HAVN Builds the Psychedelics Supply Chain by Successfully Importing Psilocybin into the U.S
HAVN Life Sciences (CSE: HAVN) (OTC: HAVLF) has announced they successfully exported naturally derived psilocybin from its facility in Jamaica into the U.S. HAVN Life’s operations in Jamaica are facilitated by strategic partnerships with Hypa Wellness and P.A Benjamin Manufacturing Company to provide cultivation and processing facilities for psilocybin-containing mushrooms for research purposes.
The importation of naturally derived psilocybin into California was made after HAVN Life’s supply partner Mycrodose Therapeutics was granted an importation license from the Drug Enforcement Administration (DEA). Mycrodose will be a distributor for HAVN’s naturally derived psilocybin in the U.S., allowing them to fulfill the various supply agreements it has in place.
A Quality Source of Psilocybin for Stakeholders
The agreement allows HAVN Life to provide naturally derived GMP psilocybin in the U.S. for authorized research purposes. This a great milestone for the industry, as HAVN navigates the regulatory framework for shipping many psychedelics still considered a Schedule 1 drugs in America – a designation reserved for drugs with high abuse potential, no official accepted medical use and lack of safety under medical supervision. HAVN Life aims to strengthen the psychedelic supply chain, by providing hundreds of research institutions, pharmaceutical companies, and non-profits across America a quality source of psilocybin for research purposes at a scalable, affordable price.
Mindset Drug Discovery: Novel 5-MeO-DMT Compounds
Mindset Pharma (CSE: MSET) (OTCQB: MSSTF) announced that in addition to its potential lead new chemical entity (NCE) candidate, MSP-4018 they have identified two additional pipeline opportunities from its Family 4 compounds, MSP-4019 and MAP-4020. In preclinical studies, these compounds demonstrated strong efficacy and an improved safety profile in comparison to 5-MeO-DMT and parent compounds.
Mindset Pharma’s Family 4 compounds are DMT inspired; synthesized and designed with macrodosing applications in mind. Family 4 medicines feature a unique serotonergic profile, shorter duration (than DMT and 5-MeO-DMT), distinct behavioural pattern.
Safety Profile: No Signs of Serotonin Syndrome
“The preclinical results of MSP-4019 and MSP-4020 demonstrated strong efficacy through a mouse head twitch assay and an improved safety profile at a range of doses up to 30 mg/kg,” stated Joseph Araujo, Chief Scientific Officer of Mindset. “Our next generation compounds showed no signs of 5-HT syndrome, a serious potential health risk associated with first-generation drugs, 5-MeO-DMT and DMT. We will continue to validate our novel compounds through translational models as we select one or more of lead drug candidates from our FAMILY 4 NCEs to advance into the clinic.”
Atai Added to the Nasdaq Biotechnology Index & Share Lock Up Extended
Atai Life Sciences (NASDAQ: ATAI) has had a very productive week, as on Monday it was announced that they will be added to the Nasdaq Biotechnology Index (NBI), effective as of the market open on Dec. 20 – the first pure psychedelics company to be added from the sector. The index comprises Nasdaq-listed biotechnology or pharmaceutical companies that also meet other eligibility criteria. This is an important milestone for psychedelics as it draws institutional attention to the sector. Although the (NBI Index and tech stocks in general) have taken a loss for the year, its has a history of long term great returns since its inception and outperformed Horizons’ and AdvisorShares’ Psychedelics ETFs respectively.
Atai also reported positive topline data from its Phase 2a study of RL-007 for Cognitive Impairment Associated with Schizophrenia (CIAS). The 32-patient, single-arm, single-blind study demonstrated a clinically meaningful pro-cognitive profile for RL-007, based on analysis of general cognition and episodic memory. Additionally, the trial showed changes in quantitative electroencephalogram (qEEG) that are consistent with previous results of a prior study of health volunteers. Together, the results support atai’s decision to progress RL-007 to a double-blind, placebo-controlled Phase 2 trial focused on cognition.
Apeiron Investment Group – the family office of Atai’s Founder and Chairman, Christian Angermayer has decided to voluntarily extend its lock-up for all of its pre-IPO common shares for an additional 2 years, subjected to limited exceptions. These shares represent approximately 17.4% of atai’s outstanding common shares.
Other of atai’s largest pre-IPO investors have signed voluntary agreements, extending their lock-up restrictions for an additional year, subject to limited exceptions. These renewed lock-up agreements represent over 30% of atai’s outstanding common shares and reveal the confidence of atai’s key shareholders in their platform and its potential to address the mental health crisis. This comes in spite of a recent downturn in the fortune of company’s stock.
Atai stock has fallen more than 30% to less than $7 per share as of the time of this writing, extending its slide into a second day. The stock is down about 46% from its June IPO price of $15.
COMPASS Pathways: Proof of Concept for Psychedelics Drugs
COMPASS Pathways (NASDAQ: CMPS) said that data from an exploratory study of its COMP360 psilocybin therapy for Treatment-Resistant Depression (TRD) shows it could be a monotherapy as well as an adjunctive treatment to a Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant.
This is big news for the psychedelics industry, providing evidence that psychedelic drug therapy can be carried out with a patient in concert with the medications they currently use.
In the study, 19 patients taking SSRI therapy with a single 25-milligram dose of COMP360 saw comparable treatment outcomes to patients in a Phase IIb trial who were withdrawn from SSRI prior to receiving COMP360.
“The results of this study challenge the widely-held belief that the use of SSRI medication together with psilocybin could interfere with psilocybin’s therapeutic effect. Our findings provide a strong signal that COMP360 therapy could be an adjunctive treatment to SSRI antidepressant as well as a monotherapy. For some patients with treatment-resistant depression, withdrawal is a difficult step even though, by definition, ‘treatment-resistant’ means that those antidepressants are not working. This is exactly why we conduct rigorous research tot help guide our clinical trial design – including addressing barriers to adoption of COMP360 therapy,” stated Guy Goodwin, COMPASS Pathways’ Chief Medical Officer.
COMPASS Pathways said it is targeting a meeting with the US Food and Drug Administration in early 2022 to finalize a phase III program that it expects to start in Q3 2022.
SAFE Banking is Still a Pipe Dream for the Cannabis Industry
The SAFE Banking Act – which is instrumental for marijuana companies to gain access to the U.S. federally-insured banking, has been removed from an omnibus defense spending bill in Congress. This could be a potential death knell for any meaningful federal reform next year. Both U.S. Cannabis Council CEO Hawkins and Colorado Representative Ed Perlmutter said that there is bipartisan support for SAFE Banking. Hawkins said he was “disappointed” that a Congress committee removed SAFE Banking from the Defense Authorization Bill.
This measure ran up against opposition from key Senate Democrats and the Drug Policy Alliance. Both groups urged lawmakers not to approve SAFE Banking before passing a comprehensive marijuana legalization bill, such as the MORE Act, which the House has approved many times, but which has ben ignored by the Senate.
Cannabis stocks continue to struggle in response to this uncertainty regarding institutional financing, as the leading stocks continue to lag the overall market. With the exception of Cresco Labs, other large cap marijuana stocks outperformed the AdvisorShares Pure US Cannabis ETF (MSOS) this week.
The Source of the “Skunk” Discovered
A new study, published in ACS Omega, has identified the source of cannabis’ “skunky” smell. According to the analysis of 13 cannabis strains, it was revealed that the pungent smell comes from a family of volatile sulfur compounds (VSCs). These compounds have not been identified in nature before but resemble those VSCs found in garlic. Although terpenes contribute to the unique smell of cannabis, they have been found to only contribute about half of the overall scent with little evidence pointing to it as a source of the “skunky” odor.
The research teams specifically looked for VSCs, as these compounds are found in skunk spray and other odoriferous plants like hops and garlic. The compounds, known as VSC3 through VSC7 all have a similar molecular structure to garlic VSCs.
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