On May 23, 2018, we published revised versions of our Privacy Policy and User Agreements. Please read these updated terms and take some time to understand them. Your use of our services is subject to these revised terms.
Yes, I Agree.

NetworkNewsBreaks – Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) Moving Forward with Phase 1/2a Clinical Trial after Receiving Key FDA Approval

Company: Cybin Inc. (CYBN)
Category: News

Cybin (NEO: CYBN) (NYSE American: CYBN), a biotechnology company focused on progressing psychedelic therapeutics, has received approval from the U.S. Food and Drug Administration (“FDA”) to proceed with its phase 1/2a first-in-human clinical trial evaluating CYB003; the company has received a “may proceed” letter and investigational new drug application (“IND”) clearance from the FDA. The approval means that CYB003 will be the first  novel psilocybin analog to enter clinical development, with patient recruitment beginning immediately and pharmacokinetic and safety data readout anticipated by fourth quarter 2022. According to the announcement, Cybin’s CYB003 is a proprietary deuterated psilocybin analog being developed for possible treatment of major depressive disorder (“MDD”). A randomized, double-blind, placebo-controlled study, Cybin’s upcoming phase 1/2a trial is designed to evaluate people with moderate to severe MDD. During the trial, study participants will receive two administrations (placebo/active and active/active) with a response/remission being assessed after the first dose at week 3 and after the second dose at week 6. “We are extremely pleased to advance CYB003 into clinical development so quickly,” said Cybin CEO Doug Drysdale in the press release. “Our team has worked diligently to achieve this major regulatory milestone, and we look forward to collaborating with Clinilabs, our drug development partner, to accelerate this program. This phase 1/2a trial represents the first time that a psilocybin analog will be evaluated for the treatment of MDD and is the key next step toward our ultimate goal of providing a new and effective treatment for people suffering with mental health conditions. . . . Multiple academic studies have shown that psychedelic-based treatments, like psilocybin, may have the potential to revolutionize mental healthcare, but few companies have addressed the well-known limitations and side effects of oral psilocybin. We believe CYB003 has the potential to offer people in need with a more tolerable and potentially more effective treatment option. We look forward to advancing this important compound through clinical development.”

To view the full press release, visit https://nnw.fm/38rxP

About Cybin Inc.

Cybin is a leading ethical biotechnology company, working with a network of world-class partners and internationally recognized scientists and on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The company is focused on progressing psychedelics to therapeutics(TM) by engineering proprietary drug-discovery platforms, innovative drug-delivery systems, and novel formulation approaches and treatment regimens for mental-health disorders. For more information, visit the company’s website at www.Cybin.com.

NOTE TO INVESTORS: The latest news and updates relating to CYBN are available in the company’s newsroom at https://nnw.fm/CYBN

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

To receive SMS text alerts from NetworkNewsWire, text “STOCKS” to 888-902-4192 (U.S. Mobile Phones Only)

For more information please visit https://www.networknewswire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

NetworkNewsWire (NNW)
New York, New York
www.networknewswire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

NetworkNewsWire is part of the InvestorBrandNetwork

NetworkNewsWire Currently Accepts

Bitcoin

Bitcoin

Bitcoin Cash

Bitcoin Cash

Doge Coin

Dogecoin

Ethereum

Ethereum

Litecoin

Litecoin

USD Coin

USD Coin

Contact us: 212.418.1217