Pharma Focus America

Spinogenix Receives Approval to Begin Phase 2 Clinical Trial of SPG302 for Alzheimer’s Disease Treatment

Friday, June 21, 2024

Spinogenix, Inc. has received approval to begin Phase 2 trials of SPG302 in Australia for treating adults with mild-to-moderate Alzheimer’s disease (AD). This clinical study aims to evaluate SPG302's safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy. It consists of two parts: a pilot placebo-controlled randomized cohort to assess safety and preliminary efficacy (Part A) and an expansion cohort (Part B). Additional details about the Phase 2 trial are available on (NCT06427668).

Spinogenix, commented on this milestone, emphasizing the company's commitment to developing innovative therapies for neurodegenerative and neurodevelopmental diseases. SPG302, a first-in-class synaptogenic small molecule, addresses the synaptic pathology central to AD and is designed as a once-daily pill for improved patient access.

SPG302 has successfully completed Phase 1 safety trials in healthy subjects in Australia and is currently being evaluated in ALS patients in the same region, with plans for enrollment in the U.S. following recent FDA IND clearance. More information on the ALS trial can be found on (NCT05882695).

SPG302 is a once-daily pill aimed at regenerating synapses, crucial connections between neurons essential for cognitive, respiratory, and motor functions. Its synaptic regenerative properties represent an innovative approach in treating neurodegenerative and neuropsychiatric diseases, potentially reversing cognitive decline. SPG302 has received Orphan Drug Designation by the U.S. FDA for ALS treatment and has received preclinical support from the U.S. National Institutes of Health and the Department of Defense. For more details on SPG302 clinical trials, visit (NCT05882695 and NCT06427668).

Alzheimer’s Disease is the leading cause of dementia globally, affecting 60-70% of dementia cases. Early synaptic loss significantly contributes to cognitive and memory decline in AD patients. Current treatments provide limited and temporary symptomatic relief, with no cure currently available.



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