- PharmAust (PAA) and research and development company, Syngene International, have teamed up to produce monepantel for human trials
- The pair will make 10 kilograms of monepantel that abides by the good manufacturing practice (GMP) standard
- Once produced, monepantel will be administered to people with motor neurone disease (MND) in a human clinical trial in October next year
- This trial will be co-funded by leading MND foundation, FightMND
- Following this, a trial will begin to examine monepantel’s effect on cancer patients
- Company shares are trading 4.76 per cent higher at 11 cents
PharmAust (PAA) has begun producing 10 kilograms of good manufacturing practice (GMP)-grade monepantel (MPL) to be used in human clinical trials.
One of the trials will examine the effects of MPL-tablets in people with motor neurone disease (MND) and the other will assess its effects on cancer patients.
GMP is a globally-recognised standard that requires rigorous and continually monitored processes to make sure the drugs are safe and effective when administered to patients. This level of manufacture meets standards required for clinical trials in Australia, the U.S. and Europe.
PharmAust will manufacture MPL with Syngene International, an India-based research, development and manufacturing services company.
Syngene will conduct feasibility studies before synthesising the full 10 kilogram product amount and synthesis is expected by June 2021.
“The commencement of this GMP synthesis program for clinical R&D purposes is a significant next step for PharmAust,” PharmAust Chief Scientific Officer Dr Richard Mollard said.
“We are delighted to collaborate with PharmAust to manufacture and supply clinical trial batches of monepantel to support phase one and two clinical trials in humans,” Syngene International CEO and Managing Director Jonathan Hunt said.
The MND trial will be co-funded by Australia-leading MND foundation, FightMND, and is expected to begin in October next year.
Once data is collected from this trial, PharmAust will commence a trial with cancer patients towards the end of 2021.
Company shares are trading 4.76 per cent higher at 11 cents at 12:33 pm AEDT.