- Data from newly acquired study could accelerate clinical development of CYBN’s CYB004 by nine months
- The pivotal study was designed with four primary objectives
- Cybin’s proprietary substance has potential to effectively treat anxiety disorders, including GAD and SAD
Cybin (NEO: CYBN) (NYSE American: CYBN) has completed the acquisition of the largest dimethyltryptamine (“DMT”) study to date, a Phase 1 N,N-DMT study that provides key data relating to the company’s proprietary CYB004 substance (https://ibn.fm/2Ab0T). Information from the study is expected to help the company accelerate by up to nine months its clinical development pathway of CYB004.
“With the closing of this transaction we are well on our way to advancing CYB004 through Phase 1 development and gathering essential safety and dosing optimization data that will inform the clinical path forward for this important molecule,” said Cybin CO Doug Drysdale. “Cybin now has multiple clinical-stage programs ongoing that we believe will contribute significantly to a greater understanding of the potential of psychedelics to provide therapeutic relief to patients who suffer with a variety of mental health issues.”
The Phase 1 EBRX-101 study, now named CYB004-E, was acquired from Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) through Cybin IRL Limited, Cybin’s wholly owned subsidiary. The study was designed with four primary objectives: to evaluate the safety of increasing doses of a single-dose, continuous DMT infusion over 90 minutes; to characterize the PK of a single-dose DMT administered continuously over 90 minutes; to characterize the PD of a single-dose DMT administered continuously over 90 minutes; and to establish the minimum DMT dose required to produce a psychedelic effect.
The adaptive, randomized, double-blind, placebo-controlled, single-ascending-dose study produced notable results. According to the study, inhaled CYB004 showed an estimated 2,000% improved bioavailability compared with orally administered DMT and a 41% improved bioavailability compared with inhaled DMT. In addition, Cybin’s CYB004 demonstrated an approximately 300% longer duration of effect when compared with IV DMT as well as a rapid onset of effect and low variability equivalent to IV DMT.
Cybin plans to evaluate the results from this study, along with other key data, to identify the next steps forward for its proprietary substance. “The most precious commodity in drug development is time, and acquiring this robust Phase 1 study already underway potentially accelerates the CYB004 development program by approximately nine months,” said Drysdale. “The PK findings from the CYB004-E study should also help to inform the clinical path forward for this innovative and proprietary molecule. This transaction also provides Cybin with access to a world-class research foundation and the privilege to work with the Entheon team, who offer a wealth of knowledge and expertise in this psychedelic class.”
CYB004 is a new chemical entity for which a patent was issued by the U.S. Patent and Trademark Office in February 2022. The proprietary substance has the potential to effectively treat anxiety disorders, including generalized anxiety disorder (“GAD”) and social anxiety disorder (“SAD”).
In its natural form, DMT is rapidly metabolized in the body and is not orally bioavailable. However, preclinical studies, including the CYB004-E study, have demonstrated that CYB004 has the potential to overcome these issues and provide increased oral and pulmonary bioavailability, faster onset with lower doses, low interpatient variability, and better dose titration, with fewer side effects and longer-acting desensitization of the serotonergic receptors.
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, 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, the Netherlands and Ireland. The company is focused on progressing psychedelics to therapeutics by engineering proprietary drug-discovery platforms, innovative drug-delivery systems, 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://ibn.fm/CYBN
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