Veteran affairs receive bipartisan support across North America, with public opinion prompting lawmakers and regulators to support innovations in veteran healthcare. The FDA designated MAPS’ MDMA-assisted therapy for post-traumatic stress disorder a breakthrough therapy in 2017 with regulatory approval expected in 2024.
In the US, it is anticipated the Department of Veterans Affairs will subsidise the treatment – with MAPS identifying a clear patient population and payer as part of its commercialisation strategy.
The company hopes to train 25,000 therapists to deliver its protocol by the end of the decade, to mitigate practitioner numbers causing a bottleneck in treatment accessibility.
Earlier this month, Apex Labs received approval for its Phase IIb trial with psilocybin in the treatment of PTSD – with patients taking the psychedelic medicine at home with minimal psychiatric intervention.
This is the first study of its kind in North America, and if successful could transform how psychedelic medicines are delivered. PSYCH spoke with the company’s CEO Tyler Powell on the announcement.
‘We are a patient-driven pharmaceutical company focused on veterans with PTSD,’ outlined Powell. ‘We put together this team with decades of healthcare and business experience, as well as a veteran population in our C-Suite, with a laser focus around PTSD.
‘What sets us apart is our clear clinical pipeline, with a Phase IIb trial now approved. The Phase IIa dose escalation trial was approved in March, after working tirelessly for years to build these protocols.
‘When Health Canada agreed to broaden the Special Access Program, or SAP, to include psilocybin and MDMA treatments, it was incredibly positive for the sector. There was a syndicate of groups that worked on Dr Masuda’s approved request for psilocybin, the first in history, including Psygen and Therapsil, and we supported it with our investigator brochure.
‘That led us down the rabbit hole of pushing to get a low-dose take-home drug approved. After months and months of hard work we were able to get the approval we needed. The trial duration is 56 days and we fully expect first patient to be dosed in under 30 days, so we are looking at a three-month timeline.
‘There is psychiatric oversight for this trial, but as a take-home drug we avoided the issue that a lot of the clinics are having here in Canada. There’s a massive shortage of therapists, let alone therapists that are trained with psilocybin.’
APEX’s low-dose psilocybin treatment, APEX-52, is consumed in a powder which is reconstituted by the patient in water, and the company is also working on a capsule. PSYCH asked Powell to expand on the company’s intellectual property strategy.
‘We have a different approach, which is quite unique,’ explained Powell. ‘A lot of companies are hyper-focused on unique formulations and patented molecules. However, we tend to believe that it is more of a generic play, and that people should be focussing more on patients.
‘If you spend tens of millions of dollars creating a new molecule, when you try to sell it to the public, no one will be able to afford it.
‘In Canada, the veteran community is suffering PTSD and depression at four to six times the rate of the civilian population. This needs to be brought to light, and working with my co-founder and Chief Strategy Officer, Arron Victory, a 14-year veteran, has really opened my eyes to what is happening behind closed doors.’
With subsidised healthcare for ex-service personnel, PSYCH was interested to know if this was baked into Apex’s commercialisation strategy as an established route-to-market.
‘Veterans have a very unique situation, as do retired RCMP officers, in the sense that they have blanket insurance coverage – which includes medicinal cannabis and ketamine-assisted psychotherapy.
‘We are looking to supply a psilocybin drug within that model, creating a PTSD drug that provides relief and also comes with built-in insurance coverage.’
Questions have been raised over the efficacy of low doses of psychedelic medicine, with researchers from Imperial College London comparing the benefits of microdosing with a placebo. PSYCH asked the Apex CEO if this data was a concern.
‘That is the challenge we are looking to address,’ recognised Powell. ‘I don’t believe there have been large enough trials to decide whether microdosing is a placebo effect or not.
‘We are aware of hundreds of veterans taking microdoses who are seeing positive feedback. The problem is that they have no awareness of dosage levels, as they are consuming unregulated products.’
Conducting large clinical trials – a regulatory requirement in the latter stages of drug development – is resource intensive. On the subject of raising capital, Powell was realistic and candid with APEX’s ambitions.
‘We are a proudly private company,’ stated the CEO. ‘We did have a go-public strategy, but we have put a pin in it for now due to market sentiment. We are looking at a 2023 public listing, to raise four to five million dollars. It is a 50 per cent raise with a 75 per cent half warrant.
‘There are some really unique opportunities, with FDA regulation the elephant in the room. We are looking at the US and are speaking with principal investors for a potential US-led study, but nothing has been solidified.
‘We want to make a splash in the US, but the UK and the Innovation Passport scheme is incredibly appealing. There are also unique markets like Brazil, which already have medical cannabis coverage for first responders. So there you have medical access and ensured coverage, which makes it an exciting proposition.
‘A big component is identifying the payer – who is going to be able to afford this treatment and how are they going to pay for it? In Canada, a six-week course of ketamine therapy can cost four to six thousand dollars. Only 1% of the population can afford that on a regular basis.
‘You could make the most beautiful drug in the world and take it to market, but if no one can afford it, it is not going to work.’
With local legislators moving quicker than medical regulators, adult-use psilocybin frameworks are emerging across North America. In other jurisdictions, prohibition has been deprioritised.
With 28 grams of psilocybin-producing mushrooms costing £100 on the unregulated market, PSYCH was interested to know if synthetic psilocybin products would be able to compete on cost.
‘It will be difficult,’ acknowledged Powell. ‘I know Optimi Health are on the border of being competitive with botanical products. We work very happily with Psygen’s API and feel that API prices will come down, as they did for CBD, as more labs come online.
‘The materials to make a kilo of synthetic psilocybin cost tens of thousands of dollars, so there is a very low barrier to entry. The problem is that the GMP lab costs tens of millions of dollars to build and you need to employ a fleet of scientists.
‘We know this problem very well as our original model involved building a GMP lab, so we are very familiar with the costs and challenges. Luckily, we pivoted away from that and stayed as an asset light company.
‘In clinical trials, psilocybin is administered in tens of milligrams or even less, so even 100 grams could supply large numbers of studies and SAP requests. I feel a lot of the laboratories created solely for psychedelic medicines are going to struggle, as there are only so many clinical trials and so many drugs they can sell.
‘Medical access is coming sooner than we think, but it still could be some years down the road. That is a long runway, with tough economic times ahead. I also think at some point Big Pharma will step in and take psychedelic medicines as a generic play, but they will wait to see who flushes out in the next two or three years. We have a built-to-acquire model, so that is right in our wheelhouse.’