Clinical-stage biopharmaceutical company PharmAust (ASX:PAA) reports the first patient as part of its second cohort has been dosed in its phase one/two trial testing the effects of monepantel (MPL) in individuals living with motor neurone disease (MND).
The company says the patient will receive twice the corresponding dosage received by patients in Cohort 1, and that the outcome of this rising dose study will be a key determinant in proceeding to a phase two trial in MND.
Adding on, PharmAust notes the first patient to be dosed has now surpassed 140 days of MPL treatment with no material safety issues or Serious Adverse Events (SAEs).
MPL is reported to have been well tolerated by all MND patients at the first dosing level and pharmacokinetics (PK) confirmed drug absorption, and that it will continue to supply MPL tablets to all 6 patients in Cohort 1 that elected to remain on treatment.
It is reported patients from Cohort 1 will continue to be monitored for cognitive function with ALSFRS-R being collected monthly, and that at the end of each dosing visit, all 3 scales will be collected.
The company also notes progression of the trial with concomitant escalation of MPL dosing is consistent with the good safety profile during the Cohort 1 stage of the study. Furthermore, the Safety Monitoring Committee has reviewed the safety data and pharmacokinetics from the first dosage level and authorised progression of the trial to the Cohort 2 stage.
In addition, continued safety and efficacy data from the trial will also be used to facilitate a phase two study in COVID-19 patients.
With the first patient of the second cohort now dosed, PharmAust announces it will now focus on enrolling a further 5 patients in order to complete the Cohort 2 group of 6 patients.
PharmAust is an ASX-listed clinical-stage company developing therapeutics for both humans and animals that specialises in repurposing marketed drugs lowering the risks and costs of development. The company’s current MND phase one/two trial is overseen by Dr Susan Mathers of Calvary Health Care, Bethlehem, Statewide Progressive Neurological Disease Service, Melbourne, and will include a second trial site headed by Professor Dominic Rowe of the Centre for Motor Neurone Disease Research Faculty of Medicine and Health Research at Macquarie University, Sydney.
This clinical study is being undertaken to determine the tolerability, safety, pharmacokinetics, and preliminary efficacy of oral MPL in MND sufferers. The trial also comprises a 4 week escalating dose of MPL.