Spinogenix Begins Open Enrollment for Phase 2 Study of SPG302 for Alzheimer’s Treatment

Spinogenix, Inc., a pioneering clinical-stage biopharmaceutical company, has announced the commencement of enrollment for their Phase 2 clinical trial in Australia, investigating the efficacy of SPG302 for treating Alzheimer's disease (AD). SPG302 is a once-daily oral medication with the potential to regenerate synapses, crucial for cognitive functions, and aims to reverse cognitive decline in AD patients.

Bruce Brew, MD, DSc, FRACP, FAAN, a neurologist and the Principal Investigator for the trial at St. Vincent’s Hospital in Sydney, emphasized the innovative nature of SPG302. He noted that unlike existing treatments which primarily aim to slow the progression of the disease, SPG302 offers the possibility of actual regeneration and improvement in memory. This novel approach could herald a new era in Alzheimer’s disease treatment.

Stella Sarraf, Ph.D., the Chief Executive Officer and Founder of Spinogenix, highlighted that current Alzheimer's medications do not focus on restoring synaptic function to reverse the disease. Spinogenix's mission is to potentially reverse the course of AD and offer new hope to patients, marking a significant shift from traditional treatment methodologies.

The Phase 2 trial will assess the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adults with mild-to-moderate Alzheimer’s disease. Currently, enrollment is open at St. Vincent's Hospital in Sydney, with plans to extend to Flinders Medical Center in Adelaide. Further details about the study are available on ClinicalTrials.gov (NCT06427668).

In addition to Alzheimer’s, SPG302 is also being tested for its effectiveness in patients with Amyotrophic Lateral Sclerosis (ALS) in Australia. Following the recent FDA IND clearance, ALS patient enrollment is planned to expand to the U.S. Information regarding the ALS trial can be accessed on ClinicalTrials.gov (NCT05882695).

SPG302 is designed as a regenerative treatment for various neurodegenerative and neuropsychiatric diseases. Its unique ability to restore synaptic connections, which are essential for cognitive and motor functions, represents a pioneering approach in medical treatments. By potentially reversing declines in these functions, SPG302 stands out as a first-in-class therapeutic. The drug has already received U.S. FDA Orphan Drug Designation for ALS treatment. Preclinical support for SPG302 has been provided by the U.S. National Institutes of Health and the Department of Defense.

Alzheimer’s Disease is the leading cause of dementia, contributing to approximately 60-70% of cases globally. Early loss of synapses is a significant factor behind the progressive cognitive and memory impairments seen in AD. Currently, no cure exists for Alzheimer’s, and the available medications only offer modest and temporary symptom relief.

Spinogenix is committed to creating transformative treatments for diseases characterized by the loss or dysfunction of synapses. Their leading drug, SPG302, is intended to reverse synapse loss and enhance cognitive and motor functions in conditions like ALS, Alzheimer's disease, and schizophrenia. Additionally, Spinogenix is developing SPG601, a therapeutic aimed at improving cognitive and other symptoms in Fragile X Syndrome by addressing specific synaptic communication abnormalities.

The company's innovative work in synaptic regenerative treatments aims to significantly improve the lives of patients suffering from these debilitating conditions.