Apex Labs Ltd. a pharmaceutical company transforming the standard of mental health care with psilocybin is pleased to announce the approval by the Israeli MoH and IRBs to open two additional clinical trial sites for SUMMIT-90. The trial is a double-blind, placebo controlled phase 2b study evaluating multiple doses of APEX-90, a psilocybin macrodose utilizing APEX’s US patent pending capsule. APEX-90 is administered in-clinic with study-assisted psychotherapy for severe depression within diagnosed PTSD. Israel is facing a severe mental health crisis: 44% of adults report depression and 42% PTSD, far above the 8–13% depression and 6–10% PTSD rates seen in the US and Canada.
This MoH approval leverages the expertise of TAU’s renowned SGI and Merhavim Hospital, which both have a rich history of pioneering research in neurological sciences. Their cutting-edge facilities and teams profound understanding of PTSD dynamics are poised to add patient recruitment expertise.
“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,” says Sharon J. Fraenkel, TAU Canada’s CEO for Ottawa, Quebec, and Atlantic Canada, on behalf of the organization.
“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,” says 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. Through our incredible partnerships, we aim to catalyze a shift in access, care and outcomes for those suffering with PTSD.”
"SUMMIT-90 offers a beacon of hope for the significant numbers suffering from PTSD in Canada and Israel,” says 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.”
