Over a week ago | ||||
Cybin announced that an… Cybin announced that an abstract highlighting preclinical data for its deuterated psilocybin analog CYB003 has been selected for a poster presentation at the 'From Research to Reality' Global Summit on Psychedelic-Assisted Therapies and Medicines taking place May 27-29 , in Toronto, Canada. The poster is titled Pharmacological and Pharmacokinetic Profile of CYB003, A Novel, Orally Active Analog of Psilocybin. "It is an honor to participate in this inaugural conference devoted to psychedelic-assisted therapy and to be part of the rigorous scientific work being done in the field," said Doug Drysdale, Chief Executive Officer of Cybin. "The findings from our preclinical studies on CYB003 that will be highlighted at the Summit will show that, compared to psilocybin, CYB003 may provide therapeutic benefit across a shorter clinical visit and with improved dosing accuracy resulting in improved tolerability for patients. We look forward to the opportunity to engage with leading scientists and academics in the field with the goal of advancing these treatments and improving the lives of those living with mental illness and substance use disorders." | ||||
Psychedelics Virtual… Psychedelics Virtual Investor Conference to be held on April 27-28. Webcast Link | ||||
Psychedelics Virtual… Psychedelics Virtual Investor Conference to be held on April 27-28. Webcast Link | ||||
Psychedelics Virtual… Psychedelics Virtual Investor Conference to be held on April 27-28. Webcast Link | ||||
Cybin announced that it… Cybin announced that it has partnered with Clinilabs Drug Development Corporation , a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Company's Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog. CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder. "We are delighted to partner with the Clinilabs team as we progress this important program toward a first-in-human Phase 1/2a trial. Clinilabs brings a unique combination of scientific and operational experience and deep expertise in clinical research across a range of psychiatric, neurological and substance use disorders," said Doug Drysdale, Chief Executive Officer of Cybin. "Clinilabs is ideally suited to help us accelerate the regulatory pathway for this promising treatment candidate and ultimately, to effectively treat those suffering with MDD." In multi-species preclinical studies, CYB003 demonstrated significant advantage over classic psilocybin including, less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. Cybin recently announced the completion of its IND-enabling in vivo preclinical studies of CYB003. Data from these studies support the advancement toward an investigational new drug filing with the U.S. Food and Drug Administration for the Phase 1/2a clinical trial. Cybin intends to submit an IND to the FDA in the second quarter of 2022 and expects to initiate the Phase 1/2a trial in mid-2022. |
Over a month ago | ||||
After Cybin announced… After Cybin announced results from preclinical studies evaluating CYB004, a deuterated dimethyltryptamine, or DMT, molecule, administered by inhalation, H.C. Wainwright analyst Patrick Trucchio said inhaled CYB004 demonstrates potential to improve on DMT and argues that the preclinical data "demonstrate Cybin's continued leadership in innovation in the area of mental healthcare." He reiterates his Buy rating and $10 price target on Cybin shares. | ||||
Cybin announced positive… Cybin announced positive preclinical data from a pharmacokinetic study evaluating its proprietary deuterated dimethyltryptamine molecule, CYB004, delivered via inhalation. Specifically, inhaled CYB004 demonstrated significant advantages over both IV DMT and inhaled DMT, including longer duration of action, and improved bioavailability. The study also demonstrated that inhaled CYB004 showed a similar onset of effect and dose profile to IV DMT. These data may support the potential for inhalation as a viable and well-controlled delivery system of therapeutic psychedelics. Cybin is currently developing CYB004 for the treatment of anxiety disorders. "In many studies, DMT has shown to be a promising and effective psychedelic for the treatment of mental health issues. However, known side effects like disorientation and anxiety and its mode of administration have historically hindered its use and availability. CYB004 via inhalation may solve these challenges and finally support a clinical path forward for this important therapeutic. As part of Cybin's overall mission to create safe and effective psychedelic-based therapeutics, inhaled CYB004 is being developed to potentially overcome the limitations of IV DMT and become an important treatment option for anxiety disorders for patients and physicians," said Doug Drysdale, Chief Executive Officer of Cybin. | ||||
Cybin announced that the… Cybin announced that the World Intellectual Property Organization, or WIPO, published an international patent application covering a range of inhalation delivery methods across multiple psychedelic molecules, further strengthening its long-term intellectual property position of psychedelic-based programs. | ||||
Cybin announced that… Cybin announced that Adelia Therapeutics, a wholly-controlled subsidiary of Cybin, has achieved the milestone identified as Year 1, Q2 as contemplated by the terms of a contribution agreement dated December 4, 2020 among Cybin, Cybin Corp., Cybin US Holdings, a wholly-controlled subsidiary of Cybin, and all of the previous shareholders of Adelia. Pursuant to the terms of the transaction agreement, 22,428.3 Class B common shares in the capital of the Acquiror shall be issued to the Adelia Shareholders, in satisfaction of the $228,768.77 due to them on meeting a portion of the relevant milestones, at an effective issue price of $10.20 per Class B Share, determined in accordance with the transaction agreement and applicable securities law. The Class B Shares issued by the Acquiror to the Adelia Shareholders are exchangeable for common shares in the capital of Cybin on a 10 Cybin Shares for 1 Class B Share basis, at the option of the holder thereof, subject to customary adjustments. No Class B Shares are exchangeable prior to December 14, 2021, and not more than: 33 1/3% of the Class B Shares will be exchangeable prior to December 14; 66 2/3% of the Class B Shares will be exchangeable prior to December 14, 2023; and thereafter, 100% of the Class B shares will be exchangeable. | ||||
Cybin reported the… Cybin reported the completion of in vivo preclinical studies evaluating its deuterated psilocybin analog CYB003 for the potential treatment of major depressive disorder, or MDD. Data from in vivo preclinical studies demonstrate that CYB003 is well-tolerated following several doses in multiple species and support the advancement toward an investigational new drug, or IND, filing with the FDA for a Phase 1/2a first-in-human clinical trial in patients with MDD. The preclinical in vivo studies followed FDA protocol and were completed under Good Laboratory Practice, or GLP, guidelines. In multi-species preclinical studies, CYB003 demonstrated: a well-tolerated profile following several doses in multiple species that supports repeat dosing in humans; a similar in vitro and in vivo pharmacology profile when compared to psilocin, the active naturally occurring psychedelic agent in psilocybin; a 50% reduction in variability compared to classic psilocybin, indicating the potential for more accurate dosing; a 50% dose reduction compared to classic psilocybin, indicating the potential to maintain equivalent efficacy while reducing side effects; a 50% shorter time to onset when compared to classic psilocybin, indicating the potential for shorter duration of treatment, lower inter-subject variability, and better therapeutic control and nearly double the brain penetration when compared to classic psilocybin, indicating the potential for a less variable treatment response. The company plans to submit an IND to the FDA in the second quarter of 2022 and to initiate the Phase 1/2a clinical trial in mid-2022. |