US-based biopharmaceutical company Spinogenix has concluded the enrolment of patients in its Phase II clinical trial of tazbentetol (previously known as SPG302), a synaptic regenerative treatment for schizophrenia.
The placebo-controlled, double-blind, randomised trial is designed to evaluate tazbentetol’s efficacy, safety, tolerability, and pharmacodynamics in adults diagnosed with schizophrenia.
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It included 32 adult patients who will receive a daily oral dose of either tazbentetol or a placebo for a period of six weeks.
Spinogenix plans to share interim results at the Schizophrenia International Research Society Annual Congress in Florence, Italy, from 26 to 29 March 2026.
Schizophrenia is characterised by positive symptoms such as hallucinations and delusions, as well as negative and cognitive symptoms. Current antipsychotics mainly address positive symptoms, leaving other domains under-treated.
The primary and secondary endpoints include changes in symptom severity measured by the Positive and Negative Syndrome Scale (PANSS) score and in clinical global impression of improvement (CGI-I).
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By GlobalDataThe study also integrates electroencephalogram (EEG) analysis as a neurophysiological biomarker sensitive to synaptic density, along with the use of the Matrics consensus cognitive battery (MCCB).
Spinogenix founder and CEO Dr Stella Sarraf said: “Attaining full enrolment in this Phase II trial is a critical step in our mission to offer a new treatment option for the millions of people living with schizophrenia.
“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.”
In February 2025, Spinogenix reported top line outcomes from a Phase II trial of SPG601 for treating Fragile X syndrome (FXS), a genetic disorder linked to autism and intellectual disability, in adult male patients.
The randomised, placebo-controlled study compared a single dose of the therapy with a matching placebo in ten adult men with core attributes of FXS.
