Israel’s Health Ministry Approves Expansion of Apex Labs’ Phase 2b Psilocybin Trial for PTSD

LOS ANGELES- Apex Labs Ltd. has secured approval from Israel’s Ministry of Health (MoH) and relevant ethics boards to expand its ongoing Phase 2b SUMMIT‑90 clinical trial assessing macrodose psilocybin therapy (APEX‑90) for post-traumatic stress disorder (PTSD). The company will add two new sites: Tel Aviv University’s Institute for Psychedelic Research at the Sagol Brain Institute (Tel‑Aviv Sourasky Medical Center) and the Center for Psychedelic Studies at Be’er Yaakov Mental Hospital .

The SUMMIT‑90 trial is a randomized, double-blind, placebo-controlled study involving 160 participants. It evaluates multiple doses of APEX‑90, administered in conjunction with psychotherapy, targeting individuals suffering from severe depression associated with PTSD . The trial’s expansion aims to leverage the new sites’ advanced facilities and expertise, enhancing patient recruitment in region experiencing elevated PTSD and depression rates—44 % and 42 %, respectively, compared with roughly 6–10 % PTSD and 8–13 % depression rates in North America .

Apex Labs emphasizes its patient-focused approach, noting the strategic expansion “marks a fundamental step towards transforming the mental health landscape in Canada and Israel” . Israeli public health experts have welcomed the move, calling it “an important step in the right direction”.

The inclusion of these highly regarded research institutions reflects Apex’s commitment to advancing psychedelic-assisted treatments with rigorous protocols. The added participants are expected to strengthen the trial’s dataset, supporting future regulatory decisions and potential commercialization of psilocybin-based therapies for PTSD.