PharmAust encouraged by positive monepantel survival rate assessment

Clinical-stage biotechnology company PharmAust (ASX: PAA) has received positive survival benefit assessments for its monepantel (MPL) neurodegenerative disease treatment.

A new study undertaken by specialists Berry Consultants indicates that MPL provides a statistically significant survival benefit for patients with motor neurone disease (MND) / amyotrophic lateral sclerosis (ALS) compared to untreated matched controls from the pooled resource open-access ALS clinical trials (PRO-ACT) database.

The study also confirmed that treatment with MPL reduces the risk of death by 91% when compared to PRO-ACT matched controls.

Improved survival

The study quantified the effect of MPL on the survival of patients up to 24 May 2024 compared to historical control data from the PRO-ACT database, treating them with MPL for varying durations with a median of 16.4 months.

Berry Consultants a variety of standardised metrics to match PRO-ACT controls to each MPL treatment patient.

They then constructed two possible comparison datasets from the PRO-ACT database to increase the robustness of the analysis.

The study concluded that the survival patterns between MPL treatment and PRO-ACT control groups differ significantly for each dataset tested, even using the most conservative analysis.

New study scheduled

In revealing the study results, PharmAust also announced that enrolments have been completed for an open-label extension (OLE) study.

Ten of the 12 patients who completed the Phase 1 MEND study have been successfully enrolled for the next phase.

PharmAust plans to dose eligible patients with 10 milligrams of MPL per kilogram of body weight daily for an additional 12 months.

The OLE study involves two sites in Australia, Calvary Health Care Bethlehem – led by Associate Professor Susan Mathers – and Macquarie University, led by Professor Dominic Rowe.