Drug Development

1

GMP API

APEX leverages multiple lab partners across Canada and the US ensuring supply chain stability to manufacture its Active Pharmaceutical Ingredients (API) under Good Manufacturing Practices (GMP)assisting in cross-border transportation. APEX has completed significant research and development to formulate a unique capsule for use in clinical trials and the Early Access Program.

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 drug products used in upcoming clinical trials and medical access.

Clinical Pipeline

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

APEX-52 microdose take home treatment

Potential to be optimized for moderate disease severity.

    1. STEP-52 Risk mitigation study completed: First patient with PTSD dosed with APEX-52 in take home microdose phase 2b stability study in January 2023. The trial completed March 29th 2023 and met all endpoints with no adverse events.
    2. World largest take home psilocybin clinical trial (PATHFINDER-52) approved by Health Canada January 2023. Phase 2b double-blind, placebo controlled clinical study to evaluate safety, efficacy and tolerability, recruiting 294 patients and beginning Q3 2024.

APEX-90 macrodose drug for in-clinic dosing with assisted psychotherapy

Potential to be optimized for severe disease. 

  • SUMMIT-90 statistically powered 160 patient macrodose phase 2b clinical trial using APEX-90 drug product approved by Health Canada April 14th 2023. Pre-screening completed and trial launch Q2 2024.
  • Early Access Program began dosing Veteran patients in 2023 to provide treatment to patients with highest immediate unmet need outside of clinical trials

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 enrolment and our Early Access Program.

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

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 Special Access Program (SAP) which now includes psilocybin and MDMA. 

In addition to the clinical program APEX has begun an EAP for Canadian Armed Forces and RCMP Veterans, leveraging Canada’s SAP program for the APEX-90 macrodose drug candidate which has already begun. APEX-52 also to be eligible for SAP program following positive data from phase 2b trial.APEX received approval by Health Canada for it’s Dealer’s Licence to sell psilocybin through the SAP in 2024.

The APEX EAP achieves two primary objectives:

  1. Broader access to emerging therapeutic treatments where the current standard of care has failed
  2. The generation of revenue while facilitating the collection of real world evidence to further support our clinical program under strict physician oversight
  3. Provide the most vulnerable patients in need access to APEX-90 outside of clinical trials

APEX has access to thousands of Veteran patients, 15 Veteran focused clinics, and psilocybin trained therapists.

SAP Experience

Kelsi Sheren, a Canadian Armed Forces Veteran who was approved through the SAP and dosed with APEX-90 October 2023 highlights her experience:

“Every Veteran matters but we are often left behind. I have been following existing standards of care for my depression and PTSD for a decade, and it just hasn’t been enough. I am grateful to the APEX team and my physician for moving this forward and hope more Veterans like me will gain access.”

APEX was part of the first psilocybin SAP Health Canada approval in Q1 2022, supporting six patients. This is the first legal medical access to psilocybin outside of a clinical trial in Canadian history.

“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.” – Therapsil Media Release