Canadian Veteran Dosed with First Cycle of APEX-90 Macrodose Psilocybin in Apex Labs' Early Access Program.

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Nov 02, 2023, 08:00 ET

Veteran patients have been successfully dosed with take home APEX-52 microdose and in-clinic APEX-90 macrodose drug assets, in each case under multi-dose protocols addressing moderate or severe depression and PTSD.

VANCOUVER, BC, Nov. 2, 2023 /PRNewswire/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin treatments is excited to announce the launch of its multi-dose Early Access Program (EAP) for APEX-90 macrodose psilocybin taken in-clinic with assisted psychotherapy. APEX's EAP supports physicians accessing psilocybin through Health Canada's Special Access Program (SAP) and will be rolled out to a select group of Canadian Veteran patients in 2023. The EAP is expected to expand dramatically in 2024 addressing the critical unmet need in depression and PTSD.

"First dosing with APEX-90 macrodose psilocybin obtained through the Early Access Program is a groundbreaking milestone for the company. We look forward to providing more Canadian Armed Forces and RCMP Veterans with APEX-90 supported by APEX's Therapy Manual. Access is now possible through APEX's clinical trials or Early Access Program where the stringent criteria of the Special Access Program are met," says Tyler Powell, co-Founder and Chief Executive Officer. "I am grateful to Health Canada for the continued support and could not be more proud of the APEX team for the years of hard work getting us here."

The Company supports EAP patients from program acceptance to dosing with long-term psychotherapy consistent with APEX's Investigator Brochure (IB) and Therapy Manual (TM). The inclusion of trained therapists, drug product and support team make this a unique and revolutionary patient care model.

Health Canada's SAP allows a physician to apply for authorization to receive APEX-90 psilocybin therapies that are not currently marketed or approved for sale in Canada.

"APEX's Early Access Program strictly follows the phase 2b protocol for the SUMMIT-90 clinical trial that was approved by Health Canada through a No Objection Letter, which has already screened approximately 100 patients for the trial," says Dr. Peter Tomlinson, co-Founder and Chief Technical Officer. "This program gives APEX the opportunity to collect real-world data in parallel with our clinical trial data which will help inform future phase 3 design."

About Early Access Program
The EAP supports physicians applying through Health Canada's SAP for access to the APEX-90 macrodose psilocybin product for treatment of patients suffering from severe disease states outside of clinical trials.

The EAP is specifically designed to support Canadian Armed Forces and RCMP Veterans, both populations that are disproportionately impacted by mental health conditions.

APEX's EAP is aligned with SUMMIT-90, a Health Canada approved phase 2b clinical protocol, while collecting Real-World Evidence (RWE).

About SUMMIT-90

SUMMIT-90 is a statistically powered multi-centre randomized, double-blind, placebo-controlled phase 2b study of a macrodose psilocybin drug asset approved by way of a No Objection Letter (NOL) from Health Canada received by APEX on April 14th, 2023. SUMMIT-90 evaluates multiple doses of APEX-90 macrodose psilocybin product administered in-clinic with assisted psychotherapy protocols under the APEX Therapy Manual for the treatment of severe depression in patients with diagnosed PTSD, recruiting 160 patients in Canada.

SUMMIT-90's primary indication being studied is severe depression within diagnosed PTSD, and secondary indications include standalone PTSD symptoms, chronic pain, and anxiety.

About Special Access Program
In Canada, the SAP allows physicians or certain other healthcare practitioners to access non-marketed or unauthorized drugs for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or unavailable. To obtain access, the healthcare practitioner must submit a request to Health Canada detailing the medical rationale for the use of the drug, after which, if approved, the drug can be acquired directly by the healthcare practitioner from the manufacturer or another supplier authorized by Health Canada.

About Apex Labs Ltd.
APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care with psilocybin treatments. By bringing data supported, clinically evaluated drugs to market for depression and anxiety in PTSD, APEX's strategy is focused on developing pharmaceutical products through phased clinical programs evaluating safety and efficacy across multiple indications, alongside a robust early access program.

APEX sees Veterans as a patient base with the most severe unmet need, supporting Veteran patients first and expanding to broader global patient communities.

Visit apexlabs.com for more information and follow APEX on LinkedIn, Twitter and Instagram

Forward-Looking Statement
This release contains certain "forward looking statements" and certain "forward-looking information" as defined under applicable Canadian securities laws. Forward-looking statements and information can generally be identified by the use of forward-looking terminology such as "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "continue", "plans" or similar terminology. Forward-looking statements and information are based on forecasts of future results, estimates of amounts not yet determinable and assumptions that, while believed by management to be reasonable, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause the Company's actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out here in, including but not limited to: Health Canada's CTA amendments, the Company evaluating the safety and efficacy of APEX-52 (psilocybin) and APEX-90 (psilocybin) in treating depression in Veterans and patients with Post-Traumatic Stress Disorder; statements related to APEX-52 and APEX-90, including manufacturing, dosing, and trial details; statements made by the Company's CEO and CTO with respect to the Company's efforts around the Early Access Program; statements made relating to Canadian Veteran patients using APEX-52 in the comfort of their own home and APEX-90 in-clinic; the potential impact of epidemics, pandemics or other public health crises, including the COVID-19 pandemic, on the Company's business, operations and financial condition, the successful integration of technology, the inherent risks involved in the general securities markets; uncertainties relating to the availability and costs of financing needed in the future; the inherent uncertainty of cost estimates and the potential for unexpected costs and expenses, currency fluctuations; regulatory restrictions, liability, competition, loss of key employees and other related risks and uncertainties. The Company undertakes no obligation to update forward-looking information except as required by applicable law. Such forward-looking information represents managements' best judgment based on information currently available. No forward-looking statement can be guaranteed and actual future results may vary materially. Accordingly, readers are advised not to place undue reliance on forward-looking statements or information.

SOURCE Apex Labs Ltd.