Phase 2 trial is designed to evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia

LOS ANGELES, Calif., September 25, 2024 — Spinogenix, Inc., a clinical-stage biopharmaceutical
company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced that with the approval of the Australia Human Research Ethics Committee (HREC), multiple sites are currently enrolling participants in a Phase 2 clinical trial to evaluate SPG302 as a novel treatment for schizophrenia.

Approximately 24 million people worldwide suffer from schizophrenia, a complex and highly debilitating neuropsychiatric disorder characterized by a trio of symptom domains: positive (e.g. hallucinations, delusions), negative (e.g. social withdrawal, anhedonia) and cognitive (e.g. memory and language deficits). Spinogenix is focused on addressing a key feature of schizophrenia pathogenesis that may be a major contributor to all symptom domains: a loss of excitatory synapses that use the amino acid glutamate as a neurotransmitter (i.e. glutamatergic synapses).

Spinogenix is developing SPG302 as the first synaptic regenerative therapy for schizophrenia, with the potential to improve patient outcomes in all symptom domains. A wealth of data from histological, imaging, genetic and other studies implicate a loss of glutamatergic synapses in frontal cortex and other regions as a primary feature of schizophrenia pathogenesis, contributing to the onset of psychosis, negative symptoms and cognitive deficits ₁ . SPG302 rapidly regenerates glutamatergic synapses through a novel mechanism of action. Spinogenix has initiated a randomized, double-blind, placebo-controlled multicenter Phase 2 study to assess the efficacy, safety, and tolerability of SPG302 administered once-daily as an oral tablet in adults with a primary diagnosis of schizophrenia. Additional information on the Phase 2 trial is available on ClinicalTrials.gov (NCT06442462).

“We are excited to advance the first clinical therapy capable of reversing synapse loss in schizophrenia, which may provide a much-needed advancement in the treatment of multiple symptoms and patients who are treatment resistant,” stated Dr. Stella Sarraf, CEO and Founder of Spinogenix. “Antipsychotics targeting dopamine signaling have been used since the 1950s to control positive symptoms, but leave psychosis inadequately controlled in many patients and have little benefit on negative and cognitive symptoms. As demonstrated by the expected entry of promising emerging antipsychotics into the schizophrenia treatment landscape, we are at an inflection point where new targets and novel approaches like SPG302 represent our best option to show meaningful improvements for this population.”

Dr. Merv Turner, a member of the Spinogenix Board of Directors, shared, “The synaptic regenerative approach being championed by Spinogenix may add an important new option to the armamentarium of drugs available to those battling Schizophrenia. While long believed to be of potential benefit, targeting synapse loss in practice represents an entirely new therapeutic strategy. SPG302 has the potential to become another novel and high-value addition to the schizophrenia therapeutics space, following the expected entry of KarXT as the first non-dopamine antipsychotic in 70 years.”

SPG302 has completed the Phase 1 safety study in healthy subjects in Australia and has U.S. FDA IND clearance for evaluation of ALS. SPG302 also received HREC approval for a Phase 2 trial in Alzheimer’s disease. Additional information on the ALS trial (NCT05882695) and Alzheimer’s disease trial (NCT06427668) may be found on ClinicalTrials.gov.

About SPG302
SPG302 is a once-a-day pill being developed as a regenerative treatment for neurodegenerative
and neuropsychiatric diseases with the unique ability to restore synapses, the key connections between neurons that allow people to think, plan, remember, and control motor functions. The synaptic regenerative activity of SPG302 represents a first-in-class approach to treating these diseases and has the potential to reverse declines in cognitive, respiratory, and motor function. SPG302 has been granted U.S. FDA Orphan Drug Designation for the treatment of ALS. Additional information on the clinical trials evaluating SPG302 can be found on ClinicalTrials.gov (NCT05882695 and NCT06427668). SPG302 has received preclinical support from the U.S. National Institutes of Health and the Department of Defense.

About Schizophrenia
Schizophrenia is a highly prevalent (0.5-1% of the population world-wide) and chronic psychiatric disorder associated with psychosis and a decline in daily functioning. Individuals with schizophrenia present with both positive and negative symptoms, as well as cognitive deficits. Positive symptoms include hallucinations, delusions, disorganized speech and abnormal movements, whereas negative symptoms include social withdrawal, anhedonia, apathy and lack of emotion. Together with co-morbid cognitive deficits, these symptoms have a major impact on the overall quality of life. Despite the availability of many drug therapies, psychosis in many patients remains inadequately controlled and both cognitive and negative symptoms are largely unaddressed.

About Spinogenix
Spinogenix is dedicated to developing transformative therapeutics for conditions involving the loss or dysfunction of synapses. Our lead clinical-stage synaptic regenerative candidate is a first-in-class therapeutic designed to reverse synapse loss and improve cognitive and motor functions in neurodegenerative and neuropsychiatric diseases such as ALS, Alzheimer’s disease, and schizophrenia. In parallel, we are also developing a synaptic function therapeutic designed to improve behavior in Fragile X Syndrome. More information on Spinogenix can be found at www.spinogenix.com or follow us on LinkedIn.

Reference

1. Howes OD, Onwordi EC. The synaptic hypothesis of schizophrenia version III: a master mechanism. Mol Psychiatry. 2023 May;28(5):1843-1856. doi: 10.1038/s41380-023-
   02043-w. Epub 2023 Apr 11. PMID: 37041418; PMCID: PMC10575788.

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