Press Release

Spinogenix Announces Second Grant Award from U.S. Department of Defense to Further Advance SPG302, the First Synaptic Regenerative Drug to Treat Amyotrophic Lateral Sclerosis (ALS)

SAN DIEGO, Calif., Sept. 26, 2023 — Spinogenix, Inc., a clinical-stage biopharmaceutical company developing novel small molecule drugs for neurodegenerative conditions, today announced that it has been awarded a new grant for nearly $1 million from the U.S. Department of Defense’s (DoD) Congressionally Directed Medical Research Programs (CDMRP). The support will allow Spinogenix to complete additional safety studies as required by the FDA to further advance development of the company’s lead clinical candidate SPG302 as a new potential regenerative treatment for Amyotrophic Lateral Sclerosis (ALS). In July, Spinogenix initiated its first phase 1 human clinical studies for SPG302 in Australia.

There remains an unmet need for new innovative therapeutics for ALS (Lou Gehrig’s disease), which is almost invariably fatal within 3-5 years of diagnosis. The therapies that are currently approved for ALS provide for only a modest slowing of disease progression. Ultimately, effective treatment of ALS may involve a combination of approaches to both slow disease progression and regenerate neural circuitry that are lost to the disease.

SPG302 is a once-a-day tablet being developed as a regenerative approach to treating ALS, one that is highly differentiated from currently approved and emerging therapies. SPG302 has a unique mechanism of action wherein it induces an increase in synapses, the key connections between neurons that allow people to think, plan, remember and control motor functions – faculties that are diminished in neurodegenerative diseases including ALS. A wealth of data indicates that a loss of dendritic spine synapses is an early and progressive feature of ALS pathogenesis that may contribute to both motor and cognitive symptoms.

“We are extremely pleased to receive this new grant from the DoD to help us advance the development of our potentially groundbreaking ALS treatment,” said Spinogenix Founder and Chief Executive Officer Stella Sarraf, PhD. “Spinogenix’s novel therapeutic, SPG302, regenerates dendritic spine synapses and thus has the potential to slow and reverse the fundamental process of synaptic degeneration at work in ALS and other neurodegenerative diseases like Alzheimer’s Disease.”

In January 2021, Spinogenix was awarded a previous DoD grant, in collaboration with Dr. Rita Sattler at the Barrow Neurological Institute and Dr. Justin Ichida at the USC Keck School of Medicine, to study the effects of SPG302 in ALS animal models and human iPSCs (induced pluripotent stem cells) from patients with ALS and from healthy volunteers. This new grant will build upon the progress made in the past 2 years and accelerate the impact this therapeutic can have on people.

For more information contact: info@spinogenix.com

About Spinogenix 
Spinogenix was founded with the mission to develop transformative therapeutics for diseases involving synaptic loss and dysfunction. Our drugs are designed to regenerate synapses to reverse declines in cognitive and motor function and fundamentally change treatment paradigms by restoring neuronal connections regardless of the underlying cause of synapse loss. Synapse loss is associated with a variety of neurological and psychiatric diseases, such as ALS, Alzheimer’s disease, Parkinson’s disease, and schizophrenia. More information on Spinogenix can be found at www.spinogenix.com

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