The biotech’s therapy monepantel gets another 12 months to gather data.
Perth-based biotech PharmAust has been given the green light to start an open-label extension trial of its product monepantel for patients with motor neurone disease/amyotrophic lateral sclerosis.
Monepantel has been through the Phase I MEND study and the 12 patients who participated in that will now continue to receive treatment through the OLE for a further 12 months.
The Monash Health Human Research Ethics Committee approved the OLE which will start next month at Calvary Health Care Bethlehem, led by Associate Professor Susan Mathers, with patients at Macquarie University, under the care of Professor Dominic Rowe, to follow soon after.
The OLE study will further test the hypotheses that monepantel administration to individuals living with MND/ALS will safely reduce disease-associated protein accumulation in motor neurons and provide therapeutic benefits.
“We are delighted to receive ethics approval for this OLE study,” said PharmAust CEO Dr Michael Thurn.
“It is very positive that all 12 patients who completed the Phase 1 MEND study are pleased and available to continue treatment with monepantel for a further 12 months.
“This study allows us to capture safety and efficacy data within a quality framework suitable for regulatory submission.
“We hope our efforts bring about a much-needed new therapy for MND/ALS.”
The OLE study is registered on the ClinicalTrials.gov registry here.
The study’s primary objective is to assess the long-term safety and tolerability of monepantel. The secondary objective is to assess the biomarkers and efficacy endpoints.
