Drug Development

1

GMP API

APEX leverages multiple lab partners across Canada and the US ensuring supply chain stability to manufacture its API under Good Manufacturing Practices (GMP) including all supporting Chemistry, Manufacturing, and Controls (CMC) data and completing the Quality Overall Summary (QOS) for patient consumption.

2

Research & Development

Dr. Orion Lekos oversees Research and Development (R&D) alongside Dr. Bal Kang to lead exploration of Intellectual Property (IP) formulations for APEX’s synthetic psilocybin-derived drug products used in upcoming clinical trials and medical access.

Drug Asset Optimization

There is not one size-fits all when it comes to psilocybin therapies. Some patients are best suited to in-clinic macro-dose treatments with assisted psychotherapy, while others are best suited for take-home microdose psilocybin treatment options. 

APEX’s two unique drug assets have the potential to be optimized for severity across indications, supporting unmet need in many patient cohorts.

APEX-52 microdose take-home treatment

Potential to be optimized for mild to moderate disease severity.

    1. Risk mitigation study near completion: First patient with PTSD dosed with APEX-52 in take-home microdose phase 2b stability study (STEPS-52) in January 2023, results expected Q2 2023.
    2. World largest take-home psilocybin clinical trial (PATHFINDER-52) approved by Health Canada January 2023, recruiting Q2 2023. Phase 2b double-blind, placebo controlled clinical study to evaluate safety, efficacy and tolerability, recruiting 294 patients. 

APEX-90 macro-dose drug for in-clinic dosing with assisted psychotherapy

Potential to be optimized for severe disease. 

  • SUMMIT-90 CTA submitted March 20th, 2023 for statistically powered 160 patient macro-dose phase 2b clinical trial using APEX-90 drug product 
  • Robust Early Access Program to provide treatment to patients with highest immediate unmet need 

Patient Recruitment

The best way to optimize clinical trial costs, speed and outcomes is to expedite recruitment to the most qualified patient candidates. 

A Veteran-First Approach

As a Veteran-founded organization and in alignment with our mission to address the highest areas of unmet need, APEX’s research team will be initially focused on Veteran communities in trial recruitment who have the most severe mental health disease burden. APEX has access to a network of thousands of Canadian Armed Forces and RCMP Veteran patients and strong relationships with Veteran-focused practitioners sufficient to support swift clinical trial enrollment and our Early Access Program.

APEX aims to secure clinical indications for the general population, including Veterans. 

Macro-Dose Early Access Program

The strategy behind early access is to provide the most vulnerable patients in need access to a medication prior to full-commercial approval. 

Currently the primary mechanism through which Health Canada allows psilocybin access to patients is the recently revised Special Access Program (SAP) which now includes psilocybin and MDMA. 

In addition to the clinical development program, APEX Labs is pursuing an Early Access Program for Canadian Armed Forces and RCMP Veterans leveraging Canada’s SAP program for the APEX-90 macro-dose drug candidate.

The APEX Labs EAP will achieve two primary objectives: 

  1. Broader access to emerging therapeutic treatments where the current standard of care has failed 
  2. The generation of pre-DIN revenue while facilitating the collection of real-world evidence to further support our clinical program under strict physician oversight 

SAP Experience

On March 21st, 2022, Dr. Valorie Masuda MD received authorization under the SAP to treat six patients experiencing end-of-life distress with psilocybin and psychotherapy. GMP synthetic psilocybin was donated by Psygen Labs Inc., and Apex Labs Ltd. provided access to its psilocybin investigators’ brochure, in support of the SAP application. This is the first known case of psilocybin being accessed through Canada’s SAP since the Food and Drug Regulations were amended on January 5th, 2022, to allow access to psilocybin and other restricted drugs through the SAP. The six patients were treated in early April of 2022 by Roots to Thrive, co-led by Dr. Masuda.

This is the first legal medical access to psilocybin outside of a clinical trial in Canadian history.