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Clinical-stage psychedelics biotech Cybin (NYSE:CYBN) has completed enrollment in its Phase 2 study of novel deuterated psilocybin analog CYB003 for the potential treatment of Major Depressive Disorder (MDD.)
All participants in the sixth and final cohort have reportedly received at least one dose (placebo or 16mg of CYB003) with several second doses already administered; no serious adverse events were observed.
In the other five participant cohorts, CYB003 has also so far shown a favorable safety and tolerability profile at all doses (1mg, 3mg, 8mg, 10mg and 12mg.)
Dosing of this last cohort would round up in early Q4 this year, shortly followed by topline efficacy results which would be submitted to the FDA and inform the company’s next “pivotal” studies.
Cybin aims to scale its clinical program around CYB003, which is protected by a U.S. patent until 2041, to a multinational Phase 3 study in early 2024.
The move would further include a streamlined EMBARK facilitator training program and upcoming GMP-compliant capsule production together with a global partner.
Interestingly, the Cybin team is anticipating a potential FDA “Breakthrough Therapy” designation, subject to the agency’s approval, in 2023’s last quarter.
CEO Doug Drysdale says the enrollment completion in the Phase 2 CYB003 study is “a significant milestone” for Cybin, bringing the company “closer than ever” to understanding the potential antidepressant effects and clinical advantages of the novel psychedelic compound.
The Small Pharma acquisition (OTC:DMTTF) - expected to take place within the last quarter of 2023- would help form “the most robust IP portfolio in the sector” and “enhance the combined company’s capabilities to bring these novel therapeutics through clinical development and to people in need,” Drysdale says.
The ongoing Phase 1/2 trial evaluates CYB003 simultaneously in participants with moderate to severe MDD and in healthy volunteers as follows:
In all participants, the study evaluates safety, tolerability, pharmacokinetics and pharmacodynamics (PK/PD) and psychedelic effect of ascending oral doses of CYB003.
In participants with MDD, the trial assesses rapid onset of antidepressant effect on dosing day (with MADRS,) and the incremental benefit of a second dose administered at Week 3. An optional period of assessment will help determine the durability of treatment effect out to 12 weeks.
Healthy volunteers receive two administrations (placebo/active and active/active) one week apart, and measures of psychedelic effect are assessed after each dose.
Participants with MDD receive two administrations (placebo/active and active/active) three weeks apart and response/remission are assessed three weeks after each dose. Those participants currently on antidepressants can remain on their medication.
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Photo: Benzinga edit with photo by Bacsica, aiyoshi597, Gisele Yashar and metamorworks on Shutterstock.
