Perth-based biotech PharmAust (ASX: PAA) has reported a June quarter heavily focused on the effects of its primary drug candidate monepantel on patients with motor neurone disease.
For the three months ending June, the company reported completion of tablet manufacturing and an acceleration of tablet stability data, as well as the receipt of regulatory and ethics approvals for the start of a human clinical trial.
In April, Alithia Life Sciences was appointed to manage the trial, which will test the safety and tolerability of monepantel in patients living with MND and aim to identify signs that the drug can slow progression of the disease.
The data, in conjunction with concurrent animal studies, will determine whether monepantel should proceed to larger Phase 2 studies.
Alithia’s appointment will be fully-funded through an $881,000 drug development grant awarded by FightMND, which is the largest independent funding body for MND research in Australia.
During the quarter, PharmAust received the first and second instalments of the grant, totalling $300,845.
The first instalment was dependent on PharmAust commencing manufacture of cGMP-grade (current Good Manufacturing Practice) monepantel tablets while the second was paid after the completion of the one-month GMP accelerated stability of the newly-prepared tablets.
The third instalment will be payable upon recruitment of the first patient to the clinical trial and further payments will be made on the completion of additional milestones.
PharmAust expects that monepantel will eventually receive orphan drug designation by the US Food and Drug Administration for the indication of motor neurone disease.
During the June quarter, PharmAust also made significant progress in canine trials of monepantel with the aim of developing a product which supersedes the use of prednisolone alone and can reduce or replace the use of chemotherapy in dogs.
Earlier trials have determined the drug to have effective anti-cancer activity with minimal side effects, and the company will now embark on phase 3 registration trials.
In comparison, the most common side effects of a dog being treated with chemotherapy include gastrointestinal issues (such as vomiting and loss of appetite) and a decrease in blood cell counts.
Canines treated with MPL during the trial were reported to have experienced a higher quality of life with minimal adverse events.
PharmAust is in discussions with a leading global pharmaceutical company as well as other potential partners to co-develop and commercialise MPL for the treatment of veterinary cancers.
Further to the responses and outcomes in canines, the company continues to take key steps towards the evaluation of MPL in human trials, with clinical interest focused on leukaemia, glioblastoma, oesophageal, gastrointestinal, ovarian and pancreatic cancers.
PharmAust has been identifying clinical centres worldwide which may be capable of sourcing unvaccinated patients with COVID-19 for a phase 1 trial.
The company has focused its search in smaller eastern European nations and some non-European Union states which have large populations of unvaccinated patients.
Three clinical centres in Romania and Bosnia have expressed interest in participating and recruiting sufficient numbers of suitable patients for the study.
PharmAust said the “critical step” of site selection in terms of clinical suitability and patient recruitment numbers has resulted in delays to the start of the in the commencement of the COVID-19 trial.
PharmAust wholly-owned subsidiary Epichem spent the quarter advancing its novel and disruptive waste conversion and re-purposing technology known as oxidative hydrothermal dissolution (OHD).
A benchtop flow reactor was built and commissioned for operation, while proof-of-concept work was completed on coal and ligno-cellulosic biomass.
Epichem has partnered with the WA School of Mines (Curtin University) to research and develop OHD for use in hydrometallurgy and mineral processing applications.
Earlier this month, Epichem was awarded a $45,200 grant from National Energy Resources Australia which will be used to fund an OHD pilot program to assist a multinational oil and gas company in providing a carbon neutral solution for plastics recycling across its Australian operations.
In June, PharmAust appointed pharmaceutical executive Fiona Milner to the role of general manager of Epichem.
It also announced the resignation of chief scientific officer Dr Richard Mollard, and said it would leverage the expertise of Epichem to cover the responsibilities of that role to reduce duplication of jobs and costs.
PharmAust’s cash position at the end of the quarter was $2.43 million, keeping it well funded to continue its current work program.