Report champions expansion of early access and funding for Canadian Veterans.
VANCOUVER, BC, Nov. 17, 2023 /PRNewswire/ – Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin treatments commends the Senate Subcommittee on Veteran Affairs for their groundbreaking report “The Time Is Now: Granting equitable access to psychedelic-assisted therapies.” Following months of hearings and consultation, the Subcommittee specifically calls for “immediate implementation of a robust research program funded by Veterans Affairs Canada (VAC) and the Department of National Defence (DND).” APEX is proud to see our Early Access Program (EAP) and clinical pipeline mentioned in the report, supporting the Subcommittee’s process.
Dr. Mark Johnston, Chief Medical Officer at APEX, emphasizes the urgency of the situation.” The current approach to treating Post Traumatic Stress Disorder (PTSD) in Veterans is failing and the negative outcomes from the current standard of care in PTSD are putting patients’ lives at risk.
The Subcommittee’s recommendations echo the urgent, dire clinical need for effective treatments. Psychedelic-assisted therapy offers a promising, evidence-based avenue to significantly improve mental health care for Veterans. It’s time to expand our therapeutic tools to include these potentially transformative treatments.”
As noted in the report, it is estimated that upwards of 15% of Canadian Veterans have been diagnosed with PTSD and are impacted by suicide at a substantially higher rate than the general population. Antidepressants paired with psychotherapy are the current standard of care in PTSD, but the report highlights limited efficacy and distressing side effects in approved drugs.
“The Special Access Program (SAP) offers a crucial pathway for Veterans who have exhausted all other options,” adds Dr. Johnston. “APEX urges a swift expansion of access under the SAP, ensuring Veterans eligible for the program receive the same benefits and insurance coverage as they would for traditional PTSD treatments.”
The Subcommittee emphasizes why it is essential for private companies and public institutions to prioritize and invest in Veteran mental health, as highlighted in the report’s conclusion below:
“We owe it to our Veterans to explore every possibility. They should not be left to explore these options on their own. The entire hierarchy of the Canadian Armed Forces, of the Royal Canadian Mounted Police, every employee at Veterans Affairs Canada and the entire Government of Canada, plus whatever researchers and health care professionals that the government can mobilize, should tackle this issue without hesitation. These Veterans are suffering because they rose to the highest calling of our nation. In return, Canadian decision-makers should do everything in their power, explore every avenue, leave no stone unturned, in case even one is hiding a wisp of a solution that could help them improve their daily lives. Let’s tackle this problem with all available resources, motivated by their despair. What could be more important than that?”
The APEX EAP supports physicians applying through Health Canada’s SAP for access to the APEX-90 macrodose psilocybin product for treatment outside of clinical trials where patients are suffering from severe disease states and otherwise meet the criteria for the SAP.
A physician recently used APEX-90 drug product to dose a Canadian Veteran patient using APEX’s Therapy Manual for assisted psychotherapy guidance.
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).
PATHFINDER-52 and SUMMIT-90 are statistically powered multi-center randomized, double-blind, placebo-controlled phase 2b studies leveraging microdose and macrodose psilocybin drug assets with patient pre-screening underway. Both have been approved by Health Canada by way of a No Objection Letter (NOL).
PATHFINDER-52 evaluates multiple regular doses of APEX-52 microdose, take home orally administered synthetic psilocybin drug product in treating depression and anxiety in patients with diagnosed PTSD, recruiting 294 subjects, the world’s largest take home psilocybin clinical trial approved to date.
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.
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.
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.
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, CMO 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.
Originally published at https://www.prnewswire.com/news-releases/apex-labs-applauds-senate-subcommittees-endorsement-for-expanded-access-to-psychedelic-assisted-therapy-for-veterans-301991534.html
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