Awakn Life Sciences announced that its Phase III clinical trial with ketamine-assisted therapy for the treatment of alcohol-use disorder would be delivered across seven NHS sites in the UK.
Furthermore, two-thirds of the study will be funded by UK government agencies, in recognition of the treatment’s potential efficacy and its socioeconomic impact. The Phase III trial is expected to cost £2.25 million, with grant funding from National Institute for Health and Care Research and the Medical Research Council totaling approx £1.5 million.
It is estimated over two million UK adults have serious alcohol problems, but only one in five receive treatment. To discuss alcohol-use disorder, addiction and Awakn’s expansion across the Atlantic, PSYCH spoke with Kevin Lorenz, US Head of Commercial Development.
‘The news that the NHS would fund two-thirds of Awakn’s Phase III study in the treatment of alcohol-use disorder is not only good news for Awakn, but good news for the industry as a whole,’ declared Lorenz.
‘Funding from a government healthcare system lends more weight to the treatment’s potential and I am really excited by that.’
In his role at Awakn, Lorenz leads the company’s commercialization in the United States, spearheading its licensing partnership business. He is responsible for signing licensing partnership agreements with 3 clinics to date, broadening Awakn’s footprint to 4 countries, and brings to the table over 20 years’ commercial biotechnology experience.
‘I have spent more than 15 years in the addiction medicine world,’ shared Lorenz. ‘They have very good systems in place to detoxify people. There are also systems in place to provide therapy, but often the therapy provided is not the therapy needed for ketamine-assisted therapy – specifically the set and setting piece, in addition to the guided dosing session and integration afterwards.
‘When somebody has an alcohol-use-disorder problem, they either take the initiative to treat it themselves, or are prompted to address it in response to consequences in their life. There are many settings where alcohol-use disorder can be treated in North America; however, there are only two that are a good fit for the solution provided by Awakn. The first is a small group of ketamine providers that need help with the therapy piece; then there is the larger group of 15,000 addiction medicine providers.
‘Speaking very generally, addiction is part of mental health, and ketamine-assisted therapy can help people with mental health problems get to the core of their issues.
‘I had knee surgery earlier this year, but before this I was managing the symptoms the best I could. I took pills to manage the pain, but I was managing symptoms that were progressively getting worse and not treating the core issue. Finally, I went for surgery, which removed the cause of the swelling, and afterwards I had no symptoms to manage.
‘I do not think it is radically different when treating mental health and addiction disorders. The standard narrative with AUD is that alcohol use is the problem. Another view on this disorder is that alcohol use is the symptom of the core problem; and the core problem is unresolved trauma of some kind.
‘This is also true with behavioral addictions, such as with gambling or pornography addiction, they are all typically symptoms of a deeper problem the patient is trying to medicate for. If the core issue is removed, often there are no longer any symptoms to manage. Awakn is treating the core issues and is doing the research to create evidence of treatment efficacy.’
In September, PSYCH interviewed psychiatrist Dr Ben Sessa, Head of Psychedelic Medicine at Awakn, who spoke about the organisation’s drug development and commercialisation activity. As Lorenz is the individual spearheading commercialisation activity in the United States, PSYCH was keen to learn more from him about the market for ketamine treatments across the Atlantic.
‘It is a very fragmented marketplace, without a central theme, and can vary by region of the country and within states,’ acknowledged Lorenz. ‘We have seen different trends in rural and semi-rural areas versus densely populated metropolitan areas.
‘There are also differences in clinics themselves. Some are infusion clinics that do not even talk about the therapy component, and others are integrating holistic centres focused on using ketamine as a catalyst in therapy.
‘When I evaluate a ketamine clinic as a potential partner for Awakn in North America, the first step is analysing what they present on their website. Most do not even mention therapy, and when you dig into the ones that do, it often evaporates. They may have a therapist as a gatekeeper to confirm diagnosis, but often the patient never speaks with them again and simply undergoes five or six infusions, which research shows is not an effective treatment model for addiction.
‘The majority are doing their part to provide a service, on the understanding that the client is already going to therapy and that they need a catalyst, in this case ketamine, to gain more traction with it.
‘With Awakn’s three, soon to be four brick-and-mortar locations, two of which are in England and the others in Norway, they use a model that in time insurance companies and government agencies will reimburse. It is the model which evidence shows gets the greatest utility from ketamine, and that is when ketamine is used in combination with therapy to address core issues.
‘In Europe, Awakn will establish and run its own clinics. In North America and the rest of the world, it will be done on a licensing partnership model. One way to think about this is that in the UK and some other European nations we own the hardware and the software. Outside of that, we just own the software and someone else owns the hardware, with Awakn loading the software onto their system.’
At the end of 2022, Colorado voted to decriminalise psychedelic medicines and create a framework for psilocybin services. The Psychedelics as Medicine Report: Fourth Edition estimated the total addressable market could generate US$205 million a year. PSYCH was eager to learn if states with legislation enabling the use of psychedelic medicine were key targets within Awakn’s commercialisation strategy.
‘We are keenly interested in having beachheads in both Colorado and Oregon,’ revealed Lorenz. ‘I’m going through the process to find partners within those states which align with Awakn’s values. We want Awakn to be established and grow within those markets, as they will become testing grounds for the adoption of psychedelic medicine.
‘We are preparing for a future where there are many psychedelic compounds approved in combination with different therapeutic approaches. I like that Oregon and Colorado have passed similar measures, but that they are not identical, as this enables us to gather different information in terms of what works and how, in terms of government oversight and from a legal standpoint. There is a lot to be gleaned from what we can learn in both of those experiments.’
Looking to the future and the federal legalisation of psychedelic healthcare, PSYCH asked Lorenz for his thoughts on the roll-out of psychedelic medicines and expected timeframes in the US, given that cannabis remains prohibited at the federal level despite 37 states hosting medical frameworks.
‘One of the messages I have been communicating is that we need to get comfortable with the possibility that there may not be a significant inflection point,’ reflected Lorenz. ‘I think there will be slow and steady progress. Nobody knows what the future will look like, but if we look at addiction medicine as a guide, there will be many different options available to patients, of varying intensity and duration.
‘Some will pay a lot of money to go abroad for extended spa-like environments, and others will use services that take place entirely in a medical office. Similar to addiction medicine, there won’t be one single approach that wins at the expense of all others, but many different doors to the same house: a safe container in which people can find, feel and metabolize their core trauma and experience not just symptom management, but healing. It will take time to get there, but we will get there. Day by day and brick by brick, the system to deliver these treatments is being built and eventually this option will be available to all.
