PharmAust says it will expedite the Covid-19 trial of lead monepantel into Phase 2, which could facilitate faster recruitment.

Clinical stage biotech PharmAust (ASX:PAA) has provided an update of its human clinical trials currently in progress.

The company is undergoing two human clinical trials of its lead asset, monepantel (MPL) – a Phase 1 trial in Motor Neurone Disease (MND), and a Phase 2 trial in COVID-19. As part of these trials, PharmAust has manufacturing its own MPL tablets.

The manufacturing program included the production of API (Active Pharmaceutical Ingredient) at Syngene International Limited (NYSE: SYNGENE) in India, tabletting at Catalent Pharma Solutions (NYSE: CTLT) in the US, as well as stability and purity analysis – all of which have now been completed.

These tablets were specifically designed for the MND trial, and have now passed all required stability, purity analysis and formulation testing.

The human trials can now proceed after the tablets were shipped to the clinical sites in Sydney and Melbourne.

Update on Phase 1 trial in Motor Neurone Disease

The much anticipated Phase 1 clinical trial on patients with Motor Neurone Disease (MND) is now on track to complete formalities in May. PharmAust has appointed a Safety Monitor, has commenced screening patients and will  commence recruitment and treatment of patients in June.

The trial is funded by the Australian charity, FightMND.

In September last year, FightMND pledged $881,085 in funding for PharmAust to examine the effects of its lead drug MPL on MND.

MND or ALS (Amyotrophic Lateral Sclerosis) is the name given to a group of diseases that affect nerve cells controlling our everyday movements, including breathing. It became widely known following the affliction of the late renowned physicist, Stephen Hawking.

Trial preparations were commenced following the first instalment of $200k made by FightMND in April. The second instalment of approx. $100k is now payable to PharmAust after the completion of the one-month accelerated stability testing of the newly prepared MPL tablets, while the third instalment of the grant ($173k) will be payable upon commencement of the trial. Further instalments for a total commitment of $881,085 will be paid by FightMND to PharmAust as additional milestones relating to the clinical trial are met.

PharmAust says it will report on the recruitment and treatment of the first patient that fulfills the inclusion criteria, and will provide updates thereafter.

Update on Phase 2 trial in COVID-19

PharmAust says it has been identifying clinical centres capable of sourcing patients with the required COVID- 19 progression and vaccination status.

Current research has focussed on the Eastern Block European states, where there remain a significant number of unvaccinated patients.

PharmAust requires unvaccinated patients with progressive infection in order to satisfy the inclusion criteria for determining anti-viral activity.  Ukraine was one of the countries initially proposed, however, this is of course no longer tenable, and the Company re-focused the search in other smaller Eastern EU states that have large populations of unvaccinated patients.

Three clinical centres in Romania and Bosnia have now expressed their interest in participating in the study, and in recruiting sufficient numbers of qualified patients.

The next steps would be to provide protocols for the study for the identified clinical centres in those two countries.

PharmAust says it’s still continuing to search for contingency sites, including those in Poland.

The search for the right clinical site(s) is an extremely important and critical step of the process, both in terms of clinical suitability and patient recruitment numbers, and it’s one of the reasons why there’s been a delay in the commencement of the trial.

 

Expedited study into Phase 2

However, given the earlier commencement of the MND trial, the PharmAust Board has decided to rely on the MND trial to provide the important Phase 1 pharmacokinetic (PK) data for both the MND and COVID-19 trials.

This will allow PharmAust to undertake a Phase 2 trial in COVID-19, rather than a Phase 1 study, which will facilitate faster recruitment as the company has been advised by the CRO that COVID-19 infected patients generally prefer participating in a Phase 2 study.

PharmAust has engaged Ergomed Clinical Research, a subsidiary of the London Stock Exchange listed Ergomed plc (LON: ERGO) to be the contract research organisation (CRO) for the COVID-19 clinical trials.

Ergomed has previously advised that COVID-19 infected patients generally prefer participating in a Phase 2 study (instead of Phase 1) – so conducting a Phase 2 study will facilitate faster recruitment

From a financial viewpoint, an expedited study into Phase 2 will also benefit PharmAust, saving it of around $1.5 million.

As a precursor to the human trial, PharmAust has signed an agreement to evaluate MPL in transgenic “humanised” mice, which will express the receptors that the COVID-19 virus binds to in humans.

Efficacy in this anti-viral model is expected to provide further evidence of the ant-viral effects of MPL.

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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