Drug developer uses RWE to research psychedelic therapies

By Jenni Spinner

- Last updated on GMT

(Eva Almqvist/iStock via Getty Images Plus)
(Eva Almqvist/iStock via Getty Images Plus)

Related tags Real world evidence Real world data Data management validation Drug development

The UK-based development and research firm hopes to accelerate patient access to psychedelic therapies for treatment of various mental health conditions.

The pharmaceutical treatment options for patients suffering from mental illnesses are broader than ever before. Still, some patients are dealing with treatment-resistant ailments, and other patients are diagnosed with conditions that have few or no treatment options at all.

Albert Labs aims to offer hope to patients looking for relief for their mental health struggles. The company is using real-world evidence studies to help patients suffering from a range of mental-health challenges gain access to MDMA, psilocybin, psilocin and other psychedelics. Outsourcing-Pharma recently spoke with Albert Labs chief medical officer Malcolm Barratt-Johnson—a 22-year industry vet who’s worked for AstraZeneca, Roche and other leading organizations—about the company’s work, and the path forward.

OSP: Could you please provide an ‘elevator presentation’ description of Albert Labs—who you are, what you do, and what sets you apart from other companies working on similar solutions?

MBJ: Albert Labs is the first psychedelic drug developer leveraging real-world evidence (RWE) Studies to accelerate patient access to psychedelic-assisted therapy in hospital settings across the UK and Europe that address niche mental health indications with urgent and high unmet needs.

Through collaborations with leading academic institutions, hospital networks, and existing reimbursement mechanisms; Albert Labs aims to accelerate effective patient-focused treatments, whilst collecting data to protect and improve its natural psilocybin-based medicines. Starting with cancer-related anxiety, depression, and existential crisis, Albert Labs will initially bring psilocybin-assisted therapy to the UK and Europe before expanding globally and therapeutically.

Albert Labs has an asset-light model that accesses existing research experts, clinical infrastructure, and patient pools to deliver its psychedelic-assisted therapies. We know the importance of treating patients who are already in need, this is where we start and from there, we will take our learnings to inform our follow-on niche indications.

OSP: Could you please provide some perspective on the use of psychedelic-assisted therapies, and how the various stakeholders (caregivers, pharma firms, researchers, patients, etc) have viewed the viability of such therapies?

MBJ: The continued success in psychedelic research is cause for celebration. Results from pinnacle studies such as the psilocybin publication released last month​ and results from MDMA Phase III trials​ even more recently provide empirical evidence in support of these new therapies.

The conditions being treated here are very complex in their own right and finding a traditional pharmaceutical model that may work, extremely difficult. Clinicians know this, and they are also aware that a holistic approach to patient treatment is needed to improve care.

We are already working with key oncology centers across the UK and the multidisciplinary teams within these centers. It is here, within the existing clinical infrastructure, that we add value through our medicines and treatment solutions. We believe our natural psilocybin medicines will better equip clinicians to treat cancer-related distress.

The viability of these treatments is clear and with our plan to provide further clinical evidence, our version of psilocybin will become, over time, a key part of the recognized treatment pathway.

OSP: What are some of the mental health conditions your firm is interested in addressing—and what are some of the challenges/problems with currently approved therapies for these conditions?

MBJ: We employ a “blue ocean” strategy that focuses on treating niche mental health indications that bigger pharma or psychedelics drug companies are not addressing. This includes cancer-related distress. There are over 3m cancer patients in the UK with we estimate, about half suffering from severe psychological distress - depression, anxiety spectrum disorder, and existential crisis.

Although this may appear to be a niche indication, 1.3m people in the UK alone is a sizable addressable market. We expect this to be approximately 5m for the United States with a similar number in mainland Europe.

Antidepressants can potentially conflict with other cancer treatments and SSRIs, currently a mainstay of treatment, has been shown to be relatively ineffective in providing relief in a little over 50% of patients suffering from anxiety and depression. Because of this, too often psychological distress in cancer can remain undertreated or compliance with therapy greatly reduced.

There have been several notable studies supporting natural psilocybin for this indication. Psilocybin has as a class of therapy, been shown to have a relatively safer side effect profile than many of the current standard treatments and a different mechanism of action. Their use we believe will offer a new and simpler treatment paradigm.

By addressing this unmet need we can begin to effectively treat these conditions faster utilizing a unique approach to licensing through our RWE strategy, collecting wider data sets that provide the necessary evidence to regulators that our product is safe, effective, and impacts positively on the quality of life and wellbeing of the individual patient.

OSP: Why is Albert Labs looking into these therapies—what problems with the approved use of these treatments help address/solve?

Malcolm Barratt-Johnson, chief medical officer, Albert Labs

MBJ: We are mainly looking at these therapies (for cancer-related anxiety) because the indication is not being addressed by other psychedelics or pharma drug developers (which also gives us a competitive, “blue ocean” advantage).

The problems our therapies solve is speed and effectiveness. We are essentially using RWE to fast track approval of our medicine that will help patients with urgent and unmet needs AND as far as effectiveness; we have seen antidepressants (SSRIs) be relatively ineffective in providing relief. These are outdated medicines, developed over 25 years ago. We have had so many technical advancements such as fMRI scanning which allows us to look at the brain in a new way, yet it’s only now, with psychedelics we’re using this newfound knowledge to develop medicines for psychological medicines such as mental health treatments.

OSP: You are reportedly the first company to use RWE to conduct research into the viability of these treatments. Why is this significant?

MBJ: In the UK and other European countries, early access to novel medicines with accelerated innovation pathways allows for new ways of assessing treatments. RWE has become a new cornerstone for early access as evidenced by its use in bringing COVID-19 vaccinations to the world in a timeframe never witnessed before. The process allows for a ‘real world’ view of innovative treatments such as Psilocybin in the clinical setting with important efficacy and safety outputs being delivered quickly.

Because patients suffering from the niche mental health indications such as cancer-related distress have an urgent and unmet need, Albert Labs needs to employ an accelerated pathway in order to provide approved treatment solutions quickly and effectively. RWE studies are sanctioned in the UK and Europe and will be the means that allow us to get our proprietary natural psilocybin medicine approved and to patients quickly.

RWE studies are a much faster and vastly less expensive way to conduct and take medicine through regulatory approval to commercialization compared to RCT trials, as evidenced in bringing COVID-19 vaccines to market.

OSP: What are the next steps?

We have assembled an enviable clinical advisory board of key international clinicians and researchers, supported with patient input to develop our protocol for our RWE trial in cancer-related anxiety. This is currently under development and will shortly be peer-reviewed and then submitted to the UK regulatory body the MHRA for scientific input and trial registration over the Summer.

By the end of 2021, we will have processes in place and commence patient selection via the hospital trial centers after which data will be gathered, reviewed and published during Q1/Q2 2022. Funding agreements will then be negotiated with the reimbursement entities so that Albert can begin to generate revenue.

Albert Labs has its Series A round underway raising C$4M at C$0.25 and previously closed its seed round of C$350K with strategic investors including The Conscious Fund (TCF) and Ambria Fund. For retail investors, Albert Labs will be going public on the Canadian Securities Exchange (CSE) in the May/June time frame.

OSP: What would you like the readers of OSP to know and understand about the use of psychedelics for mental health interventions, that we haven’t touched upon above?

MBJ: I think it is also important to share how psychedelics offer a very different treatment paradigm. The current standard of care involves muting and repression of symptoms by taking a daily medicine for a prolonged period of time.

Psychedelics and our therapy are looking to get to and solve the root cause of distress. Psychedelics act on the brain in a different way and induce a heightened state of neuroplasticity. It has been shown in this heightened state new neural pathways and connections can be formed which enable the patients to build new thought processes and avoid reverting back to the same depressive/anxious patterns which have debilitated their wellbeing for so long.

And on a final note, I think it would be valuable to understand more about what we mean about my cancer distress and anxiety, and just what impact this has on such a large group of patients.

Typically, we find the following: there is an overwhelming decrease in quality of life, social function and this is incredibly damaging greatly affecting patient's loved ones, friends and family as well as the clinicians and doctors treating these patients. In addition to this you see a reduction in medication compliance, and a general decrease in survival rates from the cancer itself. As we continue to advance care and improve survival rates surrounding oncology, patients are living longer with cancer with an avg of 6 years. During this time, we see increased suicide and a hastened desire for death. In a recent study it was shown that cancer was associated with a four-fold relative risk increase of suicide.

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