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Spinogenix's Groundbreaking SPG302 Trial Results: Hope for Alzheimer's Treatment

On August 7, 2025, Spinogenix, Inc., a pioneering biopharmaceutical company in clinical stages, announced positive findings from the first cohort of their Phase 2a trial regarding SPG302, a potential first-in-class therapy targeting Alzheimer’s disease (AD). This innovative treatment aims to repair synaptic connections in the brain, potentially reversing cognitive declines associated with mild to moderate AD.

About the Phase 2a Trial

The Phase 2a study, identified by the clinical trial number NCT06427668, was a randomized, double-blind, placebo-controlled trial conducted in Australia. The trial set out to evaluate the safety and effectiveness of SPG302, which is administered as a once-daily pill. Participants included adults with a diagnosis of mild-to-moderate Alzheimer’s, regardless of their amyloid status, which traditionally complicates eligibility in similar studies. The trial consisted of two dosing cohorts that underwent a 24-week treatment period, including a 4-week double-blind phase followed by an open-label extension period.

Key Findings from the First Cohort

At the recent Alzheimer's Association International Conference (AAIC), the trial results from the initial cohort were showcased. Noteworthy findings included:

• - Safety Profile: SPG302 was safe and demonstrated good tolerability, with no serious or treatment-related adverse events recorded.
• - Cognitive Improvement: Participants observed a nearly 3-point increase in their Mini-Mental State Examination (MMSE) scores within four weeks, indicating rapid cognitive benefits.
• - Durability of Benefits: Improvements in cognitive function were sustained over the six-month duration of the open-label treatment, with notable enhancements in the Clinical Dementia Rating Sum of Boxes (CDR-SB) scores.
• - Compatible Therapies: The treatment was well tolerated when administered either as a monotherapy or alongside existing standard-care therapeutics.

Words from the Leadership

Dr. Stella Sarraf, CEO and Founder of Spinogenix, expressed optimism over these initial results. She stated, “The encouraging initial results from our Phase 2a trial reinforce SPG302’s potential to improve care and bring new hope for patients and their loved ones suffering from Alzheimer’s disease.” The forthcoming data set from this study is expected to be presented at the upcoming CTAD conference in December.

The Broader Implication for Alzheimer’s Research

Alzheimer’s disease, being the leading cause of dementia, accounts for 60 to 70 percent of dementia cases globally. Early loss of synapses marks the progression of the disease and significantly contributes to cognitive decline and memory loss. SPG302 provides an innovative approach to treating AD through its synaptic regenerative mechanism, aiming to improve cognitive function and enhance the quality of life for patients.

Neuroscientist Dr. Bruce Brew, a principal investigator in the trial based in Sydney, emphasized, “There is a clear link between synapse loss and cognitive decline in Alzheimer’s disease, yet an effective treatment has long eluded us. The results from this first cohort Phase 2 study demonstrate the considerable potential of SPG302, with early efficacy results showing competitive improvements in both MMSE and CDR-SB.

Future Directions

Looking ahead, Spinogenix plans to advance the development of SPG302, with hopes of bringing this transformative treatment to millions of patients in the U.S. The results from this trial represent a promising step forward, with subsequent Phase 3 studies on the horizon.

Conclusion

Spinogenix’s SPG302 could revolutionize the way Alzheimer’s disease is treated, offering a new ray of hope for countless individuals affected by this debilitating condition. With its leading approach in synaptic regeneration, the journey to final approval for SPG302 could pave the way for innovation within the realm of neurodegenerative diseases.

For further information on Spinogenix and its innovative treatments, visit www.spinogenix.com or connect via LinkedIn.