A Canadian Armed Forces Veteran who served as an artillery gunner in Afghanistan has received approval to undergo psilocybin treatment through Health Canada’s Special Access Program (SAP).
Vancouver’s pharmaceutical company Apex Labs announced on Wednesday that Veteran Kelsi Sheren would be receiving the company’s macrodose drug candidate APEX-90 next month with assisted psychotherapy from a physician for the treatment of PTSD and depression.
Apex Labs received approval from the government department for a Veterans’ take-home trial on its synthetic microdose psilocybin drug candidate APEX-52 in October last year prior to dosing the first patient this January. The company has strong ties to the Veteran community and its Co-Founder Arron Victory served in the Royal Canadian Regiment for 14 years, including a six-month combat mission in Afghanistan.
“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,” said Sheren. Health Canada’s SAP enables healthcare practitioners to access psychedelics like psilocybin and MDMA for the treatment of patients with severe or life-threatening conditions when other conventional treatments have failed.
She says that obtaining SAP authorization was a difficult process and that she hopes more Veterans will be able to gain access. It is currently the only means of receiving government-approved psilocybin treatment aside from clinical trials or a Section 56 exemption — which was how Canada’s first patient to receive legal psilocybin-assisted therapy, Thomas Hartle, was able to do so in 2020.
The company’s APEX-90 clinical trial is ongoing
The treatment Sheren will be receiving adheres to the company’s SUMMIT-90 clinical trial protocol, which is a Phase IIB study of APEX-90 that Apex Labs received authorization for from Health Canada this April. The trial aims to study the effects of multiple doses of the drug in 160 Canadian patients with severe depression resulting from PTSD as well as secondary indications like anxiety and chronic pain.
Following conclusion of the study this year, Apex says it aims to challenge regulatory agencies for pre-Phase III conditional approval followed by eventual commercialization of the drug in Canada, the United States, Australia and Europe.
In June, Apex Labs received permissions from Health Canada, the U.S. Drug Enforcement Administration and U.S. customs to transport synthetic psilocybin capsules over the border between its secondary American supplier — which it says will help ensure supply chain stability in the two countries.
In 2016 Sheren started the jewellery business Brass & Unity, which donates 20 per cent of its net profits to assist with rehabilitation of Veterans’ and first responders. The funds are allocated to mental health treatments, food and clothing for homeless Veterans, prosthetic limbs and various other initiatives.
She released a book about her time in Afghanistan and life afterward at the end of July as well, also called Brass & Unity.
Apex Labs has a private shareholder base consisting of over 300 investors and aims to become publicly traded on the NEO Exchange with the symbol “APEX” in the future, which it has reserved.