Spinogenix Begins Phase 2 Trial for Schizophrenia Treatment SPG302

Spinogenix, Inc., a biopharmaceutical firm at the forefront of developing cutting-edge therapies to repair synapses and enhance patient wellbeing globally, has announced the commencement of a Phase 2 clinical trial for their innovative treatment, SPG302, targeting schizophrenia. With the endorsement from the Australia Human Research Ethics Committee (HREC), multiple sites are actively enrolling participants.

Schizophrenia affects around 24 million people globally. This intricate and severely disabling neuropsychiatric disorder manifests through three primary symptom categories: positive (hallucinations and delusions), negative (social withdrawal and anhedonia), and cognitive (memory and language deficits). Spinogenix is zeroing in on a critical aspect of schizophrenia's pathogenesis—a loss of excitatory synapses involving the neurotransmitter glutamate, which is believed to be a substantial factor in all symptom domains.

SPG302 is being developed as the first therapy aimed at regenerating synapses for schizophrenia, with the potential to significantly enhance patient outcomes across all symptom categories. Extensive data from various studies, including histological, imaging, and genetic research, indicate that the loss of glutamatergic synapses in the frontal cortex and other brain regions is a central feature of schizophrenia, contributing to psychosis, negative symptoms, and cognitive deficits. SPG302 works by rapidly regenerating these synapses through a novel mechanism.

The Phase 2 trial, which is randomized, double-blind, and placebo-controlled, aims to assess the efficacy, safety, and tolerability of SPG302, administered as a daily oral tablet to adults with a primary diagnosis of schizophrenia. Further details about this trial can be found on ClinicalTrials.gov under the identifier NCT06442462.

Dr. Stella Sarraf, CEO and Founder of Spinogenix, expressed enthusiasm about advancing a therapy capable of reversing synapse loss in schizophrenia, potentially representing a crucial breakthrough for patients with multiple symptoms and treatment-resistant forms of the disorder. She highlighted the limitations of current antipsychotics, which primarily target dopamine signaling and often fail to adequately manage psychosis or address negative and cognitive symptoms. SPG302, with its novel approach, could offer a significant improvement in treatment outcomes.

Supporting this perspective, Dr. Merv Turner, a member of Spinogenix’s Board of Directors, emphasized that targeting synapse loss represents a completely new therapeutic strategy. He mentioned that SPG302 could become a valuable addition to the range of schizophrenia treatments, especially following the anticipated introduction of KarXT, the first non-dopamine antipsychotic in 70 years.

SPG302 has already completed a Phase 1 safety study involving healthy subjects in Australia and has received U.S. FDA IND clearance for evaluation in ALS (Amyotrophic Lateral Sclerosis). Additionally, it has obtained HREC approval for a Phase 2 trial in Alzheimer’s disease. Detailed information on these trials can be found on ClinicalTrials.gov under the identifiers NCT05882695 and NCT06427668 respectively.

SPG302 is a daily pill designed to treat neurodegenerative and neuropsychiatric diseases by restoring synaptic connections, crucial for cognitive and motor functions. This first-in-class approach aims to reverse declines in cognitive, respiratory, and motor functions. The U.S. FDA has granted SPG302 Orphan Drug Designation for the treatment of ALS. The drug has also received preclinical support from the U.S. National Institutes of Health and the Department of Defense.

Schizophrenia, affecting 0.5-1% of the global population, is characterized by psychosis and a decline in daily functioning. Symptoms are categorized into positive (hallucinations, delusions), negative (social withdrawal, lack of emotion), and cognitive (memory deficits). Existing therapies often leave psychosis inadequately controlled and do little to address cognitive and negative symptoms.

Spinogenix is committed to developing transformative treatments for conditions involving synaptic loss or dysfunction. Their leading candidate, SPG302, aims to reverse synapse loss and improve functions in diseases like ALS, Alzheimer’s, and schizophrenia. They are also working on a therapeutic to enhance behavior in Fragile X Syndrome.