In an interview with PharmaShots, Dr. Malcolm Barratt-Johnson, Chief Medical Officer of Albert Labs shared his views on the psychedelic therapies, the company's business model, and your plans for scaling the psychedelics therapies.

Shots:

• Albert Labs will be the first psychedelics company to use an accelerated pathway, known as RWE studies, to swiftly provide access to patients in need. They'll also own the study data to improve and protect their psychedelic-based therapies
• The company submitted applications for psychedelics research and dealer's licenses, which will allow the company to test, possess, buy and sell MDMA, psilocybin, psilocin, DMT
• 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. Albert Labs will be going public on the Canadian Securities Exchange (CSE) in the May/June time frame

Tuba:  What are psychedelics? Can these therapies be a game-changer in mental health?

Dr. Malcolm: Psychedelics are a class of substances that induce a heightened state of consciousness characterized by a hyperconnected brain state. Psilocybin, a psychedelic compound found in mushrooms is the most commonly known psychedelic substance and in a seminal paper released on the 15th of April of this year, it was shown how this compound may be just as effective as conventional antidepressants.

As we are well aware, the world is experiencing a devastating physical health emergency, with the coronavirus. However, experts warn that without a renewed focus on our psychological well-being, the true effect of the Coronavirus will be significantly more devastating. Loneliness, uncertainty, and grief have only been intensifying an already acute mental health crisis. Antidepressant and anti-anxiety drugs have been shown to be relatively ineffective and too often leave patients untreated. These confounding factors highlight a societal need for innovation in the way we treat mental health and it is clear that psychedelics could be this breakthrough.

Tuba:  Share the unique works of Albert Labs with our readers.

Dr. Malcolm: Albert Labs is a laboratory-based, clinical research and drug development enterprise focused on improving patient access to psychedelic-assisted therapies through the safe, timely, and efficient development of medicines across Europe.

We employ a blue ocean strategy that focuses on treating niche mental health indications that big pharma or psychedelics drug companies are not addressing including cancer-related anxiety. There are over 3 million cancer patients in the UK with about half suffering from anxiety. So although this is a niche indication, 1.3 million people is a sizable addressable market. This is closer to 5 million in the US.

Because patients suffering from this indication have an urgent and unmet need, Albert Labs will use an accelerated pathway sanctioned in the UK and Europe to get its proprietary natural psilocybin medicine approved and to patients quickly.

Tuba:  Discuss your business model and your plans for scaling the psychedelics therapies.

Dr. Malcolm: Albert Labs is forming collaborations among research institutions, medical centers, and reimbursement networks in the UK and across Europe. This is an asset-light business model as it leverages the existing clinical infrastructure and patient pools through its collaborations. 

We plan to scale these collaborations to generate revenue, ensure research institutions are published, and provide patients with faster access to urgently needed mental health treatment solutions.

Additional studies on cancer-related anxiety will be carried out in other European countries to further develop and protect Albert Labs therapies while addressing other niche mental health indications.

Albert Labs essentially raises capital to fund these accelerated trials through collaborations. Albert Labs will own the study data to improve and protect its psychedelic-based therapies in its laboratories to create a valuable IP strategy. 

Albert Labs has submitted applications for psychedelic research and a dealer's license which will allow the Company to test, possess, buy and sell MDMA, psilocybin, psilocin, DMT, and mescaline in its lab in Burnaby, BC Canada. These Health Canada licenses will also allow the company to import/export, test, and conduct R&D on these controlled substances.

Tuba:  How is Albert Labs different from other companies dealing with psychedelics?

Dr. Malcolm: Albert Labs will be the first psychedelics company to use an accelerated pathway, known as Real-World Evidence (RWE) studies, to gain approval and reimbursement for its proprietary therapy to treat patients in urgent need. RWE studies are much faster and cheaper to conduct and commercialize approved medicine compared to RCT trials and have been used recently to bring COVID-19 vaccines to market at a rapid pace. It is clear there is now a case to use this more widely and we believe Psilocybin medicines are a perfect use case due to the inarguable safety of these compounds, proven through millennia of use and most recently through RCTs.

Tuba:  Are you open to investors to receive funding for your innovative company? How can interested parties contact you?

Dr. Malcolm: 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. Venture capital funds including The Conscious Fund (TCF) and Ambria Fund have both invested in the Seed and the concurrent Series A. Accredited investors and funds can visit our site to learn more about investing in Albert Labs and to contact us directly https://albertlabs.com

For retail investors, Albert Labs will be going public on the Canadian Securities Exchange (CSE) in the May/June time frame.

Tuba:  Do you feel competition in this space? If yes, who are your potential threats?

Dr. Malcolm: Albert Labs' blue ocean strategy and asset-light model separates us from the influx of psychedelics companies that are attempting to develop a novel / synthetic version of a naturally occurring psychedelic compound or a network of clinics to treat patients and collect data. Both of these endeavors are capital and time-intensive. 

Albert is agile and will produce results and revenue quickly so that it can continue growing its brand and patient access across the UK and Europe.

In terms of competition, other companies are not focusing on the same indications in the same jurisdictions. As explained, these companies are carrying out timely and costly endeavors to recreate novel versions of these well-established medicines. Our strategy is unique, revolving around Real-World Evidence we want to treat patients faster. With the increasing awareness and adoption of RWE studies, we believe we can collect wider data sets that lays out safety, efficacy, and cost-effectiveness evidence to support the licensing of our medicines in the UK.

This doesn't come at the detriment of protection. We have a clear IP strategy that will protect us from the competition and will protect our addressable market. In addition to tangible and legal IP protection, by getting out there and treating patients sooner we will benefit from a strong first-mover advantage which will be highly regarded with patients and clinicians and enable our company to quickly expand. We remain focused and have clear values on getting these breakthrough therapies to patients who are in need. Patients who currently go untreated.

Tuba:  How is your collaboration in the UK and EU helping you to scale up the therapies?

Dr. Malcolm: Through a collaboration it makes certain that all the key stakeholders are aligned to make Psychedelic-Assisted therapy a successful treatment solution. In simple terms researchers can author highly regarded medical publications, hospital centers, and their in-house multidisciplinary teams can see patients treated, and finally, the payers reimburse fairly for life-changing treatment and for increased quality of life of these patients. By ensuring an effective working collaboration Albert Labs can stimulate faster patient acquisition and scale to other EU jurisdictions which also highly regard Real World Evidence and have similar reimbursement networks to the ones in the UK. 

Tuba:  Put some light on your Real-World Evidence studies. Also, discuss its significance.

Dr. Malcolm: Real-World Evidence a clinical pathway that enables Albert Labs to collect clinically relevant and significant data to support drug development and licensing applications whilst in turn treating patients in the hospital setting who are in need. As previously mentioned, too often patients go untreated for their psychological distress, and current treatment options are ineffective or simply not provided to oncology patients. Through this differentiated pathway, we can not only further the development of our medicines but also treat patients. This is extremely significant, it's a well-understood advantage over Randomised Controlled Trials. 

The breadth of the data that can be collected is also superior and that enables us to answer wider questions, such as which patients will be most effective for this treatment? How does it compare with other treatments ? How cost-effective is it ? How will it fit into the current healthcare system? what happens in actual clinical practice and use that to inform treatment and reimbursement decisions. 

Tuba:  Share some exclusive information about the company and its plans in the near future with our readers.

Dr. Malcolm: Our plans are to redirect the current course of mental health treatments across the globe towards ethical and efficacious pathways that will see a real benefit to patients, improving the lives of those who are currently undertreated and suffering. In terms of the near future, we will commence the first stages of our clinical trials towards the end of 2021, adopting the Real-World Evidence approach that will allow for accelerated patient access. 

We are the first company to use a Real World Evidence strategy. We believe this is a suitable, credible, and advanced way to conduct clinical research into the novel therapy model surrounding psychedelics. Real-World Evidence is quickly becoming a credible pathway that has seen support by the MHRA & NICE, and this is a unique strategy in the sector.

Source: Investor's Business Daily

About Dr. Malcolm Barratt-Johnson:

Dr. Malcolm Barratt-Johnson is the Chief Medical Officer of Albert Labs. He has 22years of experience in the pharmaceutical industry specializing in Medical Affairs, Product Development, and Regulatory Strategy.

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