PharmAust completes first patient cohort enrolment and initial dosing for MPL trial in MND patients
PharmAust reported MPL was “well tolerated” in the first cohort of MND patients in its phase 1/2 clinical trial.
PharmAust (ASX: PAA) has enrolled the first patient cohort for its phase 1/2 clinical trial testing its lead drug candidate monepantel (MPL) in sufferers of motor neurone disease/amyotrophic lateral sclerosis (MND/ALS).
The first cohort comprises six MND patients, who have all had their initial treatment level of MPL, which was “well tolerated”.
Patients were recruited at two sites: Calvary Health Care Bethlehem in Victoria, and Macquarie University’s Centre for Motor Neurone Disease Research in New South Wales.
The phase 1/2 study is designed to determine the tolerability, safety, pharmacokinetics and preliminary efficacy of oral MPL in MND patients.
This study is open label and includes a four-week escalating dose of MPL.
‘Well tolerated’ dosage
With the first dosage level “well tolerated”, patient recruitment for the next dose escalation will begin in the new year.
All dosage levels will be assessed for serious adverse events, adverse events, safety blood results, ECG, vital signs, and pharmacokinetics.
The review will be completed after the last participant in the cohort completes day 29.
“The progressive elevation of MPL levels, as we progress the pharmacokinetic evaluation in MND will facilitate the determination of safe dosing levels for our COVID trial to be undertaken next year.
FightMND is assisting with financing the trial after committing a total of $881,085, which is payable in instalments after certain milestones are achieved.
About MPL
MPL is a novel, potent and safe inhibitor of the mTOR pathway, which has “key influences” in cancer growth and neurogenerative diseases.
As well as evaluating MPL in MND/ALS, PharmAust is undertaking research into the drug’s anti-cancer effect in humans and canines.
Latest study results in canines, shows MPL can more than double the life expectancy in dogs with cancer.
During phase 2a and 2b trials of canines with a recent Naïve B-cell lymphoma diagnosis and no prior treatment, MPL has demonstrated effective anti-cancer activity.