.

With over 180 million cats and dogs in the US alone, pet owners are spending around US$70 billion per year on their pets with a further US$17 billion (A$24 billion) for veterinary care.

According to market statistics, the pet drug market totalled more than US$10 billion (A$14 billion) in 2018.

In parallel, around 6 million dogs are diagnosed with cancer every year in the US. According to PharmAust, this represents a “significant unmet need for new oncology drugs” that could help penetrate a target market valued at anywhere between US$500 million and US$1 billion annually.

Monepantel has already been approved for veterinary use by US pharma company Elanco US, although PharmAust has decided to patent it as an anti-cancer drug that could also mean human applications.

From a veterinary standpoint, PharmAust already has an option agreement with Elanco for veterinary applications.

Trial at U-Vet

PharmAust’s Phase 2 trial will be conducted at U-Vet, one of Australia’s leading veterinary hospitals and overseen by Dr Claire Cannon, U-Vet’s Head of Small Animal Medicine and Oncology and a specialist veterinary oncologist.

Furthermore, Dr Cannon has been tasked with overseeing recruitment at other nominated sites within Australia, facilitating accelerated accrual rates and enabling faster trial endpoint determination.

PharmAust said multi-site involvement represents a “step-by-step process” and that it is looking forward to adding more sites in order to obtain more data and complete the trial with more veracity.

Just yesterday, PharmAust confirmed the safe arrival of its GMP-grade monepantel tablets with veterinarians who will conduct the trial.

The Phase 2 trial will formally determine activity in pet owners’ dogs with treatment naïve B cell lymphoma employing the new palatable and high-dose tablet form of MPL.

This newly developed tablet was optimised earlier this year to enable the dosing of pet dogs by their owners and to produce a formulation that could be commercialised.

The new palatable tablet will enable these studies to be of longer duration and will permit the determination of efficacy over prolonged periods of time.

If successful at this first stage, PharmAust then plans to broaden the trial base to test for low dose maintenance of progression-free survival and efficacy in other cancers.

“PharmAust is very pleased to be working with Dr Cannon and her team at U-Vet and the University of Melbourne and we look forward to sharing the data generated from the trial at U-Vet and other sites when they become available,” PharmAust chief scientific officer Dr Richard Mollard said.