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Cybin Corp’s Clinical Trials In Jamaica Are Setting The Company Up For A Quicker Route To Market Than Their Peers

Oct 14, 2020 • 7:42 AM EDT
5 MIN READ  •  By Michael Berger
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As it relates to clinical trials, Cybin is planning and designing clinical trials on major depressive disorder (MDD) and addiction in Jamaica, West Indies. The company is also conducting bioavailability studies on proprietary delivery mechanisms, and we are favorable on how this differentiates Cybin from other psychedelic therapy companies.

Cybin is in the process of conducting a Phase 2a and 2b study on MDD in Jamaica and is executing on a bridging strategy to leverage data for other jurisdictions such as North America. The company has partnered on the study with the University of the West Indies through the Caribbean Institute for Health Research. We consider this relationship to be an essential aspect of the story.

Cybin’s goal is to become the first life sciences company to bring a psilocybin drug to market for MDD. We are favorable on its ability to accomplish this. The company plans to commence the study before the end of the year, which will act as the precursor to a global drug commercialization strategy.

The clinical trial will be conducted through the University of the West Indies and will abide by ICH and GCP guidelines. This study will allow Cybin to use the study’s data as a bridging strategy to enter additional markets. From an expansion standpoint, the company is targeting the U.S., Canada, and Europe.

Within twelve months, Cybin expects to submit a marketing authorization application in Jamaica. Doing so will potentially allow the business to have the treatment approved in 2.5 years – a significantly shorter timeframe than the typical five to six years generally expected of this process. We will monitor how the management team can execute on this.

The Phase 2a study will involve 50 subjects who have been diagnosed with MDD. Of the participants, ten will take four oral film doses per arm against an oral 25mg capsule. The patients will continue to be monitored for four months after the study for safety and efficacy purposes.

In the Phase 2b study, an additional 120 patients will be enrolled in a safety and efficacy trial that starts immediately after the Phase 2a study. The study will follow the same regulatory, clinical trial to save approximately four to five months of development time. We are favorable on how the management team has structured the trial. The Phase 2b trial will study 120 patients who will dose with psilocybin oral film. We will monitor this aspect of the story.

One of the most important clinical trial outcomes is related to how the study performed with previously determined primary and secondary objectives. With the Phase 2a trial, the primary aim is to select the bioequivalence (BE) dose of psilocybin that is administrable with an oral film in subjects with MDD. With the Phase 2b trial, the primary objective is to evaluate clinical efficacy by MADRS (Montgomery–Åsberg Depression Rating Scale) score change post-dosing with oral psilocybin film in comparison to placebo film.

Evaluating the safety and tolerability of psilocybin is the secondary objective for both the Phase 2a and 2b studies. We are favorable on the human capital that is associated with the studies. We believe that Cybin has executives with the expertise needed to bring a new drug to market.

By the fourth quarter of 2020, Cybin expects to start the clinical trial on oral film in Jamaica. If the company proves that the product can treat MDD, we expect to see a massive increase in interest in the opportunity. If you look at companies’ performances conducting clinical trials, the market tends to reward businesses for positive data. We are favorable on the potential that this offers Cybin.

Dr. Lorenzo Gordon is the Director of Research at Cybin. We expect him to play a crucial role in the operations in Jamaica. Currently, he is the Vice Dean and Medical Director of the Caribbean School of Medical Sciences Jamaica (CSMSJ). Dr. Gordon has more than 50 peer-reviewed publications. We are favorable on the experience that he adds to the team.

Cybin represents a differentiated play on the psychedelic therapy market that has significant potential catalysts for growth. When compared to other operators in the space, we believe that Cybin is a more advanced opportunity. We are favorable on the strength of the management and clinical research and advisory team.

If you are interested in learning more about Cybin and how it is positioned to capitalize on the psychedelic therapy market, please send an email to support@mushroomstocks.com to be added to our distribution list.

 

(1) Subject to receipt of all necessary regulatory approvals in Jamaica from all applicable governmental authorities, including, as applicable, the academic and scientific organizations that are working with Cybin. Third parties will facilitate the trials in Canada.

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Pursuant to an agreement between StoneBridge Partners LLC and Cybin Corp. we have been hired for a period of 180 days beginning July 1, 2020 and ending January 1, 2021 to publicly disseminate information about (Cybin Corp.) including on the Website and other media including Facebook and Twitter. We are being paid $7,500 per month (Cybin Corp.) for or were paid “0” shares of restricted common shares. We own zero shares of (Cybin Corp.), which we purchased in the open market. We plan to sell the “ZERO” shares of (Cybin Corp.) that we hold during the time the Website and/or Facebook and Twitter Information recommends that investors or visitors to the website purchase without further notice to you. We may buy or sell additional shares of (Cybin Corp.) in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information.

 

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Authored By

Michael Berger

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