Biotech company PharmAust (ASX: PAA) has been invited by not-for-profit organisation FightMND to submit a comprehensive grant application which could grant up to $1.8 million to fund Phase 2 and 3 clinical trials in an effort to find a treatment for Motor Neurone Disease (MND)

Earlier this month, PharmAust submitted a Letter of Intent to FightMND in response to the call for clinical study proposals. This initiative is part of FightMND’s Phase 2 clinical trial and expanded access program for innovative treatments in Motor Neurone Disease/Amyotrophic Lateral Sclerosis (MND/ALS) within the Australian Clinical Trials Consortium of hospitals. The principal investigator for the study is Associate Professor Susan Mathers.

The call for clinical study proposals encompasses academic-industry collaborations, including pharmaceutical and biotechnology companies, academic institutions, universities, hospitals, and MND researchers globally. FightMND has earmarked substantial financial support, with grants of up to AUD $1,800,000 available for successful applicants.

PharmAust received confirmation from FightMND that its Letter of Intent was successful, paving the way for the company to progress to the next stage by submitting a full grant application by March 24, 2024. The final recipients will be announced in July 2024.

The proposed Phase 2 and 3 studies are designed as a multicenter, randomised, placebo-controlled, adaptive clinical trial over a 48-week period. The primary objectives include assessing the efficacy of monepantel compared to a placebo in slowing down the progression of MND/ALS, measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score and survival. 

The study incorporates an adaptive design, with an interim analysis planned at Week 24 by unblinded statisticians, allowing for potential early termination based on success or futility.

PharmAust’s CEO, Dr Michael Thurn, expressed enthusiasm about the prospect of securing funding from FightMND, stating, “Gaining access to undiluted funds to help offset the costs of drug development is a goal of every biotechnology company.” 

Dr Thurn acknowledged FightMND’s pivotal role in the development of monepantel, as the foundation fully funded the initial Phase 1 study. With promising results to date, PharmAust is optimistic about the potential benefits of monepantel for patients with MND/ALS.

The broader biotech industry commonly faces substantial costs in funding clinical trials. Developing a new drug from discovery to market approval is a lengthy and resource-intensive process, often involving extensive research, preclinical testing, and multiple phases of clinical trials. 

Securing grants from organisations like FightMND is crucial for biotech companies, providing financial support that accelerates the development of potential treatments for devastating diseases like MND/ALS.