Pharmaust Shares Surge On Positive Survival Data For Monepantel

PharmAust Ltd (ASX: PAA) shares were trading ~17% higher intra-day after revealing impressive survival data for patients treated with monepantel (MPL).

The Open-Label Extension (OLE) study is investigating the long-term safety, tolerability, and efficacy of MPL in patients with Motor Neurone Disease (MND)/Amyotrophic Lateral Sclerosis (ALS).

Data shows a statistically significant survival benefit for MPL compared to untreated matched-controls from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.

Importantly, the treatment with MPL significantly reduced the risk of death by 91% when compared to PRO-ACT matched controls.

Moving to Phase 2/3 study

PharmAust Managing Director Dr Michael Thurn commented: “I’m very pleased that we have completed enrolment in the OLE study as this is a significant milestone for PharmAust.

 “The updated survival analysis conducted by Berry Consultants is extremely encouraging, as is the updated efficacy analysis that indicates MPL continued to slow the rate of disease progression in patients with MND/ALS.

 “These results provide an exciting backdrop ahead of the anticipated commencement of the pivotal adaptive Phase 2/3 STRIKE study in H2 2024.”

Orphan Drug Designation

Last month, PharmAust secured Orphan Drug Designation (ODD) from the US FDA for MPL and its treatment of MND/ALS.

Read: Pharmaust Granted Orphan Drug Designation For Monepantel In USA

The FDA grants ODD status to assist and encourage companies to develop safe and effective treatments for rare diseases and disorders.

Critically, the ODD status provides incentives, including tax credits, grants and seven years of market exclusivity following drug approval.

PharmAust’s application was based on data that demonstrates MPL can induce autophagy in diseased cells, and consideration of the pathology of the disease.

 

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