Spinogenix

Overview

Spinogenix, Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel therapeutics aimed at restoring synapses to treat neurodegenerative, neuropsychiatric, and neurodevelopmental conditions. Founded in 2016 and headquartered in San Diego, California, Spinogenix was established by Dr. Stella Sarraf. The company has gained recognition for its innovative approach in treating conditions like ALS, Alzheimer’s Disease, schizophrenia, and Fragile X syndrome. Spinogenix has secured significant funding and collaborative support, contributing to its progress in clinical trials and drug development.

Recent Developments

January 2025: Spinogenix announced that the U.S. FDA granted Fast Track designation to SPG601, aimed at treating Fragile X Syndrome, which is a common inherited form of autism. This designation is expected to expedite the clinical development and review timelines for SPG601.
October 2024: Spinogenix launched a glaucoma program and appointed Dr. Robert Weinreb, a world-renowned expert in ophthalmology, to its Science Advisory Board. The company is advancing SPG302 for potential therapeutic use in glaucoma, aiming to prevent synapse degeneration linked to this condition.
September 2024: Initiation of a Phase 2 clinical trial for SPG302 designed to evaluate its efficacy and safety in treating schizophrenia. The trial received approval from Australia’s Human Research Ethics Committee, which granted clearance to enroll participants.
July 2024: Spinogenix opened enrollment for its Phase 2 clinical trial evaluating SPG601 for the treatment of Fragile X Syndrome. This move aligns with its mission to advance research and provide new therapeutic options for this condition.
November 2024: Approval from the Australian Human Research Ethics Committees was secured to start a Phase 2 study evaluating SPG302 in Alzheimer’s patients. This marks a significant milestone as SPG302 is expected to offer both symptom alleviation and disease-modifying effects.

Attribute	Information
Founding Date	2016
Headquarters	San Diego, California
Founders	Dr. Stella Sarraf
Revenue	Not publicly disclosed
Profits	Not publicly disclosed
Key Investors	U.S. Department of Defense, National Institutes of Health
Industry	Biopharmaceutical
Number of Employees	Not publicly disclosed

Early History

Spinogenix was founded in 2016 by Dr. Stella Sarraf, leveraging her extensive experience in pharmaceuticals and venture capital. She established Spinogenix with the vision of developing innovative therapeutics to address unmet medical needs related to synaptic dysfunction and loss, which underpin many neurodegenerative and psychiatric disorders. Early on, Spinogenix identified small molecules that could facilitate synaptic regeneration, leading to the formulation of the SPG302 series. These efforts were partly funded by grants from the U.S. Department of Defense and the National Institutes of Health, which recognized the potential impact of synaptic restoration in treating conditions like ALS and schizophrenia.

Company Profile and Achievements

Spinogenix operates on a business model focused on the development and commercialization of first-in-class small molecule therapeutics that address synaptic loss. Its lead candidates include SPG302, targeting conditions like ALS, schizophrenia, and Alzheimer’s, and SPG601, which is being investigated for Fragile X syndrome. Significant milestones in Spinogenix's journey include:

FDA Designations: SPG601 received the FDA Fast Track and Orphan Drug designations, underscoring its potential as a novel treatment for Fragile X syndrome.
Clinical Progress: Successfully advancing Phase 2 trials for various drugs, with SPG302 showing promising results in regenerating synapses to reverse cognitive deficits.
Innovative Platform: Utilizing its "Transient Activators of Glutamatergic Synaptogenesis" (TAG) platform, Spinogenix pioneers drugs that encourage synaptic formation, distinguishing itself from other neurodegenerative therapeutics.
Strategic Collaborations: The company has established collaborations with key medical institutions to accelerate its research and development.

Current Operations and Market Position

Spinogenix is currently conducting multiple clinical trials across the globe. Its strategic focus on neurodegenerative diseases places it in a competitive position within the biopharmaceutical industry. The company’s approach of addressing root issues, such as synapse loss, sets it apart in a field dominated by therapeutics that merely slow disease progression. Spinogenix competes with larger pharmaceutical firms but leverages its niche expertise in synaptic regeneration as a competitive advantage.

Conclusion

Spinogenix is at the forefront of developing transformative therapies aimed at addressing synaptic loss, a critical factor in numerous neuropsychiatric and neurodegenerative diseases. With a firm commitment to innovation and patient care, Spinogenix is poised to make significant impacts in its field. As its drug candidates advance through clinical trials, the company holds the potential to profoundly change treatment landscapes for ALS, Alzheimer’s, schizophrenia, and other conditions. Going forward, Spinogenix's innovative therapeutic pipeline and strategic partnerships position it as a key player, potentially setting new standards in neurology and psychiatry treatments.