Press Release

Spinogenix Announces Approval from the Australia Human Research Ethics Committee to Initiate a Phase 2 Human Clinical Trial of SPG302 for the Treatment of Alzheimer’s Disease

Phase 2 study is designed to evaluate the safety, tolerability, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate Alzheimer’s disease.

SPG302 is also being evaluated in a Phase 1/2 study in ALS, which has completed dosing of healthy volunteer cohorts, showing dose proportionality, tolerability, and plasma levels aligned with efficacy in animal models.

LOS ANGELES, Calif., June 20, 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 the initiation of Spinogenix’s Phase 2 trial to evaluate SPG302 for the treatment of adult participants with mild-to-moderate Alzheimer’s disease (AD) was approved in Australia.

The Phase 2, multicenter 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, randomized safety and preliminary efficacy cohort (Part A) and an expansion cohort (Part B). Additional information on the Phase 2 trial is available on ClinicalTrials.gov (NCT06427668).

“Having gained approval from Australia’s HREC, this trial in Alzheimer’s Disease will be the third Phase 2 study initiated by Spinogenix across our pipeline this year,” said Stella Sarraf, Ph.D., Spinogenix Chief Executive Officer and Founder. “This marks a significant milestone in our rapid progress to bring truly innovative therapeutic solutions to those battling neurodegenerative and neurodevelopmental diseases. 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 1 safety study in healthy subjects in Australia and is currently being evaluated in ALS patients in Australia, with plans to enroll 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 candidate 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 parallel, we are also developing a synaptic function therapeutic designed to improve behavior in Fragile X Syndrome. 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
kpoliti@lifescicomms.com
(646) 876-4783

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