Apex Labs Ltd. received approval from Israel’s Ministry of Health to expand its phase 2b clinical trial, SUMMIT-90, for APEX-90, a psilocybin-based treatment for severe depression in individuals diagnosed with PTSD. The two new sites are Tel Aviv University’s Institute for Psychedelic Research at the Sagol Brain Institute and the Be’er Yaakov Mental Hospital’s Center for Psychedelic Studies. This expansion is driven by the significant mental health crisis in Israel, with depression and PTSD rates substantially higher than in North America.
The inclusion of these respected Israeli institutions in the SUMMIT-90 trial is crucial. Leveraging the expertise of Tel Aviv University and Be’er Yaakov Mental Hospital, known for their advanced facilities and deep understanding of PTSD, should enhance patient recruitment and generate robust, region-specific data regarding the efficacy of APEX-90. This collaboration represents a significant cross-border effort to address a pressing mental health need.
This expansion builds upon APEX’s ongoing phase 2b clinical trial, evaluating multiple doses of its patent-pending psilocybin capsule, APEX-90, combined with psychotherapy. The focus on PTSD within the trial underscores the company’s dedication to addressing complex mental health conditions and potentially offers a novel therapeutic approach for a patient population often resistant to traditional treatments.
This approval marks a crucial step for Apex Labs in its mission to advance psilocybin-based therapies. The collaboration with Israeli institutions not only accelerates the clinical development of APEX-90 but also positions the company to potentially access a significant patient population experiencing high rates of PTSD and depression. The data gathered from these new trial sites will be instrumental in understanding the treatment’s effectiveness and could pave the way for future regulatory approvals and broader access to this promising therapy.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
