Spinogenix Announces Full Enrollment in its Phase 2 Trial Evaluating SPG302 as a First-in-Class Synaptic Regenerative Therapy for Alzheimer's Disease

First Cohort Results to be Presented at AAIC in Toronto, July 2025 

FDA Clears IND in Alzheimer's Disease, Enabling Future Expansion to U.S.

LOS ANGELES, June 24, 2025 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced full enrollment of its Phase 2 clinical trial in Australia evaluating SPG302 for the treatment of people with Alzheimer's disease (AD). SPG302 is a once-daily pill with the potential to regenerate synapses and reverse cognitive decline in people with mild to moderate AD.

Spinogenix is completing a randomized, double-blind, placebo-controlled Phase 2 study of SPG302 (NCT06427668) to assess the safety, tolerability, and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. Two dose cohorts are being evaluated in a total of 24 participants. The first cohort has completed 24 weeks of treatment (inclusive of a double-blind phase and an open label extension period). Results from this cohort will be presented at the Alzheimer's Association International Conference (AAIC) in Toronto on July 27-31, 2025.

In parallel, the U.S. Food and Drug Administration (FDA) cleared Spinogenix's Investigational New Drug (IND) application for SPG302 for the treatment of people with AD.

"Full enrollment in our first AD clinical trial marks a significant step in our mission to bring SPG302 to patients and their loved ones suffering from this debilitating condition, and we are eager to share the encouraging results from our first patient cohort at AAIC," said Dr. Stella Sarraf, Spinogenix CEO and Founder. "The FDA's vote of confidence in SPG302 as a candidate treatment for AD – and the opportunity to evaluate this innovative therapy in the U.S. – represents the next step forward for Spinogenix, as we work to provide hope to the more than 55 million people worldwide battling AD, and pursue our mission in leaving no patients behind on the journey to find new treatment options."

AD is the most common cause of dementia, accounting for 60-70% of cases worldwide. Loss of synapses occurs very early in AD and is a major driver of cognitive and memory decline.

SPG302 offers the first synaptic regenerative approach to treating AD with the potential to improve cognition and quality of life. As such, SPG302 represents a potential new class of regenerative medicine therapeutics that can be used in combination with standard of care cholinesterase inhibitors, as well as recently approved antibody therapies targeting amyloid beta.

"We have long understood that synapse regeneration could be the key to improving cognition and quality of life in people with Alzheimer's," said Dr. Bruce Brew, MD, DSc, FRACP, FAAN, neurologist and Principal Investigator at St. Vincent's Hospital in Sydney, Australia. "Current therapies may slow disease progression, but they come with significant side effects and offer little improvement in cognitive function. SPG302 is the first therapy that may soon realize the promise of synapse regeneration, opening an entirely new avenue for treatment. The early trial results are promising, and FDA clearance of this IND opens the door for expansion of trials in the U.S., marking an important step forward in the journey to transform how we manage AD."

"I am thrilled by the latest milestone achieved by the Spinogenix team in advancing SPG302 in Alzheimer's disease, and look forward to U.S. patients having the opportunity to participate in important and groundbreaking clinical trials," added Jerre Stead, Chairman of Banner Alzheimer's Institute, Chairman of Stead Impact Ventures, and member of the Spinogenix Board of Directors.

About SPG302
SPG302 is a once-a-day pill being developed as a regenerative treatment for neurodegenerative and neuropsychiatric diseases with the unique ability to restore synapses, the key connections between neurons that allow people to think, plan, remember, and control movement. 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 is being evaluated as an investigational therapeutic in three disease indications: Alzheimer's disease (NCT06427668), ALS (NCT05882695) and Schizophrenia (NCT06442462). 

About Spinogenix
Current treatments for neurodegenerative, neuropsychiatric and neurodevelopmental conditions primarily focus on slowing disease progression or minimizing symptoms, leaving many without hope for improvement. Spinogenix is aiming to transform the treatment of these conditions through its pioneering first-in-class and paradigm-shifting synaptic regenerative and synaptic corrective therapeutics designed to restore depleted synapses and reverse synaptic degeneration and dysfunction – offering patients and their families a new reality of hope.

Spinogenix is developing two novel therapeutics: SPG302, which triggers neurons to produce new glutamatergic synapses and restore cognitive, motor, and other functions in ALS, Alzheimer's disease, schizophrenia and other diseases; and SPG601, which works at the synaptic level to correct specific dysfunctions in Fragile X Syndrome (FXS) that underlie many core symptoms. The company has received FDA and EMA Orphan Drug designations for ALS as well as FDA Orphan Drug and Fast Track designations for FXS. More information on Spinogenix can be found at www.spinogenix.com or follow us on LinkedIn.

Media Contact
Arielle Bernstein Pinsof
FINN Partners
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Investor Relations
Dan Albosta
Spinogenix, Inc.
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SOURCE Spinogenix