• New chief executive has experience executing clinical studies
  • Dr Thurn was formerly part of the TGA’s Drug Safety Evaluation Branch
  • Progress continues to be made on MND and canine cancer trials

 

PharmAust is strengthening its management team with the appointment of Dr Michael Thurn as chief executive officer from 1 September following an international recruitment search.

Thurn has broad experience in drug discovery, development, regulation and commercialisation, acquired through leadership roles in research organisations and industry, including early-stage, fast-growing, private and publicly listed biotechnology companies.

He has led a a variety of US Food and Drug Administration (FDA) Investigational New Drug (IND) applications across a range of therapeutic areas and the evaluation of drugs and vaccines for registration in Australia as part of the Therapeutics Goods Administration’s Drug Safety Evaluation Branch.

Importantly for PharmAust (ASX:PAA), which is in the midst of several clinical studies, Thurn has also been responsible for the execution of Phase 1 and 2 clinical trials and business development activities across animal and human health products. He has also submitted protocols for Phase 3 clinical trials.

Over his 25-year career in biotechnology, he has also co-founded companies such as Botanix Pharmaceuticals (ASX:BOT), Mimetica, Spinifex Pharmaceuticals, Cytopia, Xenome and Novogen. Dr Thurn led Spinifex to a USD$700 million acquisition by Novartis and played a significant role in securing Cytopia a licensing deal with Novartis for AUD$274 million.

During this time, he gained Australian and US capital markets exposure and has successfully accessed funding through private and public channels, partnerships and non-dilutive means.

“I am thrilled that this robust and competitive process has culminated in identifying a biotechnology leader of Michael’s calibre,” chairman Dr Roger Aston, who is transitioning to a non-executive role, said.

“As we look to the future the Board is very confident Michael will continue to build momentum on the positive interim results from the ongoing Phase 1 Motor Neurone Disease study to increase market awareness and create significant value for our shareholders.”

Dr Thurn said that joining PharmAust at this time was an incredible opportunity given the company’s “exciting and maturing animal health and human pipeline”, excellent board as well as world-class clinical advisors and collaborators.

 

Clinical studies

PharmAust is currently progressing the Phase 1 trial of its lead drug candidate monepantel (MPL) in people with Motor Neurone Disease/Amyotrophic Lateral Sclerosis (MND/ALS) as well as Phase 2 of MPL in dogs with B-cell lymphoma.

Already, results from the MND/ALS trial are offering hope that it can slow progress of the disease, which is invariably fatal.

The company recently reported that Neurofilament Light Chain (Nfl) protein concentrations – increases of which appear to correlate with MND progression – in the plasma of participants in its Phase 1 clinical trial do not increase following MPL treatment.

Only one of 12 patients in cohorts 1, 2 and 3 showed increased Nfl, while the other
11 showed no significant change in Nfl.

The drug also continues to be well tolerated by all patients in each of the three cohorts, which have progressively higher dosage levels, who have also elected to continue with MPL treatment.

This is backed by a interim pharmacokinetic analysis of plasma MPL and Monepantel Sulphone (MPLS) concentrations which found no serious adverse effects even in patients with higher concentrations of MPLS.

Meanwhile, the Phase 2 trial for MND in dogs with B-cell lymphoma already shows clear signs of meeting its objectives with two dogs experiencing a +30% reduction in cancer tumour while another 10 have enjoyed a stable disease response.

To date, the combination of MPL with Prednisone (a cortisone-like medicine used to relieve swelling, redness, itching, and allergic reactions) has extended survival three-fold to a median of 150 days whilst maintaining quality of life.

This appears to be a significant result given that B-cell lymphoma in dogs typically has a poor prognosis and without treatment, many types of lymphoma are fatal within a few weeks.

 

Upcoming milestones

Planning is already underway for Phase 2 of PharmAust’s MND/ALS trial whilst Cohort 4 – the final group – has commenced with an even higher dose of MPL.

The Phase 1/2 study is being funded by a commitment of $881,085 by FightMND, the largest independent funder of MND research in Australia.

PharmAust is also progressing confidential discussions with potential licensing partners for canine cancer, which could provide funding for future clinical trials.

The Phase 2 trial for MPL in dogs with B-cell lymphoma is expected to be completed in the current quarter.

 

 

 

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.

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