Psychedelics

LOS ANGELES- Recent research suggests that the active ingredient in psychedelic mushrooms, psilocybin, may offer significant benefits for individuals struggling with depression, pending approval from the U.S. Food and Drug Administration (FDA). With roughly one in 10 American adults experiencing depressive illness annually, the potential for psilocybin therapy to alleviate symptoms has garnered increasing attention. Psilocybin has shown promise in treating major depressive disorder, with studies suggesting that just two doses could provide relief for up to a year. Although the FDA has not yet approved psilocybin-assisted therapy, several breakthrough therapy designations have been granted for its use in treatment-resistant depression. This condition affects individuals who have not responded to ...

LOS ANGELES- Mind Medicine (MindMed) Inc., a clinical-stage biopharmaceutical company focused on developing novel treatments for brain health disorders, announced its participation in three significant investor conferences in September 2024. MindMed’s management team will engage in discussions on the evolving role of psychedelics in psychiatry and brain health treatments. The company’s schedule includes: A panel discussion at the H.C. Wainwright Global Investment Conference on September 10. A fireside chat at Baird’s Global Healthcare Conference on September 11. A second fireside chat at the Cantor Global Healthcare Conference on September 17. All events will take place in New York, and audio webcasts of the presentations will be accessible through MindMed’s Investor ...

LOS ANGELES- Awakn Life Sciences Corp. announced the screening of its first patient for the Phase 3 trial of AWKN-001, a new treatment targeting severe Alcohol Use Disorder (AUD). The trial, known as MORE-KARE, represents a significant milestone in assessing the effectiveness of AWKN-001. AWKN-001 combines intravenous ketamine, an N-methyl-D-aspartate receptor modulator, with structured psycho-social support. The treatment aims to reduce heavy drinking days and improve overall outcomes for individuals with severe AUD. The MORE-KARE study, co-funded by the UK’s Medical Research Council (MRC), the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences, will be conducted at eight NHS sites across the UK. The trial will ...

LOS ANGELES- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) announced a public offering aimed at raising $75 million through the sale of approximately 9.2 million shares at $7 each. The company is also offering around 1.4 million shares at a slightly discounted price of $6.99 to select investors. The offering is expected to close on August 12, with Leerink Partners and Evercore ISI acting as joint bookrunning managers. Proceeds from the offering will be used to support research and development for MindMed’s psychedelic treatments, particularly those in clinical trials targeting anxiety disorders. During its first-quarter earnings call in May, the company reported a cash reserve of $252.3 million, expected to sustain ...

LOS ANGELES- Mind Medicine (MindMed) Inc. announced a public offering aimed at raising $75 million through the sale of approximately 9.2 million shares at $7 each. The company is also offering around 1.4 million shares at a slightly discounted price of $6.99 to select investors. The offering is expected to close on August 12, with Leerink Partners and Evercore ISI acting as joint bookrunning managers. Proceeds from the offering will be used to support research and development for MindMed’s psychedelic treatments, particularly those in clinical trials targeting anxiety disorders. During its first-quarter earnings call in May, the company reported a cash reserve of $252.3 million, expected to sustain operations until ...

LOS ANGELES- Optimi Health, a GMP-approved and Health Canada-licensed psychedelics pharmaceutical manufacturer, has entered into a non-binding Letter of Intent (LOI) with Psyence Biomedical Ltd. . This partnership positions Optimi as the exclusive supplier of nature-derived (non-synthetic) psilocybin extract for Psyence's global drug development and commercialization efforts, particularly within the FDA-approved palliative care context. Under the terms of the LOI, Optimi will provide Chemistry, Manufacturing, and Control (CMC) support for Psyence’s regulatory submissions and any future Investigational New Drug (IND) applications. Psyence will secure exclusive rights to Optimi’s drug candidate for treatment use in palliative care. Optimi CEO Bill Ciprick highlighted the partnership’s potential to advance psilocybin-based therapies, while Psyence ...

Silo Pharma Inc. a biopharmaceutical company, has entered into a collaboration with WuXi AppTec to conduct preclinical research on a novel peptide, SPU-16, aimed at treating multiple sclerosis (MS). This partnership focuses on assessing the tissue specificity of SPU-16, which is designed to target inflamed tissues in the central nervous system, particularly within the spinal cord. The study, managed by WuXi AppTec, will utilize an experimental autoimmune encephalomyelitis (EAE) model, a standard protocol in MS research, to evaluate the peptide's effectiveness in targeting inflammation. Silo Pharma’s CEO, Eric Weisblum, expressed optimism about SPU-16’s potential to enhance current and future MS therapies while reducing drug toxicity. Silo Pharma is also advancing ...

LOS ANGELES- MindBio Therapeutics Corp. a Vancouver-based biopharmaceutical company, has announced promising durability data from its Phase 2A clinical trials testing MB22001, a proprietary microdosed LSD treatment for depression. The study, which involved self-administered, take-home microdoses, showed that patients experienced a 62.8% reduction in depressive symptoms three months after completing an 8-week course. The Phase 2A trial demonstrated a strong safety, adherence, and tolerance profile, aligning with results from earlier Phase 1 trials. The findings support MindBio’s strategy of using low-dose, non-hallucinogenic psychedelic therapies for community-based treatment, distinguishing it from the more common high-dose clinic-based therapies in the psychedelic sector. MindBio is currently the only organization conducting multiple Phase 2B ...

LOS ANGELES- A recent small randomized controlled trial has revealed that a single high dose of psilocybin induces significant and persistent changes in brain functional networks in healthy adults. The findings, published in Nature, provide new insights into the effects of psychedelics on brain activity and their therapeutic potential. The study found that psilocybin's impact on the brain's functional networks was more than three times larger than that of the control drug, methylphenidate. Joshua S. Siegel, MD, PhD, an instructor in psychiatry at Washington University School of Medicine in St. Louis, Missouri, noted that psilocybin "is erasing boundaries between brain networks." Using precision functional MRI (fMRI) mapping, the researchers tracked ...

LOS ANGELES- Numinus Wellness is at the forefront of transforming mental health care, focusing on innovative treatments, strategic mergers, and operational refinements. This article delves into the market trends, financial performance, and strategic initiatives shaping the future of Numinus Wellness and the broader mental health landscape. Financial Performance: A Mixed Bag of Results Numinus Wellness recently reported its Q3 Fiscal 2024 financial outcomes, revealing challenges and opportunities. Revenue figures dropped slightly to $4.3 million, a 1.9% decrease from the previous quarter. Similarly, gross profits fell by 9.8%, reaching $1.0 million. Despite these declines, Numinus maintains a strong cash position of $3.7 million as of May 31, 2024, demonstrating prudent fiscal ...

LOS ANGELES- Silo Pharma, Inc. a developmental stage biopharmaceutical company, has announced an exclusive global license agreement with Columbia University to develop, manufacture, and commercialize its lead drug candidate, SPC-15. This intranasal treatment targets stress-induced affective disorders and PTSD. Exclusive License for SPC-15 Development Silo Pharma has entered into an exclusive, global license agreement with Columbia University to further develop SPC-15, a novel treatment for PTSD and anxiety. This agreement allows Silo to advance its efforts in creating effective treatments for these disorders. Regulatory Progress and FDA Interaction Earlier this month, Silo submitted a pre-IND briefing package and meeting request for SPC-15 to the U.S. Food and Drug Administration (FDA). ...

LOS ANGELES- Clearmind Medicine Inc., a clinical biotech company specializing in psychedelic-derived therapeutics, has announced a significant advancement in its MEAI-based binge behavior regulator program. The company received patent approval from the Hong Kong Patent Office for its innovative use of primary amine aminoindan compounds to regulate binge behavior. The patent covers the use of these compounds, including the company's flagship molecule, 5-methoxy-2-aminoindan (MEAI). This latest addition extends Clearmind's intellectual property portfolio, which now includes 28 granted patents across 18 patent families in key jurisdictions such as the US, Europe, China, India, and Hong Kong. MEAI is designed to reduce the desire to consume alcohol while providing a mild euphoric ...

LOS ANGELES- Americans are increasingly curious about microdosing, a practice involving minimal consumption of psychedelics or cannabis over extended periods, according to a study by the University of California San Diego published in JAMA Health Forum. The study reveals a 1250% increase in Google searches about microdosing from 2015 to 2023, with over three million searches in 2023. Kevin Yang, M.D., a psychiatry resident at UC San Diego School of Medicine, led the research. Yang's study highlights how legislative changes on substance use influence public behavior and interest. The study correlates the rising curiosity about microdosing with relaxed local, federal, and state laws on recreational cannabis and therapeutic psychedelic use. ...

LOS ANGELES- Incannex Healthcare Inc. a clinical-stage pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to commence a Phase 2 clinical trial for its psilocybin pharmaceutical formulation, PSX-001, in combination with psychotherapy for patients with generalized anxiety disorder in the United States and the United Kingdom. The FDA completed its review of Incannex's Investigational New Drug (IND) application, submitted on June 26, 2024, within the designated 30-day period. The regulatory body has deemed the trial, named PsiGAD2, safe to proceed following an evaluation of the trial protocol, lead investigator, and a risk-benefit analysis of the trial and prospective drug product. The PsiGAD2 trial will enroll ...

LOS ANGELES- Arizona Governor Katie Hobbs has signed a bill into law that enables firefighters and peace officers with post-traumatic stress disorder (PTSD) to receive workers' compensation coverage for MDMA therapy, contingent upon federal legalization. While Governor Hobbs vetoed a separate proposal to legalize psilocybin service centers earlier this week, she approved legislation authorizing the Industrial Commission of Arizona to provide compensation for a one-course treatment of MDMA for public safety officials with PTSD if the drug receives approval from the Food and Drug Administration (FDA). The bill's enactment follows a recent recommendation by an FDA advisory committee against approving a new drug application for MDMA-assisted therapy, drawing criticism from ...

LOS ANGELES- Canadian psychedelics firm MindBio Therapeutics Corp. on Friday released durability results from its Phase 2A trial for its patented take-home microdose version of lysergic acid diethylamide (LSD), designed to treat depression with "sub-hallucinogenic" doses. The trial found the drug "is a safe and effective drug for treating depression with a psychedelic medicine to patients out in the community." The second trial reinforced findings from an earlier one, the company said in a press release, supporting the potential for the commercial debut of the drug for depression patients. The company's model posits that its product, formally called MB22001, in the take-home version can be a more cost-effective psychedelic treatment ...

LOS ANGELES- Arizona Governor Katie Hobbs vetoed a bill on June 18 that would have permitted the use of psilocybin in designated treatment centers. The vetoed House Bill 1570 proposed $5 million in annual funding for psilocybin therapy, overseen by the Department of Human Services, which would have regulated therapy centers and facilitators. The bill also sought to establish the Arizona Psilocybin Advisory Board to develop the program and conduct studies. Governor Hobbs explained her decision, citing the need for more evidence before supporting widespread clinical expansion. “The state’s psilocybin research advisory board established last year recently issued its annual report, with a clear message: although psilocybin may be a ...

LOS ANGELES- A recent study available through the National Library of Medicine provides new insights into the use of psilocybin for treating psychiatric disorders and its potential in psychedelic-assisted psychotherapy. This study is the first to explore reinforcement learning with psilocybin. Researchers conducted a probabilistic cue-reward task, presenting participants with emotional cues—either neutral or fearful faces—both consciously and subconsciously. The goal was to examine how psilocybin affects learning processes when interacting with emotional stimuli. The findings showed that across various dosages, psilocybin maintained learning effects and performed comparably to a placebo, suggesting that psilocybin does not impair reinforcement learning. Participants displayed higher exploratory behavior under psilocybin, indicating potential enhanced cognitive flexibility. ...

LOS ANGELES- Older individuals who have used psychedelics exhibit better cognitive functioning and fewer depressive symptoms compared to those who have not, according to new research published in Gerontology & Geriatric Medicine. However, psychedelic usage was not linked to improvements in episodic memory. Psychedelics are substances that alter perception, mood, and cognitive processes, often inducing hallucinogenic or introspective experiences. Popular psychedelics include LSD, psilocybin (found in certain mushrooms), and ecstasy (MDMA). Historically, some psychedelics have been used in cultural and religious rituals to induce spiritual experiences and enhance self-awareness. In modern times, psychedelics are considered illicit substances in most jurisdictions. However, studies in recent decades have indicated that they can ...

LOS ANGELES- A psilocybin therapy bill introduced by California Senators Brian W. Jones and Josh Becker on June 6 seeks to establish a three-year pilot program for military veterans and first responders. Senate Bill 803, known as the Heal Our Heroes Act, proposes the creation of this program in San Francisco County, Santa Cruz County, and San Diego County, pending legislative approval. The bill, an amendment to an unrelated bill, aims to facilitate psilocybin or psilocyn therapy by approved facilitators, including licensed medical and mental health professionals. Data collection would begin after the program's second year, with the goal of evaluating the treatment's effectiveness for participants suffering from conditions such ...

LOS ANGELES- Optimi Health Corp, a Health Canada licensed GMP psychedelics pharmaceutical manufacturer specializing in controlled substances such as botanical psilocybin and MDMA, has announced several significant milestones in its international psychedelic supply operations and corporate marketing strategy. Optimi has successfully completed its first international shipment of in-house manufactured MDMA active pharmaceutical ingredient (API) to the Institute for Psychedelic Research at Tel Aviv University (IPR-TLV) in Israel. This was facilitated by the necessary Export Permit from Health Canada, marking a pivotal step in Optimi’s mission to support global psychedelic research and innovation. “Completing our first international export of MDMA to Israel is an important milestone for the company,” said Bill ...

LOS ANGELES- Beckley Psytech, a private psychedelics medicine company, announced on Monday the commencement of a new research study investigating the neurophysiological effects of BPL-003, its novel synthetic intranasal formulation of 5-MeO-DMT, on the human brain. The study, funded by Beckley Psytech, is being conducted at Imperial College London. The study's initiation follows a recent update from the company regarding its ongoing Phase IIa study of BPL-003 in patients with treatment-resistant depression. Dr. Rob Conley, chief scientific and medical officer at Beckley Psytech, expressed pride in supporting the research at Imperial College London. He noted that literature suggests a link between the intensity of psychedelic experiences and positive treatment effects, ...

LOS ANGELES- Filament Health, a psychedelic drug development company, has received authorization from Health Canada and the United States Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial of its botanical psilocybin drug candidate, PEX010, for the treatment of methamphetamine use disorder (MAUD). This marks the first clinical trial to investigate the safety and efficacy of botanical psilocybin in treating MAUD. The urgent need for new interventions to address MAUD is underscored by the absence of FDA-approved pharmacotherapies and the limited effectiveness of existing options. A comprehensive approach, potentially involving psychedelic-assisted psychotherapy, is suggested to address the complexities of MAUD, including reducing stimulant overdose and relapse. Dr. ...

LOS ANGELES- Earlier today, staff from the U.S. Food and Drug Administration (FDA) expressed concerns regarding the interpretation of data from trials on the psychedelic drug MDMA for treating post-traumatic stress disorder (PTSD). These concerns emerged ahead of an upcoming meeting of the agency’s advisory panel. The comments have set the stage for in-depth discussions on the benefits and risks of this therapy by the FDA’s advisory panel, scheduled for Tuesday. This marks the first time the FDA is reviewing the therapeutic use of MDMA, a substance commonly known as ecstasy or molly. The FDA is seeking recommendations from its advisers on a capsule version of MDMA developed by Lykos ...

NEW YORK-  Numinus Wellness Inc.  announced that its research site, Cedar Clinical Research (CCR), has been chosen for Cybin's Phase 3 clinical trial of CYB003, aimed at treating Major Depressive Disorder (MDD). This selection highlights a significant step in transforming mental health care. The inclusion of CCR, located in Murray, Utah, among 15 U.S. sites for this trial underscores Numinus's commitment to advancing innovative behavioral health treatments. This collaboration aims to explore new therapies that could significantly impact patient care. Cybin's Phase 2 trial results were promising, with 75% of participants achieving remission from depression symptoms four months after dosing with CYB003. These results led the U.S. Food and Drug ...