Apex Labs Ltd. has secured approval from Israel's Ministry of Health to expand its phase 2b clinical trial evaluating psilocybin therapy for post-traumatic stress disorder (PTSD), adding two prominent Israeli medical institutions to the SUMMIT-90 study. The expansion comes as Israel grapples with unprecedented mental health challenges, with 44% of adults reporting depression and 42% experiencing PTSD—rates far exceeding the 8-13% depression and 6-10% PTSD prevalence seen in the United States and Canada.
Trial Design and Patient Population
The SUMMIT-90 study is a double-blind, placebo-controlled phase 2b trial designed to evaluate multiple doses of APEX-90, the company's proprietary psilocybin macrodose formulation delivered via a US patent-pending capsule. The 160-patient study administers the investigational therapy in-clinic alongside study-assisted psychotherapy specifically for patients with severe depression within diagnosed PTSD.
The newly approved Israeli sites include Tel Aviv University's Institute for Psychedelic Research, located at the Sagol Brain Institute within Tel-Aviv Sourasky Medical Center, and Be'er Yaakov Mental Hospital's Center for Psychedelic Studies. Both institutions bring extensive expertise in neurological sciences and PTSD research to the trial.
Strategic Partnership and Clinical Rationale
"As someone deeply connected to Israel, witnessing the toll of PTSD among my loved ones, I'm driven to lead research that brings hope and healing," said Alysa Langburt, Apex's VP of Global Clinical Development. "This marks more than a clinical milestone, it represents a fundamental step towards transforming the mental health landscape in Canada and Israel, where the need has never been greater."
The partnership leverages the specialized expertise of both Israeli institutions, which have established reputations in pioneering neurological research. Their advanced facilities and deep understanding of PTSD dynamics are expected to enhance patient recruitment capabilities for the trial.
Company Focus and Veteran Population
Apex Labs positions itself as a patient-driven pharmaceutical company focused on revolutionizing mental health care through psilocybin therapies. The company's dual strategy encompasses clinical evaluation of drug assets alongside a robust Early Access Program, with particular emphasis on serving Veterans as a patient population with severe unmet medical needs.
"SUMMIT-90 offers a beacon of hope for the significant numbers suffering from PTSD in Canada and Israel," stated Tyler Powell, co-founder and CEO of Apex. "It underscores our commitment to global mental health innovation and our belief in the opportunity for clinically proven psilocybin therapies to transform mental health care."
Regulatory Pathway and Access
The Israeli Ministry of Health approval represents a significant regulatory milestone for the company's international expansion strategy. Patients interested in participating can access trial information through clinicaltrials.gov for Canadian sites and mytrials.gov for Israeli locations.
Sharon J. Fraenkel, CEO of TAU Canada for Ottawa, Quebec, and Atlantic Canada, emphasized the collaborative nature of the initiative: "I am honoured to have been able to facilitate this new partnership; another example of building important bridges between Canada and Israel in innovative clinical research, which will result in advancing patient access to emerging treatments."
