Welcome to the News You Might Have Missed, a weekly roundup of news items to help you catch up and stay informed.
It was a busy week with lots of news, have a look and see you next week for another update.
On Friday, Mydecine released its 2021 financial results and announced that they’ve closed the first tranche of a new capital raise, namely 3,527,337 common shares for gross proceeds of $333,333.35.
CEO Josh Bartch. “The conditional IRB approval we received is yet another positive signal that we will continue to advance our Phase 2b smoking cessation study, and we will hopefully receive full FDA IND approval in the second quarter of this year.”
Cybin Announces Initiation of Kernel Flow® Feasibility Study Measuring Psychedelic Effects on the Brain
“The commencement of the Kernel feasibility study marks a truly exciting moment, not only for Cybin and Kernel, but also for the entire field of psychedelic drug development. To this point, studies have had to rely on subjective patient reporting. By deploying the innovative Flow technology, this is the first time any company has had the ability to collect and quantify longitudinal brain activity before, during and after a psychedelic experience.
“We are specifically encouraged by this scientific advancement as it has the potential for Cybin to collect real-time quantitative data for our promising psychedelic-based therapies. These data will support the Company’s leading research position as we move our important treatment options through regulatory discussions and late-stage clinical development,” said Doug Drysdale, Chief Executive Officer of Cybin.
Entheon Biomedical Announces Expanded Psychedelics Genetic Test Panel & New Clinical Research Platform
The company announced that its expanded psychedelics genetic testing panel, developed by its wholly-owned subsidiary, is now available for sale in Canada and the United States.
“HaluGen’s testing panel and software platform are invaluable tools to enable genetic testing for psychedelics,” said Timothy Ko, Chief Executive Officer of Entheon. “We are excited to be pioneers in the field of psychedelic personalized medicine and hope that our platform can help drive valuable insights and outcomes for psychedelic therapy.”
Albert Labs’ Files U.S. Patent Application for Production of Psilocybe Mycelia and other Fungi Species
The improved quality and consistency enabled by this patent-pending process are paramount to scaling the Eu-GMP production of psilocybin Active Pharmaceutical Ingredient (API). The new process and methodology optimized key parameters necessary for the efficient cultivation that results in an increased high-quality yield of Psilocybe mycelia.
“The completion of these in vivo preclinical studies for CYB003 represents a significant milestone toward advancing this program into first-in-human clinical development and brings us one step closer to progressing CYB003 as a best-in-class treatment candidate for mental illness and addiction. We plan to focus the Phase 1/2a trial in the United States. We believe this will allow us to escalate the study through early-stage clinical development and into a potential broader Phase 2b trial, while concurrently collecting a large amount of data to support late-stage studies,” said Doug Drysdale, Chief Executive Officer of Cybin.
– Positive Phase 2b data from the COMP360 treatment resistant depression (TRD) trial; highly encouraging Phase 2a proof-of-mechanism data with RL-007 in cognitive impairment associated with schizophrenia (CIAS); clinical trial initiations of other compounds (PCN-101, GRX-917 and DMX-1002), and successful completion of 2 cohorts in the Introspect Digital Therapeutics ketamine trials
– Eight new programs added to platform since January 2021, bringing total to 13 discovery and drug development programs and four enabling or delivery technologies
– Ended 2021 as the industry’s most financially secure company, with $362 million cash on hand
– At least 14 drug development and enabling technology catalysts anticipated over the next two years, including Phase 2a proof-of-concept topline data from PCN-101 in TRD
Numinus announced that it has advanced to the next implementation phase in the clinical trial “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)” sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and organized by MAPS Public Benefit Corporation (MAPS PBC), by enrolling and dosing the first clinical trial volunteer in Canada.
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psilocybin mdma ketamine psychedelic therapeutics therapy psychotherapy depression ptsd psychedelics shares cybin entheon biomedical numinus entheon mydecine albert labs albert atai fda research