PharmAust solidifies leadership team ahead of key Stage 2/3 MPL study

Clinical-stage biotechnology company PharmAust (ASX: PAA) has strengthened its leadership team as it progresses a number of key treatments for neurodegenerative diseases.

In addition to reappointing Dr Michael Thurn as chief executive officer, PharmAust has also awarded him the additional title of managing director.

The company has named the highly regarded Dr Nicky Wallis as chief scientific officer (CSO).

Strong leadership

Dr Thurn has driven PharmAust’s clinical and commercial strategies since joining the company in September 2023.

During this time, he oversaw the successful completion of the Phase 1 MEND study of monepantel (MPL) being developed for the treatment of motor neurone disease/amyotrophic lateral sclerosis (MND/ALS).

He has also been responsible for establishing a scientific advisory board, making several key management hires and forming a partnership with clinical study design and statistical analysis specialists Berry Consultants.

He also oversaw a successful capital raise at a premium late last year.

Current managing director John Clark will return to his previous role of chief operating officer and step down from the board of directors.

Experienced clinician

A neuroscientist, Dr Wallis brings to her new PharmAust role more than 12 years of global expertise in clinical development, spanning pre-clinical through to Phase 3 drug and device development.

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

Her vast experience includes roles such as clinical trials program specialist at the Australian Clinical Trials Alliance, vice president of clinical operations at Lateral Pharma Biotech and clinical project manager at Orygen Youth Mental Health Research.

Non-executive chair Sergio Duchini said Dr Wallis’s previous research at the University of Melbourne and The Florey, which focused on understanding the pathogenesis of MND/ALS and Alzheimer’s disease, will be highly valuable to PharmAust’s work in those areas.

“Her deep understanding of MND/ALS at the molecular level, coupled with her comprehensive experience in preclinical and clinical development of neurodegenerative diseases, will be instrumental in exposing the potential utility of MPL for other applications such as Alzheimer’s disease, Parkinson’s disease and multiple sclerosis,” he said.

ODD breakthrough

Dr Thurn’s engagement with the US Food and Drug Administration (FDA) resulted in the company being granted a pre-investigational new drug meeting and the subsequent orphan drug designation (ODD) MPL received in mid-May.

The ODD status assists companies in their development of safe and effective treatments for rare diseases and disorders.

It also provides incentives, including tax credits, grants, a waiver of some administrative fees for clinical trials and seven years of market exclusivity following drug approval.

The important designation came as PharmAust continues to progress to its pivotal registration adaptive Phase 2/3 study, which will commence in H2 CY2024.

There are approximately 140,000 new cases of ALS/MND diagnosed worldwide each year.