Psychiatrist Dr. Mark Johnston as CMO and senior pharmaceutical commercialization expert Greg Rutherford as CCO accelerates APEX’s ability to bring new drugs to market.
VANCOUVER, BC, Aug. 10, 2023 /CNW/ – Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with clinically proven psilocybin treatments, announces the addition of two new executives to the c-suite, psychiatrist Dr. Mark Johnston, MD, FRCPC, as Chief Medical Officer and Greg Rutherford as Chief Commercial Officer.
Dr. Johnston, APEX CMO has been practicing psychiatry for over 20 years running a private Veteran-focused network of mental health clinics. He has been the principal investigator on over 25 central nervous system clinical trials, including trials in depression, bipolar disorder, ADHD, OCD, and Alzheimer’s dementia. Most recently he was the Medical Director of CNS Research at Centricity Clinical Trials.
“Our current treatment options for PTSD and depression are inadequate at best,” says Dr. Johnston, CMO. “Although we can have success stories with available medications, just as often we find only partial responses or intolerable side-effects. New options are desperately needed for this population, and APEX’s pipeline of psychedelic treatments has huge potential.”
Greg Rutherford, APEX CCO is a senior pharmaceutical commercialization expert with over 25 years of proven global experience optimizing multiple new drug launches, product life cycles and commercial strategy. His pharmaceutical and healthcare experience includes senior commercial roles at Johnson & Johnson, Roche, GSK and Lilly.
“With decades of experience recognizing market opportunities with emerging and novel drug assets, I am extremely excited to be part of the APEX team addressing the significant unmet clinical need within PTSD, depression and anxiety,” says Greg Rutherford, CCO. “The current standard of care treatments are sub-optimal and not meeting the needs of many patients and I see the tremendous potential for improved outcomes with psilocybin.”
Dr. Peter Tomlinson, APEX’s Co-Founder and current CMO will be shifting to the role of Chief Technical Officer to oversee the company’s clinical, regulatory and GMP manufacturing strategies as we approach the launch of multiple statistically powered phase 2b clinical trials in 2023/2024.
“The addition of a seasoned practicing psychiatrist with robust clinical trial execution experience and a global pharmaceutical commercialization expert highlights our commitment to a rigorous clinical trial strategy and optimized drug portfolio,” says Tyler Powell, APEX Co-Founder and CEO. “Exciting times ahead for the APEX team.”
About APEX Clinical Studies:
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.
APEX intends to optimize the two unique drug assets to target mild, moderate and severe disease across intended indications, addressing significant unmet clinical need.
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 Post-Traumatic Stress Disorder (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 administered in-clinic with assisted psychotherapy 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 Apex Labs Ltd.
APEX is a patient-driven pharmaceutical company focused on revolutionizing the standard of mental health care for patients with clinically proven 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 severest unmet need and strong mental healthcare infrastructure. APEX is 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: Permit approvals from Health Canada, the Drug Enforcement Administration (DEA), and US customs, Health Canada’s CTA amendments, the Company evaluating the safety and efficacy of APEX-52 (psilocybin) and APEX-90 in treating depression in Veterans with depression in post-traumatic stress disorder; statements related to APEX-52 and APEX-90, including manufacturing, dosing, and trial details; statement’s made by the Company’s CEO with respect to the Company’s efforts to enter the US market and file an IND,; statements from the Company’s CSO relating to their drug development and secondary manufacturer; statement’s made relating to Canadian Veteran patient’s taking APEX-52 in the comfort of their own home; the potential impact of epidemics, pandemics or other public health crises, including the current outbreak of the novel coronavirus known as COVID-19 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.
For further information: Max Monahan-Ellison, Vice President Corporate Affairs, [email protected]
