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MHRA Guidance for Regulatory Decision-Making Supports Albert Labs’ Licensing Pathway

The article MHRA Guidance for Regulatory Decision-Making Supports Albert Labs’ Licensing Pathway was originally published on Microdose.

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The article MHRA Guidance for Regulatory Decision-Making Supports Albert Labs’ Licensing Pathway was originally published on Microdose.

MHRA Guidance on the use of Real-World Data in Clinical Studies for Regulatory Decision-Making Supports Albert Labs’ Licensing Pathway

 

NEWS PROVIDED BY

Albert Labs Inc.

Jan 04, 2022, 07:00 ET

Accelerating access to psychedelic-based medicines for patients with urgent and unmet needs.

VANCOUVER, BC, Jan. 4, 2022 /CNW/ – On the 17th December 2021 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) produced guidance acknowledging and setting out the criteria for the use of Real World Data and Evidence in regulatory decision making. This guidance is consistent with Albert Labs’ strategy, one of the first psychedelic drug development companies to use a Real World Evidence (RWE) approach for regulatory approval.

Albert Labs is pursuing the RWE pathway in the licensing of their 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.

” 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 Dr. Malcolm Barratt-Johnson, the Chief Medical Officer of Albert Labs.

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.

” 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.” added Dr. Malcolm Barratt-Johnson.

Albert Labs, is following the MHRA’s guidance and taking the necessary regulatory and scientific steps required for authorization of a new treatment using an RWE approach. The trials are focused on early access to treatment. Albert Labs 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.

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs Inc.

Dr. Michael Raymont

Chief Executive Officer

About Albert Labs Inc.

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 (RWE) Albert Labs will initially look to commercialize its mycelium-based KRN-101 medicine & treatment, and in doing so deliver psychedelic-assisted psychotherapy to patients sooner. Focused on accelerating access and faster approvals, Albert Labs put patients with urgent and unmet needs first as it develops licensed medicines to treat a variety of mental health conditions. Cancer-related distress, an initial focus of Albert Labs development program is thought to affect over 1 million patients in the UK.

[1] Read the MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions here.

(https://www.gov.uk/government/publications/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions/mhra-guidance-on-the-use-of-real-world-data-in-clinical-studies-to-support-regulatory-decisions).

Listen to Albert Labs’ Chief Medical Officer, Dr. Malcolm Barratt-Johnson introduce Albert Labs and their mission here (https://youtu.be/_yMkrZgeU7k).

Watch a short “About Albert Labs” video and hear more of the investment opportunity here (https://youtu.be/otQezIvmIXI).

Cautionary Statement

This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties.  Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company’s intentions, plans, estimates, beliefs, or expectations regarding the future.  Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.

The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company’s future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements.  Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.

Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements.  The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.

SOURCE Albert Labs Inc.

For further information: Barney Neal, Chief Communications Officer at Albert Labs, Email: press@albertlabs.com, Website: https://albertlabs.com/, Tel: +44 7828 008237

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