Cybin Inc. (CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics," has submitted an Investigational New Drug (or “IND”) application to the FDA. The aim is to begin the first phase (1/2a) of what would be the first human clinical trials to evaluate the effects of the company’s new compound called CYB003, a proprietary deuterated psilocybin analog on major depressive disorder (MDD).
CYB003 received FDA approval just last month and is now waiting to test efficacy and safety on the first group of people within the study.
Cybin CEO Doug Drysdale stated, “Based on preclinical studies, our proprietary psilocybin analog has the potential to offer numerous advantages over classic psilocybin with the potential to ultimately provide better outcomes for people suffering with MDD.”
The trial phase 1/2a is expected to be achieved by mid-2022. Carried out by Clinilabs Drug Development Corporation, a global, full-service contract research organization with expertise in central nervous system drug development, it will be a randomized, double-blind placebo-controlled study evaluating people with moderate to severe MDD. Subjects will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after a single dose) and at Week 6 (after receiving a second dose).
Using the Montgomery-Asberg Depression Rating Scale, the trial will assess the rapid onset of antidepressant effect on the day of dosing.
The study will also evaluate the benefit of more than one administration and will provide pharmacokinetic and safety data.
The trial design will allow for people to continue their treatment with selective serotonin reuptake inhibitors (or antidepressants). An optional open-label follow-up study (up to 12 weeks) will allow an assessment of the durability of treatment effects.
Photo Courtesy of Joshua Earle on Unsplash.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.
All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.
Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.
Rate collection and criteria: Click here for more information on rate collection and criteria.