PharmAust’s deep pipeline of clinical trials on lead drug Monepantel means that a new CEO with strong knowledge of FDA certifications is needed.

Following rapid progress in its clinical trials pipeline, PharmAust (ASX:PAA) announced that it was looking for a new Australian-based CEO.

The Board of Directors is seeking a CEO with strong knowledge in US FDA certification and global licensing agreements, as the company moves to more advanced trial milestones.

PharmAust says the chosen individual should also display proven abilities in regular contact and communication with the investment community.

Dr Roger Aston, who has 40 years’ experience in the pharmaceutical and healthcare industry, will remain as Chairman of the Board, but will transition into a non-executive role.

The Board says it will continue to ensure that PharmAust has the necessary expertise, industry experience and diversity to expedite drug development and commercialisation for treatments of cancers and viral and neurological diseases.

PharmaAust’s deep clinical trials pipeline

PharmAust has a deep pipeline of clinical trials in various stages of progress focusing on its lead asset, Monepantel (MPL).

MPL is a novel, potent and safe inhibitor of the mTOR pathway – a pathway having key influences in cancer growth and neurodegenerative diseases.

One of monepantel’s key clinical attributes is its low toxicity as evidenced by its approved use in food chain animals.

PharmAust’s current pipeline include:

Phase 3 trial for Canine B-Cell Lymphoma

The company is currently undergoing a Phase-2 trial on MPL for the treatment of canine B-cell Lymphoma, which is expected to be completed by mid-2023.

So far, results have demonstrated anti-cancer activity, with survival rate increasing three-fold to a median of 150 days. One dog – Louie the beagle – has today surpassed 287 days with stable disease and an excellent Quality of Life (QoL).

PharmAust is now preparing for a successful Phase-2 completion by mid-2023, and the commencement of a subsequent Phase-3 registration trial.

The market for MPL in canine cancer could be in the region of US$50m+pa.

A licensing deal would enable PharmAust to facilitate MPL’s veterinary cancer application while helping fund future human clinical trials.

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.

Preparation for Motor Neuron Disease (MND) Phase 2 trial

PharmAust has completed enrolment of all 12 patients in Cohorts 1 and 2 in its clinical trial of MPL in Motor Neurone Disease/Amyotrophic Lateral Sclerosis (MND/ALS).

Once the last patient of Cohort 2 has been dosed, PharmAust will commence an interim analysis to evaluate potential indicatory changes in biomarkers and pharmacodynamics – which is the biochemical and physiological effect of a drug.

Results from the interim analysis are expected in May 2023.

The company is now  looking to expedite the start of Phase-2 of this trial, and expects to proceed upon receiving favourable efficacy biomarker results under the interim analysis.

According to the International Alliance of ALS/MND Associations, MND affects over 350,000 people globally and kills more than 100,000 people every year with no cure.

The average life expectancy of someone who has MND is around 27 months, and the disease is progressive – meaning symptoms get worse over time.

It’s also worth noting the total MND/ALS addressable market is US$3.6 billion per annum with current ALS drug on the market Riluzole already reaching ~US$1 billion in annual sales.

Phase 2 human cancer trial

Not only does PharmAust have clinical trials underway in MND in humans and cancer in canines, the company is set for further trials in human cancer to commence this calendar year.

This could provide PharmAust with multiple ‘shots on goal’ at a +$1Bn drug success.

Recent data from PharmAust’s B-Cell Lymphoma cancer trial in canines suggests positive correlation, and possible translation, for targeting multiple different cancers in humans.

If MPL human trials return similar efficacy as in canines, this would be an absolute game changer and major entry into the billion dollar human cancer industry.




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.