In the news release, Spinogenix Reports Early Improvements in Phase 2 Trial of Tazbentetol in Patients with Schizophrenia at the Schizophrenia International Research Society (SIRS) 2026 Annual Congress, issued 26-Mar-2026 by Spinogenix over PR Newswire, we are advised by the company that edits are required to the bulleted list in the second, third, and fourth bullet points. The complete, corrected release follows:
Spinogenix Reports Early Improvements in Phase 2 Trial of Tazbentetol in Patients with Schizophrenia at the Schizophrenia International Research Society (SIRS) 2026 Annual Congress
First-in-Class Synaptic Regenerative Therapy Demonstrates Favorable Safety Profile and Early Potential to Improve Symptoms of Schizophrenia
LOS ANGELES, March 26, 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 interim results from its Phase 2 trial evaluating tazbentetol (formerly SPG302) for the treatment of schizophrenia.
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).
Tazbentetol is a first-in-class investigational synaptic regenerative therapy with the potential to treat all three symptom domains of schizophrenia. The randomized, double-blind, placebo-controlled trial (NCT06442462) enrolled 32 adults with a primary diagnosis of schizophrenia to evaluate the safety, efficacy, tolerability and pharmacodynamics of tazbentetol. Enrolled patients received a daily oral dose of 300mg tazbentetol or placebo for six weeks.
Results from the prespecified interim analysis of 16 participants presented today at the Schizophrenia International Research Society (SIRS) 2026 Annual Congress demonstrated trends indicative of improvement in positive and negative symptoms and normalization of schizophrenia-related abnormalities in cortical activity:
- Favorable Safety Profile: Tazbentetol showed a favorable safety profile with no severe adverse events and was well tolerated by participants.
- Improvement in Overall Symptom Severity: Participants receiving tazbentetol showed greater reductions in PANSS total score compared to placebo (8 tazbentetol vs 8 placebo). Mean change from baseline was −11.9 versus −5.6 for placebo, representing a −6.3 point difference between groups at Day 71 (D71), indicating a durable effect following the six-week treatment period.
- Positive Symptom Improvements: An average -3.3 ±0.88 (mean ± SEM) point change from baseline in PANSS positive subscale score was observed in the tazbentetol group compared to -0.1 ± 0.66 points in placebo group, a -3.2 difference at D71. This treatment related improvement reached statistical significance at interim analysis (p=0.01).
- Negative Symptom Improvements: Mean PANSS negative subscale score changed -1.0 ± 0.65 from baseline for participants receiving placebo and -1.8 ± 0.77 for tazbentetol participants. The difference between groups was -0.8 at D71.
- Evidence of Drug Effect Based on EEG Biomarker Signals: Tazbentetol treatment was associated with significant improvements in schizophrenia-related EEG gamma band power abnormalities in occipital (p=0.011) and temporal (p=0.008) brain regions, and alpha band power abnormalities in occipital regions (p=0.002), in an eyes closed condition. Significant improvement of gamma power was also observed in central regions in an eyes open condition (p=0.042).
"These results showcase the possibility for synaptic regeneration to shift our treatment approach in schizophrenia," said Dr. David Walling, PhD, Chief Clinical Officer at CenExel and Principal Investigator of the trial, who has been involved in schizophrenia drug development for over 30 years. "This study provides important preliminary clinical support for the role of synapse loss in the genesis of schizophrenia symptoms, with regeneration offering an intervention potentially impacting all symptom domains. I am eager to see continued promising data, including EEG analysis, as the trial progresses."
The study's primary and secondary endpoints included 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).
"We are encouraged by these results and the early evidence that tazbentetol can address an unmet treatment need in schizophrenia," said Dr. Stella Sarraf, CEO and Founder of Spinogenix. "Alongside our trials assessing tazbentetol in Alzheimer's disease and ALS, this latest data adds to the indicators that a regenerative approach can make a difference to patients, refocusing treatment on the structural causes of neurological disease – synapses."
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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