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Spinogenix Receives Approval from the Australia Human Research Ethics Committee for Phase 1 Clinical Trial of SPG302

Monday, July 10, 2023

Spinogenix, a clinical-stage biopharmaceutical company focused on developing small molecule drugs for neurological conditions, has announced that it has received approval from Australia's Human Research Ethics Committee (HREC) to initiate human clinical trials for their novel drug, SPG302, in the treatment of Amyotrophic Lateral Sclerosis (ALS).

SPG302 is a synthetic small molecule with the ability to penetrate the blood-brain barrier and is orally bioavailable. It works by increasing synapses, which are the connections between neurons responsible for cognitive functions and motor control. Animal studies have shown promising results, demonstrating improved cognition and motor behaviors in neurodegenerative disease models.

Dr. Stella Sarraf, the Founder and CEO of Spinogenix, expressed satisfaction with the HREC approval and highlighted the significant need for innovative therapeutics for ALS. Current treatments for ALS provide only limited extensions of life and are not universally well-tolerated. The human clinical trials will assess the safety, tolerability, and potential efficacy of SPG302 in both healthy volunteers and ALS patients.

The Phase 1 study will evaluate various aspects, including pharmacokinetics, pharmacodynamics, and electrophysiological, respiratory, and behavioral assessments. The trial will follow a randomized, double-blind, placebo-controlled design and include both single and multiple ascending dose cohorts. It will also feature an expansion cohort for ALS patients. The primary focus will be on assessing the drug's ability to regenerate synapses, making it a unique approach in ALS treatment.

Dr. Merit Cudkowicz, Director of the Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital, expressed support for Spinogenix's progress and highlighted the potential of synapse regeneration as a complementary treatment alongside existing and emerging ALS therapies.

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