Spinogenix, Inc. has announced the launch of a Phase 2 clinical trial evaluating SPG302 as a novel treatment for schizophrenia. The trial, which has received approval from the Australia Human Research Ethics Committee (HREC), is currently enrolling participants at multiple sites.
SPG302 is a first-in-class therapeutic designed to restore synapses, the connections between neurons, and represents a novel approach to treating schizophrenia by addressing synapse loss, a key feature of the disease.
Targeting Synapse Loss in Schizophrenia
Schizophrenia, affecting approximately 24 million people worldwide, is characterized by positive symptoms (hallucinations, delusions), negative symptoms (social withdrawal, anhedonia), and cognitive deficits (memory and language deficits). Spinogenix is focusing on the loss of excitatory glutamatergic synapses as a major contributor to these symptoms.
"We are excited to advance the first clinical therapy capable of reversing synapse loss in schizophrenia, which may provide a much-needed advancement in the treatment of multiple symptoms and patients who are treatment resistant," said Dr. Stella Sarraf, CEO and Founder of Spinogenix.
SPG302: A Synaptic Regenerative Approach
SPG302 is being developed as the first synaptic regenerative therapy for schizophrenia. Preclinical data suggest that SPG302 rapidly regenerates glutamatergic synapses through a novel mechanism of action, potentially improving patient outcomes across all symptom domains.
The Phase 2 study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy, safety, and tolerability of SPG302 administered once-daily as an oral tablet in adults with a primary diagnosis of schizophrenia. Additional information on the Phase 2 trial is available on ClinicalTrials.gov (NCT06442462).
Addressing Unmet Needs in Schizophrenia Treatment
Current antipsychotics primarily target dopamine signaling to control positive symptoms but often leave psychosis inadequately controlled and have limited benefit on negative and cognitive symptoms. SPG302 offers a new approach by directly targeting synapse loss.
"The synaptic regenerative approach being championed by Spinogenix may add an important new option to the armamentarium of drugs available to those battling schizophrenia," said Dr. Merv Turner, a member of the Spinogenix Board of Directors. "While long believed to be of potential benefit, targeting synapse loss in practice represents an entirely new therapeutic strategy."
SPG302's Broader Potential
SPG302 has completed a Phase 1 safety study in healthy subjects in Australia and has U.S. FDA IND clearance for evaluation of ALS. It has also received HREC approval for a Phase 2 trial in Alzheimer’s disease, highlighting its potential in treating various neurodegenerative and neuropsychiatric conditions.
