PharmAust is passing all the tests and is on schedule to start its crucial Phase I/II trial of monepantel in patients with Motor Neurone Disease, offering hope to suffers.
In an update on manufacture of tablets for its human trials, clinical stage biotech PharmAust (ASX:PAA) has announced its on target to meet clinical trial deadlines for its lead drug monepantel (MPL) in the treatment of motor neurone disease (MND) and COVID-19 following feedback from manufacturing partners.
The first patient is due to be recruited for the Phase I/II human trial in (MND) by the end of May 2022 while MPL manufacturing is scheduled for completion in mid-February 2022.
The Active Pharmaceutical Ingredient (API) will then be shipped to the US for formulation and tableting, which is scheduled for completion in mid-March 2022.
The company announced implementation of a successful accelerated stability program in mid-April should enable the release of the finished product in May 2022.
Furthermore, the company is planning to undertake trials of MPL in patients in people infected with SARS-CoV-2, the virus causing COVID-19, following a successful preclinical program.
“Late May 2022 remains the scheduled timing for recruitment of the first person into the MND trial,” Mollard said.
“We will then follow up this with recruiting for a COVID-19 antiviral clinical trial and are looking forward to a year of working through many milestones.”
High purity specification
Throughout the manufacturing and development process of MPL, PharmAust has focused on developing a high purity specification for the product, which is suitable for both human and veterinary purposes.
Year of milestones
PharmAust’s Chief Scientific Officer Dr Richard Molloy said 2022 is shaping up to be a significant year for the company, “we are looking forward to a year of working through many milestones.”
Apart from the MND and COVID trials, PharmAust has another two clinical trials in cancer planned to commence.
PharmAust is moving towards a Phase III clinical trial for canines with lymphoma, having expanded its studies into New Zealand.
Data from Phase II showed that combining MPL with prednisolone more than doubles the life expectancy of pet dogs with lymphoma, compared with standard-of-care (prednisolone alone).
Trials of MPL in human cancer are also expected to start later this year. Preparations for a Phase II human trial focusing on glioblastoma, esophageal, gastrointestinal and pancreatic cancers is also underway.
PharmAust has identified Principal Investigators in Italy and the UK to evaluate the new MPL tablet for the Phase 2 trials, as a follow-on from the Phase I clinical trial conducted at the Royal Adelaide Hospital in 2015.
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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