Psychedelic Business Spotlight - June 3 | Psychedelic Spotlight

Cybin Submits IND Application to FDA for its Phase 1/2a First-in-Human Trial of CYB003 for the Treatment of Major Depressive Disorder

Cybin (NEO:CYBN, NYSE:CYBN) had a big week, moving their proprietary psilocybin analog —CYB003— one step closer to clinical trials. Assuming that the FDA approves their Phase 1/2a trial, CYB003 will be the first second-generation psilocybin to enter clinical trials.

CYB003 is shorter acting than regular psilocybin, and Cybin claims it will be safer with less variation in effect across individuals. Attempting to treat Major Depressive Disorder, response and remission rates will be assessed at weeks three and six. Interestingly, trial participants will be allowed to remain on their SSRI treatments.

The trial, which Cybin aims to start this year, will use EMBARK, the company’s model for psychedelic-assisted psychotherapy. This week, Cybin announced a roster of 28 faculty and advisors for the EMBARK Psychedelic Facilitator Training Program, and a paper in the Frontiers in Psychology Journal was also published, which introduces the program.

Braxia Scientific Presents Positive Preliminary Findings from Phase II Randomized, Multi-Dose Clinical Trial of Psilocybin-Assisted Therapy for Treatment Resistant Depression

Braxia Scientific Corp. (CSE: BRAX, OTC: BRAXF, FWB: 4960) announced this week that their Phase 2 psilocybin-therapy trial treating TRD had “positive preliminary results,” and that there were “Clinically meaningful improvements in depression severity observed,” though they have yet to release the exact data.

That will happen in December, “at which point the full analysis will be completed and submitted for publication.”

Braxia did confirm that there were “No serious adverse events and zero suicide attempts to date” and that a majority of adverse effects were resolved “within 24 hours of each dose” and 87% of participants requested to receive a second dose.

Nirvana Life Sciences Announces Positive Results for Addiction Relapse Prevention from their Latest Pre-Clinical Psychedelic Drug Study

Nirvana Life Sciences Inc’s (CSE: NIRV) pre-clinical study had two parts. The first evaluated the effect of “psilocybin on in-vitro rat brain cell line models,” and the second was an “in-vivo rat model on heroin self-administration and reinstatement of heroin seeking behavior following memory retrieval tests.”

In the in-vivo rat model —which means the study was on living rats— heroin-addicted rodents who could self-administer via levers they press, were given psilocybin. Interestingly, the “psilocybin decreased reinstatement of heroin seeking in female rats.” Presumably, this was not the case in male rats or Nirvana would have said so.

This study was important as it is the first “transcriptome analysis for heroin and psilocybin and their co-combination.”

PsyBio Therapeutics Initiates Commercial Biosynthetic Based Process Development for Psycho-Targeted and Psychoactive Compounds