Policy & Regulation
Spinogenix starts enrolment for SPG302 Phase 2 trial in schizophrenia
1 April 2025 -

Clinical-stage biopharmaceutical company Spinogenix Inc announced on Monday that it has commenced enrolment for a Phase 2 trial of SPG302 intended for the treatment of people with schizophrenia.

This follows approval of the company's Investigational New Drug (IND) application by the US Food and Drug Administration (FDA).

Designed to assess the efficacy, safety and tolerability of once-daily dosing of SPG302, the US trial expands on studies underway in Australia. SPG302, a once-a-day pill, is being developed as a regenerative treatment for neurodegenerative and neuropsychiatric diseases with the unique ability to restore synapses.

Spinogenix CEO and founder Dr. Stella Sarraf said: "We are thrilled at the possibility of bringing an entirely new approach to treating schizophrenia for people battling this disorder in the United States. Synaptic regeneration may improve the standard of care in schizophrenia and potentially help those who do not benefit from current medications."

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