Synapse-regenerating drug could reverse decline in Alzheimer’s


Spinogenix has initiated a Phase II trial to evaluate SPG302 for the treatment of adult participants with mild-to-moderate Alzheimer’s disease (AD), following approval for the trail in Australia.

The study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult AD participants.

The clinical trial will consist of two parts: a pilot, placebo-controlled, randomised safety and preliminary efficacy cohort (Part A) and an expansion cohort (Part B).

“Having gained approval from Australia’s HREC, this trial in AD will be the third Phase II study initiated by Spinogenix across our pipeline this year,” said Stella Sarraf, Spinogenix Chief Executive Officer and Founder.

“There remains a significant unmet need for novel therapies that address the underlying synaptic pathology central to AD and our first-in-class, synaptogenic small molecule has the potential to provide a meaningful clinical impact. We are developing SPG302 as a once-a-day pill to further remove barriers to administration and enable easier access so that patients around the world can benefit.”

SPG302 has completed the Phase I safety study in healthy subjects in Australia and is currently being evaluated in ALS patients in Australia, with plans to enrol patients in the US following recent Food and Drug Administration (FDA) IND clearance.

SPG302 is a once-a-day pill being developed as a regenerative treatment for neurodegenerative and neuropsychiatric diseases.

The synaptic regenerative activity of SPG302 represents a first-in-class approach to treating these diseases and has the potential to reverse declines in cognitive, respiratory, and motor function.

SPG302 has been granted FDA Orphan Drug Designation for the treatment of ALS.

Diana Spencer, Senior Digital Content Editor, DDW

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