Spinogenix Completes Enrollment in Phase 2 Clinical Trial of Tazbentetol for Schizophrenia Treatment

First-in-Class Synaptic Regenerative Therapy Aims to Address Positive, Negative and Cognitive Symptom Domains

Oral Presentation on Interim Data Planned for Schizophrenia International Research Society (SIRS) Annual Congress

LOS ANGELES, March 11, 2026 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced completion of patient enrollment in its Phase 2 trial of tazbentetol (formerly SPG302) for the treatment of schizophrenia. The company will announce interim results from the trial at the upcoming Schizophrenia International Research Society (SIRS) 2026 Annual Congress in Florence, Italy, March 26-29.

Tazbentetol is a first-in-class synaptic regenerative investigational treatment with the potential to treat all three symptom domains of schizophrenia. The randomized, double-blind, placebo-controlled trial (NCT06442462) enrolled 32 patients and is evaluating the safety, efficacy, tolerability, and pharmacodynamics of tazbentetol in adults with a primary diagnosis of schizophrenia. Enrolled patients receive a daily oral dose of tazbentetol or placebo for six weeks.

"Attaining full enrollment in this Phase 2 trial is a critical step in our mission to offer a new treatment option for the millions of people living with schizophrenia," said Dr. Stella Sarraf, CEO and Founder of Spinogenix. "We are excited to complete this trial designed to establish the potential of a synaptic regenerative therapy to address the positive symptoms of schizophrenia, and to improve negative and cognitive symptoms that remain largely unaddressed by standard of care medications."

Schizophrenia, a complex and debilitating psychiatric disorder, is characterized by three symptom domains: positive symptoms (including hallucinations and delusions), negative symptoms (social withdrawal, anhedonia and lack of motivation) and cognitive symptoms (memory, attention and language deficits). Current antipsychotics only manage effectively positive symptoms, leaving negative and cognitive symptoms largely untreated.

Dr. David Walling, PhD, Chief Clinical Officer at CenExel and Principal Investigator of the trial, who was previously involved in the clinical evaluation of Cobenfy as the first non-dopaminergic antipsychotic, added, "Tazbentetol brings a potentially important new mechanism of action to the field and has the potential to shift the treatment paradigm towards regenerative medicine, in essence brining back a key component of what has been lost at a structural level in the disease - synapses. I look forward to presenting topline data from the tazbentetol trial at the upcoming SIRS 2026 Annual Congress."

The primary and secondary endpoints of the ongoing trial include change in symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS Score) and change in the Clinical Global Impression of Improvement (CGI-I). As in other indications where tazbentetol is being clinically tested, the ongoing schizophrenia trial integrates EEG analysis as an objective and quantitative neurophysiological biomarker that is sensitive to synaptic density. Changes in schizophrenia-related EEG abnormalities at rest and in response to stimuli provide valuable additional insights into pharmacodynamic activity. Additionally, the MATRICS Consensus Cognitive Battery (MCCB) is being used to evaluate improvements in cognitive functioning through timed assessments.

About Spinogenix 

Current treatments for neurodegenerative, neuropsychiatric and neurodevelopmental conditions primarily focus on slowing disease progression or minimizing symptoms, leaving many without hope for improvement. Spinogenix is aiming to transform the treatment of these conditions through its pioneering first-in-class and paradigm-shifting synaptic regenerative and synaptic corrective therapeutics designed to restore depleted synapses and reverse synaptic degeneration and dysfunction.

Spinogenix is developing two novel therapeutics: Tazbentetol (formerly SPG302), which is designed to trigger neurons to produce new glutamatergic synapses and restore cognitive, motor, and other functions in ALS, Alzheimer's disease, schizophrenia and other diseases; and SPG601, which is designed to work at the synaptic level to correct specific dysfunctions in Fragile X Syndrome (FXS) that underlie many core symptoms. The company has received FDA and EMA Orphan Drug designations for ALS as well as FDA and EMA Orphan Drug and FDA Fast Track designations for FXS. More information on Spinogenix can be found at www.spinogenix.com or follow us on LinkedIn. 

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FINN Partners
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Investor Relations 
Dan Albosta
Spinogenix, Inc.
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SOURCE Spinogenix