The deal is aimed at driving access to the experimental drug which is currently being studied for its potential to slow the progression of ALS. Credit: Shutterstock / David Herraez Calzada

California-based trial access company, WideTrial, will participate in a National Institutes of Health-funded initiative to provide pre-approval access to the investigational Amyotrophic lateral sclerosis (ALS) drug, ibudilast, backed by $22m in funding.

The deal is aimed at driving access to the experimental drug which is currently being studied for its potential to slow the progression of ALS, with a focus on targeting those presently ineligible for ongoing trials with funding supplied by a grant from the National Institute of Neurological Disorders and Stroke (NINDS).

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The initiative will aim to enrol 200 ALS patients across all three Florida-based Mayo Clinics and aims to measure ibudilast’s effect on ALS progression using a blood test that shows whether neurofilament protein levels have changed in patients with ALS.

Jess Rabourn, CEO of WideTrial, said: “We are pleased to support this important initiative to expand access to investigational ALS treatments.

“We believe every patient deserves a chance to explore potential therapies, regardless of their eligibility for traditional research trials. The collaboration is part of our commitment to empowering patients and providers with solutions that democratize access to research-stage medicines.”

The Expanded Access Pathway is intended for patients living with a life-threatening condition who are currently unable to access other clinical trials. Previously ibudilast has seen some success in trials testing it against conditions such as autism spectrum disorder (ASD) and long-covid but is yet to be fully demonstrated for its use in ALS.

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Research conducted by the US advocacy group, ALS Association, found that the condition is far more likely to affect those between the ages of 40 and 70, with an average age of 55 at the time of diagnosis, it also found that about 90% of ALS cases occur without any known family history or genetic cause.

Elsewhere in the field of ALS treatments, South Korean biotechnology firm DR.NOAH BIOTECH has received approval from the US Food and Drug Administration (FDA) for a Phase I clinical trial of NDC-011. Meanwhile, The University of Birmingham has entered into a collaboration with Swedish pharmaceutical company TikoMed for its Phase II trial of the drug, ILB.