PharmAust bolsters leadership as CEO attends global ALS/MND Symposium
Health & Biotech
Health & Biotech
Special Report: PharmAust is beefing up its management team with two key appointments in preparation for upcoming regulatory and clinical milestones for its development programs.
Clinical-stage biotechnology company PharmAust (PAA) has announced it has strengthened its management team with the appointment of Dr Carol Worth as CMC (Chemistry, Manufacturing & Controls) operations manager and John Clark as clinical operations manager.
PAA says Worth has more than three decades of industry expertise and a commitment to quality control and quality assurance.
Her most recent role was as the quality manager at Epichem Pty Ltd, and she previously served as the chief technical officer at both Suda Pharmaceuticals (ASX:SUD) and Solbec Pharmaceuticals.
Additionally, Worth has overseen product development initiatives at Thermalife International Pty Ltd/ Pharmasolv Laboratories Pty Ltd.
PAA says Clark brings more than two decades of pharmaceutical industry experience in overseeing phase I – IV clinical trials across diverse therapeutic areas and multiple global regions.
In his recent position, he was the senior project manager at a global CRO, where he led the clinical operations team and provided comprehensive oversight for a national CNS trial.
He has also held various leadership positions in clinical operations, driving the implementation of clinical programs.
Clark has a documented track record in project management and stakeholder engagement, coupled with extensive knowledge of ICH-GCP and regulatory prerequisites.
He obtained his B.Sc. in Biomedical Sciences from the University of the West of England.
PAA last week announced it had completed its Phase 1 MEND investigation on the drug monepantel (MPL), targeting patients with motor neurone disease (MND/ALS).
The company is currently on schedule to unveil the primary outcomes of this study in Q1 2024. Additionally, they have applied for Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA).
An ODD aim to encourage the development of medications or biological products for rare diseases with several incentives including market exclusivity and tax credits for several years.
The Phase 1 MEND study encompassed 12 patients with MND/ALS—a condition affecting the nervous system, leading to muscle weakness and impaired physical abilities.
This disease affects more than 350,000 individuals globally and is uniformly fatal, with an average life expectancy of around 27 months post-diagnosis.
The study design involved two cohorts of six patients, each progressively receiving higher dose levels of MPL — which could reduce the rate of degeneration and loss of motor neurons in the brainstem’s anterior horns and motor nuclei — in a staggered design approach over time.
CEO Dr Michael Thurn is attending the 34th International Symposium on ALS/MND in Switzerland, from December 6 to 8, which is the largest annual conference dedicated to research in the field.
Thurn says more than 1,000 delegates from global pharmaceutical companies, Government Institutions and University research institutes, and not-for profit ALS/MND Associations worldwide are attending the symposium.
He says in a milestone year PAA has significantly strengthened its management team with the appointment of Worth and Clark in preparation for upcoming regulatory and clinical milestones for its development programs.
“With the recent announcement that all patients had completed the Phase 1 MEND Study of monepantel for motor neurone disease, it was important for PharmAust to carry momentum into the new year to launch a Phase 2 study,” he says.
“Worth will oversee the GMP manufacture of monepantel and the provision of clinical supplies for our upcoming clinical studies. John Clark will lead global clinical operations as the Company positions itself as a leading developer of neurodegenerative medicines.”
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.