PharmAust puts experienced hands back on its rudder

PharmAust reappoints Dr Michael Thurn as managing director and CEO to lead its push in human neurodegenerative diseases
Company has also appointed neuroscientist Dr Nicky Wallis as its chief scientific officer
Phase 2/3 clinical trial of MPL in MND/ALS expected to start in H2 2024.

Special Report: PharmAust has reappointed Dr Michael Thurn as its managing director and chief executive officer to lead it through a major reset to become a global leader in neurodegenerative diseases.

Dr Thurn, who has previously served as the company’s CEO, oversaw the successful completion of the Phase 1 MEND Study of monepantel being developed for the treatment of motor neurone disease/ amyotrophic lateral sclerosis (MND/ALS).

He also engaged with the US Food and Drug Administration, resulting in PharmAust (ASX:PAA) being granted a pre-investigational new drug meeting and orphan drug designation for MPL for the treatment of ALS.

In an effort to position the company for the next phase of clinical development and commercialisation, Dr Thurn also established a world-class scientific advisory board, made several key management hires and formed a partnership with clinical study design and statistical analysis specialists Berry Consultants.

His ability to create and maintain strong shareholder relations also led to a successful $3.5m capital raising at a 4.8% premium to the 15-day volume weighted average price late last year.

“We are delighted to welcome Michael back to PharmAust as managing director and CEO,” non-executive chairman Sergio Duchini, who took up the role earlier this month, said.

“His deep understanding of our lead MPL program and proven track record of successful leadership, shareholder engagement and building company value will be crucial as we continue to advance our clinical and commercial objectives.”

Stronger scientific management

As part of the company’s efforts to become a forerunner in neurodegenerative disease treatment, PAA has also appointed Dr Nicky Wallis as its chief scientific officer.

Dr Wallis is a neuroscientist with over 12 years’ global expertise in clinical development from the pre-clinical through to Phase 3 drug and device development.

She has a proven track record in managing multi-site, international clinical studies across the US, Europe, Australia, and New Zealand, with a strong focus on regulatory submissions and compliance, cross-functional collaboration, and vendor management.

Prior to joining PharmAust, Dr Wallis provided clinical development consulting services to both private and public biotechnology companies in Australia, with a focus on central nervous system diseases.

Duchini said Dr Wallis’ deep understanding of MND/ALS at the molecular level coupled with her comprehensive experience in preclinical and clinical development of neurodegenerative diseases would be instrumental in exposing the potential utility of MPL for other application.

These include its potential use to treat Alzheimer’s disease, Parkinson disease and multiple sclerosis.

Focus on human neurodegenerative diseases

PAA’s decision to focus on human neurodegenerative diseases follows the recently completed Phase 1 MEND study of MPL in the treatment of MND/ALS demonstrating that the drug crosses the blood-brain barrier and is safe to use at therapeutically meaningful doses.

Preliminary efficacy data also showed that the administration of MPL at a dose of 10mg/kg may slow the progression of MND/ALS by up to 58% and increase life expectancy by as much as 56.5 months, depending on the severity of the disease at baseline.

These outcomes are especially notable compared to currently approved treatments, which only extend life expectancy by 2 to 6 months.

The company is progressing the design and implementation of a pivotal adaptive Phase 2/3 clinical trial, which is expected to begin in H2 2024 subject to receiving the necessary approvals.

It will also start pre-clinical work to explore the utility of MPL as a treatment in other human neurodegenerative diseases, such as Alzheimer’s and Parkinson’s.

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.