Albert Labs Inc said that the recent guidance provided by the UK’s Medicines and Healthcare product Regulatory Agency (MHRA) supports the company’s strategy to use the Real World Evidence approach for regulatory approval.
On December 17, MHRA produced guidance acknowledging and setting out criteria for the use of Real World Data and Evidence in regulatory decision making.
The guidance emphasizes that a study or studies considered under this guidance need to be of the same standard as would be expected from a traditional Randomized Control Trial (RCT). The guidance further states that well-designed and conducted prospective RCTs provide a high level of evidence irrespective of the categorization of the data source.
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"We embrace this regulatory guidance particularly in the investigation of psilocybin-assisted psychotherapy. Albert Labs consider that carefully designed pragmatic trials that implement a progressive use of Real World Evidence, will greatly advance the understanding of the safety, effectiveness, impact, and optimal clinical use of this new therapy," said Malcolm Barratt-Johnson, CEO of Albert Labs in a statement.
Albert Labs said that it is pursuing the RWE (ETR:RWE) pathway in the licensing of its natural psilocybin medicine, which has been endorsed by leading hospital centers in the UK. This expedited pathway offered by the UK regulatory system will accelerate access to treatment, benefiting patients, not only in the UK but the rest of Europe, Canada, and the US.
Barratt-Johnson added: "Our approach, in the investigation of psilocybin-assisted therapy, has been designed to reduce risk, improve outcomes, and importantly to speed up access to those patients who will benefit from this therapy. We believe Real World Evidence will play a vital role in helping safeguard the development of this promising mental health treatment."
Albert Labs said that it is following the MHRA's guidance and taking the necessary regulatory and scientific steps required for authorization of a new treatment using an RWE (ETR:RWE) approach. The trials are focused on early access to treatment.
The Vancouver, British Columbia-based company expects to treat patients suffering from cancer-related distress in the first half of 2022 with this focused approach and accelerated product development and licensing pathway.
A laboratory-based, clinical research and drug development enterprise, Albert Labs and its team are experts at the production and extraction of natural compounds and creating licensed medicines. Through a succinct clinical pathway, focusing on Real World Evidence, Albert Labs will initially look to commercialize its mycelium-based KRN-101 medicine and treatment, and in doing so deliver psychedelic-assisted psychotherapy to patients sooner.
Contact Ritika at ritika@proactiveinvestors.com