Spinogenix Receives Approval to Start Phase 2 Trial of SPG302 for Alzheimer's

Spinogenix, Inc., a clinical-stage biopharmaceutical company focused on creating innovative therapies to restore synapses and enhance patients' lives, has announced the commencement of a Phase 2 trial for SPG302 aimed at treating mild-to-moderate Alzheimer's disease (AD) in adults. This trial has received approval in Australia.

The Phase 2 study will be conducted at multiple centers and will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical efficacy of SPG302 in adult AD participants. The clinical trial will be divided into two segments: Part A will be a pilot, placebo-controlled, randomized safety and preliminary efficacy cohort, followed by an expansion cohort in Part B. More information about this trial can be found on ClinicalTrials.gov under the identifier NCT06427668.

Stella Sarraf, Ph.D., Chief Executive Officer and Founder of Spinogenix, expressed her enthusiasm, stating, “Gaining approval from Australia’s HREC for this trial in Alzheimer’s Disease makes this the third Phase 2 study we have initiated this year. This milestone reflects our swift progress in bringing groundbreaking therapeutic solutions to those suffering from neurodegenerative and neurodevelopmental diseases. The significant unmet need for novel therapies addressing synaptic pathology in AD underscores the potential of our first-in-class, synaptogenic small molecule to deliver meaningful clinical impact. We are developing SPG302 as a once-a-day pill to simplify administration and increase accessibility, enabling patients worldwide to benefit.”

SPG302 has already completed a Phase 1 safety study in healthy subjects in Australia. It is also being evaluated in ALS patients, with plans to include patients in the U.S. following recent FDA IND clearance. Further details about the ALS trial are available on ClinicalTrials.gov (NCT05882695).

SPG302 is a once-a-day pill designed as a regenerative treatment for neurodegenerative and neuropsychiatric diseases. It uniquely restores synapses, the essential connections between neurons that facilitate thinking, planning, memory, and motor functions. As a first-in-class approach to treatment, SPG302 has the potential to reverse declines in cognitive, respiratory, and motor functions. The U.S. FDA has granted SPG302 Orphan Drug Designation for treating ALS. Additional information on the clinical trials for SPG302 can be found on ClinicalTrials.gov (NCT05882695 and NCT06427668). SPG302's development has received preclinical support from the U.S. National Institutes of Health and the Department of Defense.

Alzheimer’s Disease is the most prevalent cause of dementia, responsible for approximately 60-70% of dementia cases worldwide. Synapse loss occurs very early in Alzheimer's and is a significant factor in the progressive impairment of cognition and memory. Currently, no cure exists for AD, and the medications approved offer only modest and temporary relief from symptoms.

Spinogenix is committed to developing transformative therapeutics for conditions that involve synapse loss or dysfunction. Their lead clinical-stage candidate, SPG302, aims to reverse synapse loss and enhance cognitive and motor functions in neurodegenerative and neuropsychiatric diseases such as ALS, Alzheimer’s disease, and schizophrenia. Additionally, Spinogenix is developing a therapeutic to improve behavior in Fragile X Syndrome.