US biotech company Spinogenix is conducting a world-first clinical trial in Australia. The company is investigating a therapy that could slow the progression of motor neurone disease.
Spinogenix is recruiting 112 participants for the trial, set to begin in 2024. It is seeking healthy volunteers and patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease.
Nucleus Network will conduct the trials at its facilities in Melbourne, Victoria. The company is one of Australia’s largest Phase 1 clinical trials organisations. It has conducted over 1,000 trials for global biotechnology and pharmaceutical companies.
‘We are extremely pleased to receive approval from [Australia’s] Human Research Ethics Committee to proceed with human clinical trials,’ says Spinogenix Founder and CEO Dr. Stella Sarraf. ‘These human clinical trials will help us determine safety and tolerability in healthy volunteers. They will also provide early signals of efficacy of our novel, first-in-class drug to help improve the lives of people with ALS.
A new therapy to treat ALS
Founded in 2016, Spinogenix develops transformative therapeutics for diseases involving synaptic loss and dysfunction.
Spinogenix’s SPG302 treatment candidate is designed to increase the number of synapses in nerve cells. Synapses are the key connections between neurons that allow people to think, plan, remember and control motor functions. These faculties are diminished in neurodegenerative diseases like ALS.
In tests on mice, SPG302 was found to slow the progression of symptoms. It was also found to prolong life span by restoring broken neuron connections in the brain.
The current therapies for ALS provide only a modest extension of life and are not well tolerated by all patients. ALS is almost invariably fatal within 3 to 5 years of diagnosis.
A top destination for clinical trials
Australia has more than 50 clinical trial networks offering Phase I – IV clinical trials. Many clinical trial sites are in biomedical precincts close to universities, research institutions and private industry. Australia offers clinical trials for several biologics sub-sectors, including gene therapies, cell therapies, antibody-based therapies, CAR-T therapies and RNA therapies.
Data from clinical trials conducted in Australia is accepted by the US Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA). Australia’s streamlined regulatory approval system reduces the time it takes start clinical trials.
Australia also offers grants and incentives that can help reduce clinical trial costs.
Find out more about Australia’s clinical trials capabilities.
How Austrade helped
Austrade provided Spinogenix with information about Australia’s clinical trials ecosystem and facilitated introductions to local partners. Additionally, Spinogenix participated in Austrade’s Clinical Trials Roadshow in October 2022, which was delivered in partnership with IQVIA, 360 Biolabs, Bentleys and Nucleus Network.
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Published: 15 September 2023