SPG302 is a once-a-day pill with the potential to regenerate synapses to reverse declines in cognitive function in people with Alzheimer’s disease

LOS ANGELES, Calif., August 1, 2024 — Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced that enrollment is now open in Australia for their Phase 2 clinical trial evaluating SPG302 for the treatment of people with Alzheimer’s disease (AD), the most prevalent form of dementia worldwide.

“The SPG302 trials are a completely different approach to tackling Alzheimer’s Disease,” stated Bruce Brew, MD, DSc, FRACP, FAAN, neurologist and trial Principal Investigator at St. Vincent’s Hospital in Sydney, Australia. “Unlike other approaches, SPG302 has the prospect for some degree of regeneration and consequent improvement in memory, instead of just slowing the disease. This is a refreshing, long-awaited and cutting-edge approach to the disease, if it’s successful, it could be the dawn of a new era in treating Alzheimer’s disease.”

“There are currently no approved drugs for Alzheimer’s disease that focus on restoring function to reverse the course of disease by targeting the synapses. At Spinogenix, our mission is to offer new hope to people battling AD, not just by slowing the disease but by potentially reversing it, offering a significant departure from conventional approaches” said Stella Sarraf, Ph.D., Spinogenix Chief Executive Officer and Founder.

The Phase 2 trial will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of a once-a day pill of SPG302 in adult participants with mild-to-moderate Alzheimer’s disease. Enrollment is currently open at St. Vincents Hospital, Sydney, NSW, Australia with plans for a second site opening soon at Flinders Medical Center, Adelaide, SA, Australia. Additional information is available on ClinicalTrials.gov (NCT06427668).

SPG302 is also being evaluated in Amyotrophic lateral sclerosis (ALS) patients in Australia, with plans to enroll ALS patients in the U.S. following recent FDA IND clearance. Additional information on the ALS trial may be found on ClinicalTrials.gov (NCT05882695).

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 motor functions. 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 U.S. FDA Orphan Drug Designation for the treatment of ALS. Additional information on the clinical trials evaluating SPG302 can be found on ClinicalTrials.gov (NCT05882695 and NCT06427668). SPG302 has received preclinical support from the U.S. National Institutes of Health and the Department of Defense.

About Alzheimer’s Disease
Alzheimer’s Disease is the most common cause of dementia, accounting for ~60-70% of dementia cases worldwide. Loss of synapses occurs very early in Alzheimer’s and is a major driver of progressive impairments in cognition and memory. Currently, there is no cure for AD and medications that are approved for use in AD have only modest and temporary impact on symptoms.

About Spinogenix 
Spinogenix is dedicated to developing transformative therapeutics for conditions involving the loss or dysfunction of synapses. Our lead clinical-stage synaptic regenerative drug, SPG302, is a first-in-class therapeutic designed to reverse synapse loss and improve cognitive and motor functions in neurodegenerative and neuropsychiatric diseases such as ALS, Alzheimer’s disease, and schizophrenia. In addition, we are developing a synaptic function therapeutic, SPG601, designed to improve cognitive and other symptoms in Fragile X Syndrome by correcting specific abnormalities in synaptic communication. More information on Spinogenix can be found at www.spinogenix.com or follow us on LinkedIn. 

Spinogenix Contact
info@spinogenix.com

Media Contact
Kristin Politi, Ph.D.
LifeSci Communications
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