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

PsyBio Therapeutics Corp. (TSXV: PSYB, OTCQB: PSYBF), a company developing novel psychoactive medicinal candidates for a range of mental health challenges, this week initiated the “formal process development for commercially scalable, patent pending manufacturing technology expected to enable Good Manufacturing Practice (“GMP”) production.”

PsyBio says they retain “the global, exclusive, and perpetual right to license a platform technology enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria and has demonstrated the ability to manufacture one of its first promising therapeutic candidates at commercial scale.”

Clearmind Medicine and SciSparc Collaboration Yields Another Patent Application for Cocaine Addiction Treatment

This week, Clearmind Medicine Inc. (CSE: CMND, OTC Pink: CMNDF, FSE: CWY0), in collaboration with SciSparc Ltd. (NASDAQ: SPRC) —a clinical-stage pharmaceutical company— filed a provisional patent application related to cocaine addiction.

The patent application “refers to the proprietary combination of Clearmind’s MEAI, a novel proprietary psychedelic treatment for addiction, with SciSparc’s CannAmide™.” Together, the two companies will pursue a pre-clinical trial “to examine the effect of the combination treatment as an anti-reward agent for treating cocaine addiction.”

While too early to make any claims about the effectiveness of this combination, treating cocaine addiction is important as at least 1.3 million Americans are addicted to the substance.

In other patent news, Clearmind was granted patent approval in India for MEAI, this time to be used as an alcohol substitute.

Ketamine Wellness Centers (KWC) Launches SPRAVATO® Nasal Spray Therapy in Minneapolis, Salt Lake City and Dallas

Delic Holdings Corp’s (CSE: DELC, OTCQB: DELCF, FRA: 6X0) subsidiary, Ketamine Wellness Centers, has “increased the total number of clinics offering the FDA-approved esketamine nasal spray to six.” Spravato will be used in these clinics to treat Treatment-Resistant Depression or depressive symptoms associated with Major Depressive Disorder.

Starting June 1st, Ketamine Wellness Centers in Minneapolis, Salt Lake City and Dallas will join the Houston, Las Vegas and Seattle locations in offering SPRAVATO to their patient base.

Optimi Health Enters Into Psilocybin Supply Agreement With Filament Health

Optimi Health Corp. (CSE: OPTI, OTCQX: OPTHF, FRA: 8BN) this week announced that they have entered into a one-year supply agreement with Filament Health (OTCQB:FLHLF, NEO:FH, FSE:7QS).

Under the agreement, Optimi will supply Filament with “psilocybin mushrooms cultivated in Optimi’s recently inaugurated 20,000 square foot EU-GMP Princeton, British Columbia facility in the form of whole, dried mushroom fruiting bodies for potential drug development, testing, and analysis by Filament’s research team.”

Novamind Reports Fiscal Q3 2022 Financial Results and Operating Highlights

Novamind Inc. (CSE: NM, OTCQB: NVMDF, FSE: HN2) a company in the process of being acquired by Numiness Wellness (TSX: NUMI, OTCQX: NUMIF), announced a “Record high quarterly revenue of $3,227,352,” which is up 32% over the previous quarter.

Despite this, the company still had a net loss of $2,434,154.

In the near future, Novamind clinics will be the home to many clinical trials, including a Phase 2b trial investigating LSD for Generalized Anxiety Disorder in adults, sponsored by MindMed, and a Phase 2 clinical trial investigating psilocybin for Major Depressive Disorder, sponsored by the Usona Institute.

Once the acquisition by Numinus is complete, the new company will have 13 wellness clinics, four research sites and one bioanalytical laboratory.


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