08:52:07 EDT Sat 04 May 2024
Enter Symbol
or Name
USA
CA



Cybin Inc
Symbol CYBN
Shares Issued 234,683,234
Close 2023-08-17 C$ 0.44
Market Cap C$ 103,260,623
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Cybin prepares for GMP production of CYB003 capsules

2023-08-17 10:33 ET - News Release

Mr. Gabriel Fahel reports

CYBIN PREPARES FOR GMP MANUFACTURING OF CYB003 CAPSULES FOR PHASE 3 TRIAL

Cybin Inc. has initiated preparations for good manufacturing practice (GMP) production of a capsule formulation of CYB003, its proprietary deuterated psilocybin analogue in development for the potential treatment of major depressive disorder (MDD).

The company has developed a robust solid dosage capsule form of CYB003, designed to be stable, dose flexible, patient friendly and commercially scalable, to be evaluated in a potential phase 3 trial. In its current phase 2 MDD study, CYB003 dosing is under way in the final cohort. Top-line efficacy data are expected in Q3 or Q4 of 2023, after which the company intends to submit data to the U.S. Food and Drug Administration (FDA) for an end of phase 2 meeting.

"The development of a capsule formulation of CYB003 represents a meaningful advancement toward a commercially viable and more convenient dosing option that is potentially suitable for a future phase 3 trial. We are very pleased with the progression of our CYB003 program in MDD thus far. Preparations for GMP manufacturing of CYB003 capsules continue to build on our efforts to progress an improved treatment option for people with major depressive disorder," said Doug Drysdale, chief executive officer of Cybin. "Coupled with our partnership with Worldwide Clinical Trials, a global CRO [contract research organization] with deep expertise in psychedelic clinical trials, and the development of EmbarkCT, a scalable model of our psychedelic facilitation program, these efforts are a testament to our clinical execution and capabilities at each step along our development pathway."

About Cybin Inc.

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin's goal of revolutionizing mental health care is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The company is currently developing CYB003, a proprietary deuterated psilocybin analogue for the treatment of major depressive disorder, and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder, and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland.

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