Execute multiple clinical programs evaluating safety and efficacy of APEX drug assets for PTSD and depression in Canada, the US and Israel.

Commercial Strategy

Psilocybin has been studied in clinical trials to explore its clinical value in mental health. It remains a controlled substance, not approved for general medical use by Health Canada, and is only available under specific, controlled circumstances. APEX is currently evaluating two unique psilocybin drug assets seeking commercial approval optimized for all relevant disease states: 

• APEX-52 microdose drug candidate optimized for take home dosing targeting moderate disease severity
• APEX-90 macrodose drug candidatem positioned for in-clinic dosing with assisted psychotherapy focused on severe disease
• Veteran patients have been dosed with both drug assets meeting all endpoints with no adverse events

Regulatory Strategy

Following our Canadian phase 2b study completion in Canada APEX will pursue phase 3 trials and commercial approval. In parallel, APEX is evaluating and pursuing clinical development and commercial approval for the US, Israeli, EU and Australian markets. 

Patient Focus

Trauma and PTSD are growing global problems affecting diverse populations with Veterans facing PTSD at higher rates, published by Veteran Affairs organizations in multiple countries.

As a Veteran-founded organization, APEX is seeking indications for the general population and will prioritize Veteran patient communities that represent very high unmet need in clinical trial recruitment. APEX will leverage access to a network of thousands of Veteran patients and strong relationships with Veteran-focused practitioners to expedite recruitment to the most qualified patient candidates.