Spinogenix Launches Phase II Trial for Synaptic Regenerative Therapy in Schizophrenia

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Spinogenix announced open enrollment for its Phase II trial of SPG302, the first synaptic regenerative therapy for schizophrenia. According to the company, the launch of the Phase II trial comes amid the FDA’s clearance of an Investigational New Drug Application for the treatment. The trial, which will be conducted in the United States, is expected to build on trials currently in progress in Australia.¹

"We are thrilled at the possibility of bringing an entirely new approach to treating schizophrenia for people battling this disorder in the United States,” said Stella Sarraf, CEO, founder, Spinogenix, in a press release. “Synaptic regeneration may improve the standard of care in schizophrenia and potentially help those who do not benefit from current medications."

The randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SPG302 in approximately 32 adults with schizophrenia in the United States and Australia. All participants will attend weekly screenings and receive medication for home use.^1,2

Recent advances in schizophrenia treatment include the FDA’s September 2024 approval of Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride), marking the first new class of medication for schizophrenia in over 30 years. However, current treatments primarily target dopamine pathways and focus on managing positive symptoms, often leaving negative and cognitive symptoms unaddressed. SPG302 aims to fill this gap by targeting glutamatergic synapse loss, a key contributor to all symptom domains.³

Schizophrenia affects approximately 24 million people globally, with a prevalence of one out of every 222 adults, according to the World Health Organization (WHO). In the United States, prevalence is estimated to be between 0.25% to 0.64%. While the disorder can first occur at any age, it is most common between late adolescence to the early 20s for men and between the late 20s to early 30s for women. For patients under 12 years of age or over 40 years of age, diagnosis is uncommon. WHO statistics indicate that while approximately 50% of all patients in mental health hospitals have schizophrenia, only 31.3% of people with the disorder receive specialist mental health care.^4,5

"To date, no treatments are approved to address negative symptoms and cognitive dysfunction associated with schizophrenia," said Christoph Correll, MD, professor of psychiatry, molecular medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, leading researcher on the cognitive and negative symptoms of schizophrenia, in the press release. "Since a loss of glutamatergic synapses in the frontal cortex and in other key regions may be crucial to the pathophysiology of schizophrenia, there is a potential for SPG302 to improve positive, negative, as well as cognitive symptoms in people living with schizophrenia. The reparative aspect of neuronal regeneration may lend itself to early illness interventions as well as to interventions for people with treatment-resistant schizophrenia for whom currently only clozapine is approved."

SPG302 is a once-daily oral therapy designed to restore synapses, the neural connections essential for cognitive, motor, and respiratory function. As a first-in-class regenerative treatment for neurodegenerative and neuropsychiatric diseases, Spinogenix believes that it has the potential to improve functional outcomes. The treatment has also received an Orphan Drug Designation for ALS and has received preclinical support from the National Institutes of Health and the Department of Defense.¹

References

1. Spinogenix Announces Open Enrollment for Phase 2 US Trial Following FDA Clearance of IND Application for SPG302, the First Synaptic Regenerative Therapy for Schizophrenia. PR Newswire. March 31, 2025. Accessed April 3, 2025. https://prnmedia.prnewswire.com/news-releases/spinogenix-announces-open-enrollment-for-phase-2-us-trial-following-fda-clearance-of-ind-application-for-spg302-the-first-synaptic-regenerative-therapy-for-schizophrenia-302415491.html
2. Study of SPG302 in Adults With Schizophrenia. Clinicaltrials.gov. Accessed April 3, 2025. https://www.clinicaltrials.gov/study/NCT06442462?term=spinogenix&rank=2
3. FDA Approves Bristol Myers Squibb’s Cobenfy for Schizophrenia. PharmExec. September 27, 2024. Accessed April 3, 2025. https://www.pharmexec.com/view/fda-approves-bristol-myers-squibb-cobenfy-schizophrenia
4. Schizophrenia. NAMI. Accessed April 3, 2025. https://www.nami.org/about-mental-illness/mental-health-conditions/schizophrenia/#:~:text=It%20is%20a%20complex%2C%20long,to%200.64%25%20of%20U.S.%20adults.
5. Schizophrenia. WHO. Accessed April 3, 2025. https://www.who.int/news-room/fact-sheets/detail/schizophrenia