Palm Beach, FL – January 26, 2023 – FinancialNewsMedia.com News Commentary – Even during the recent global supply chain problems, certain markets have continued to show growth. The psychedelic drugs markets is one of these continually expanding markets. Psychedelic drug refers to a group of psychoactive drugs that alter perception, mood, and thought processes. All of the senses are affected by psychedelics, which change a person’s thinking, perception of time, and emotions. These include chemicals such as Lysergic acid diethylamid (LSD) and plants such as peyote. These medications are used to treat a variety of brain conditions. The various disease indications include depression and PTSD, which could be natural or synthetic. The numerous applications include treatment-resistant depression, opiate addiction, post-traumatic stress disorder, narcolepsy, and panic disorders, and are distributed through various channels such as hospital pharmacies, retail pharmacies, and online pharmacies.  A recent report from The Business Research Company projected that the global psychedelic drugs market size grew from $4.2 billion in 2022 to $4.83 billion in 2023 at a compound annual growth rate (CAGR) of 14.9%. The psychedelic drugs market size is expected to grow to $8.31 billion in 2027 at a CAGR of 14.5%. The psychedelic drug market consists of sales of psilocybin, PCP, amongst other offerings.  Active companies in the markets this week include: Lobe Sciences Ltd. (OTCQB: LOBEF) (CSE: LOBE), atai Life Sciences N.V. (NASDAQ: ATAI), COMPASS Pathways plc (NASDAQ: CMPS), Cybin Inc. (NYSE: CYBN) (NEO:CYBN), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED).

The Business Research Company report said: “The increase in the cases of mental illnesses is expected to propel the growth of the psychedelic drug market going forward. Mental illnesses refer to health conditions involving changes in emotion, thinking, or behavior. Mental illnesses include conditions such as distress and post-traumatic stress disorder. Psychedelic drugs are used to treat depression and post-traumatic stress disorder, and their regular usage decreases mental illnesses. For instance, in 2020, according to the National Alliance on Mental Illness (NAMI), a US-based mental health organization, 21% of adults in America were suffering from mental illness in 2020, which amounted to 52.9 million people. Therefore, an increase in the number of cases of mental illnesses is driving the growth of the psychedelic drug market.  The introduction of “depression spray” is the key trend gaining popularity in the psychedelic drug market. Major companies operating in the psychedelic drug market are introducing nasal spray drugs for major depressive disorders to sustain their position in the market.”

Lobe Sciences Ltd. (OTCQB: LOBEF) (CSE: LOBE) BREAKING NEWS:  Lobe Sciences, Ltd. Enters Collaborative Clinical Research Agreement with Integrative Headache Medicine of New York to Study the Effects of L-130 in the Treatment of Chronic Cluster Headache –  Lobe Sciences Ltd. (OTCQB: LOBEF) (CSE: LOBE) (“Lobe” or the “Company”), a North American Biopharmaceutical company committed to discovering and developing patient-focused psychedelic-derived medicines for neurologic and brain disease today announced that it has signed an Investigator Initiated Research Agreement with Lauren R. Natbony, MD, FAHS, Founder and Medical Director of Integrative Headache Medicine of New York, to study the tolerability and efficacy of our proprietary psilocin compound L-130, in patients suffering from Cluster Headaches (“CH”).

Mr. Philip J. Young, Chairman and Chief Executive Officer of the Company stated, “This is an exciting opportunity to evaluate L-130’s effect on the intensity, frequency, and duration of these debilitating headaches. One in every thousand people suffers from this condition, also called “Suicide Headaches,” due to the pain, frequency of attacks, and lack of effective treatments. Partnering with Dr. Natbony is a great opportunity for Lobe. As a board-certified neurologist and fellowship-trained headache specialist, she has dedicated her career to treating chronic headache and facial pain disorders, including cluster headache. We anticipate Dr. Natbony will file a physician-initiated IND, and when cleared by the US FDA, she can begin dosing CH patients with L-130 to evaluate safety, tolerability, and efficacy. CH is recognized as an Orphan Drug indication, which we intend to pursue.”

Dr. Natbony stated, “We are very excited to evaluate the impact of Lobe’s psilocin compound, L-130, in treating these devastating headaches. Data reported in the literature supports the use of psilocybin in these patients. Since L-130 is the active metabolite of psilocybin, it appears to be an efficient way of delivering non-psychedelic doses of psilocin with potentially better bioavailability and consistency. Using sub-psychedelic dosing may allow physicians a therapeutic solution to a devastating condition where treatment options are limited.”  CONTINUED… Read this full press release and more news for Lobe Sciences at:  https://www.financialnewsmedia.com/news-lobe/    

Other recent developments in the markets of note include

atai Life Sciences N.V. (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and its subsidiary GABA Therapeutics, recently announced final positive results from a Phase 1 clinical trial of GRX-917 that were previously announced as preliminary results during atai’s R&D day. The randomized, double-blind, placebo-controlled trial was designed to evaluate the safety, tolerability, and pharmacokinetic profile of single and multiple ascending doses of orally administered GRX-917.

Overall, compared to placebo, GRX-917 was well-tolerated and neither dose-related nor dose-limiting adverse events were observed. There were no serious adverse events reported nor discontinuations due to drug administration. Furthermore, in contrast to current first-line anxiety disorder treatments such as benzodiazepines, sedation was found to be comparable to placebo.

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently announced that new positive data demonstrating the potential of COMP360 psilocybin therapy in depression have been presented at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP). The results were presented from an investigator-initiated, exploratory open-label study of investigational COMP360 psilocybin therapy in type II bipolar disorder and a mechanistic analysis of the phase 2b trial of COMP360 psilocybin therapy in treatment-resistant depression (TRD).

Dr David Feifel, Principal Investigator in the COMPASS phase 2b study at Kadima Neuropsychiatry Institute, La Jolla, California, said, “The positive results published in the New England Journal of Medicine showed the efficacy of COMP360 psilocybin in treatment-resistant depression, and now these new findings are providing insights on how that antidepressant effect may be produced. This new analysis suggests that positive psychedelic experiences facilitate emotional breakthrough which may change thought patterns in people with depression.”

Cybin Inc. (NYSE American: CYBN) (NEO:CYBN), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics® recently announced key highlights from the completed feasibility study conducted by its partner HI, LLC dba Kernel (“Kernel“), evaluating Kernel’s Flow® wearable technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics. Results from this Cybin-sponsored study are intended to inform the future pathway for this program.

“The results from the feasibility study are very promising and provide further insights into the potential of this cutting-edge wearable technology to quantify neural activity and changes in brain biomarkers during the administration of psychedelics. The possibility of using this technology to develop a predictive tool to aid in identifying appropriate candidates for psychedelic-based therapy is also quite exciting, as is the convenience of a portable device, which could lend itself to more widespread use in clinical settings,” said Doug Drysdale, Chief Executive Officer of Cybin.

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED),  a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, recently  provided a corporate update and outlook for 2023.

“Following a year of continued strong execution, our progress in 2022 has set the stage for a meaningful 2023, a year in which we plan to further elucidate the potential of our MM-120 product candidate in generalized anxiety disorder (GAD) and initiate the first clinical trial for our MM-402 program,” stated Rob Barrow, Chief Executive Officer. “Our focus remains on advancing and unlocking the value of our proprietary product candidates, which we believe have the potential to deliver new, life-changing therapies to people living with brain health disorders. There are several key milestones over the next twelve months that can be used to measure our progress. This year we expect key data readouts from our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder, as well as from our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in attention-deficit/hyperactivity disorder (ADHD). Additionally, we expect to initiate the first clinical trial of MM-402 later in the year. Importantly, we believe our strong financial position provides us with the ability to fund our programs well beyond these key milestones and into the first half of 2025.”

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