Latest news with #psychedelic
News.com.au
26-05-2025
- Business
- News.com.au
Tony's Takeaway: Tryptamine Therapeutics and the psychedelic sector
Tony Locantro has been a client advisor/investment manager in the stockbroking industry since 1998. He's focused on the small cap and emerging companies with a strong interest in identifying those in the mining, biotech and industrial sectors that offer growth potential. He also delves into the psychology of speculation and provides regular insights on a number of social media and finance related outlets. This week, Tony checks out an emerging psychedelic healthcare sector with some big developments and an Australian company in Tryptamine Therapeutics (ASX:TYP) who has recently made an eye-opening appointment of a global pharmaceuticals leader. The views, information, or opinions expressed in this video are solely those of the author and do not represent the views of Stockhead. Stockhead has not provided, endorsed or otherwise assumed responsibility for any financial product advice contained in this video. Viewers should obtain independent advice based on their own circumstances before making any financial decisions.
National Post
20-05-2025
- Health
- National Post
Cybin Applauds FDA Commissioner Dr. Martin Makary's Call to Accelerate and Prioritize Research on Psychedelic Therapeutics
Article content Article content Article content – U.S. Food and Drug Administration ('FDA') Commissioner identifies psychedelic drug development as a top agency priority in an effort to address unmet needs in mental health – Article content – Calls for FDA to be open to innovative treatments that show promise, even when they challenge traditional understanding of medicine – Article content – CYB003 granted Breakthrough Therapy Designation by the FDA for the adjunctive treatment of major depressive disorder ('MDD') – Article content TORONTO — Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (' Cybin ' or the ' Company '), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, applauds recent comments made by Dr. Martin Makary, Commissioner of the U.S. FDA relating to the importance of accelerating and prioritizing research on the clinical benefits of psychedelic therapeutics. Article content 'It is gratifying that the FDA Commissioner shares our belief in the potential therapeutic value of these innovative treatments – a long-held belief that stands at the core of Cybin's mission,' said Doug Drysdale, Chief Executive Officer of Cybin. 'We are doing the rigorous investigative clinical work to unlock the potential of this class of drugs to effectively treat a variety of disorders, including major depressive disorder and generalized anxiety disorder. We agree wholeheartedly that the time is now to address the mental health crisis, and we applaud Dr. Makary's commitment to expedite the regulatory review process for product candidates in development and to get them into the hands of providers and patients as soon as possible.' Article content 'Cybin is committed to advancing its clinical-stage programs toward potential regulatory review and approval. Our CYB003 deuterated psilocin program, which is currently in Phase 3 development, has been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of MDD which could expedite drug development timelines. We are encouraged by our ongoing positive interactions with the FDA and by the Agency's stated focus and openness to innovative treatments that show promise, even when they challenge traditional standards of care. This public endorsement that psychedelics are a 'frontier area' with compelling scientific evidence is welcome validation for the work we do every day,' concluded Drysdale. Article content Status: Dosing continues in Phase 3 APPROACH study in MDD. APPROACH is the first pivotal study in Cybin's Phase 3 PARADIGM program, which includes two 12-week randomized, placebo-controlled studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND). Article content Summary of positive Phase 2 12-Month Efficacy Data in MDD Patients Article content 100% of participants receiving two doses of 16 mg were responders. 71% of participants receiving two doses of 16 mg were in remission. Mean change from baseline in MADRS was approximately -23 points after two doses of 16 mg. Article content Upcoming Milestones: Initiate second pivotal Phase 3 study, EMBRACE, around mid-2025. Article content Upcoming Milestones: Phase 2 GAD study is expected to complete mid-2025. Article content Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions. Article content With industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds. Article content Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit or follow the team on X, LinkedIn, YouTube and Instagram. Article content Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as 'may', 'should', 'could', 'potential', 'possible', 'intend', 'estimate', 'plan', 'anticipate', 'expect', 'believe' or 'continue', or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding advancing clinical-stage programs toward potential regulatory review and approval; the potential for FDA Breakthrough Therapy Designation to accelerate drug development timelines; initiating a second pivotal Phase 3 study, EMBRACE, around mid-2025; completing a Phase 2 GAD study in mid-2025; and the Company's plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions. Article content These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three and nine months ended December 31, 2024 and the Company's annual information form for the year ended March 31, 2024, which are available under the Company's profile on SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Article content Cybin makes no medical, treatment or health benefit claims about Cybin's proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin's performance and operations. Article content Article content Article content Article content Article content Contacts Article content Article content Article content
Telegraph
19-05-2025
- Entertainment
- Telegraph
Nine Perfect Strangers, season 2, review: Nicole Kidman's psychobabble drama is one insufferable mess
Actors playing drunk always make me giggle, they so rarely get it right. But actors playing high on psychedelic drugs raises the hysteria bar to a whole other level. As performed on the returning Nine Perfect Strangers (Amazon Prime Video), it's excruciating. In its first run, Nine Perfect Strangers, based on a Liane Moriarty bestseller, introduced us to glacial psychotherapist Masha, played by Nicole Kidman with an enigmatic cool that's practically cryogenic, whose specialty is gathering a disparate group at a wellness retreat and sorting out their assorted issues. Masha is dealing with her own grief, her young daughter having died in suspicious circumstances. She uses psychedelic drugs to unlock repressed memories and, in a stretch you really have to bend to go with, she uses the drugs to connect with the dead. I did say bend. First time around Masha's guinea pigs were tolerable enough. But in its second run, the discordant nonet she's gathered at a new location, a towering sanatorium high in the Bavarian Alps, really are a piece of work. Apparently, they are all Jungian archetypes, but I'll leave that to the psychology graduates. To the non-shrink specialists, what they are is a supremely irritating bunch of indulged stereotypes with Mummy and Daddy issues. A TV puppeteer, a celebrity nun, a piano prodigy… put those in a joke and you might get a punchline, but open up their issues for drama and all you get is a feast of trippy over-acting. The set-up is very Agatha Christie, the ties which bind Masha's inmates loosely together gradually revealed over eight episodes in which her own cunning revenge plan – luring a big-shot billionaire into her spider's web of intrigue – are gradually revealed. It's that central storyline, Nicole Kidman's Masha shadow-boxing with Mark Strong 's media magnate David Shark, where Nine Perfect Strangers really sticks in the craw. Every time they cross swords and dig into their dark history – spoiler: she blames him for the death of her daughter – they somehow end up having a snog. Yeah, I can see how that would happen. Full of lazy dated references (we get characters doing Spice Girls repartee, like it's the 1990s all over again) and dreary psychobabble that's meant to sound to sound meaningful but just comes across as cringe – 'Are you afraid to go deeper?' – this really is a career low for Kidman, Strong and a supporting cast including Christine Baranski, Murray Bartlett and Annie Murphy, none of whom convince that their characters are anything more than cyphers from a psychology textbook. We've had a lot of rich folk trauma dramas lately and Nine Perfect Strangers adds very little to the party with its uninspired rehash of Philip Larkin's This Be The Verse ('They f--k you up, your mum and dad'). It looks glamorous and talks the prestige TV talk, but it's a hollow, self-indulgent emotional vacuum. As Strong's bad billionaire faced his supposed comeuppance at the closing episode's Poirot-style dénouement, his exasperated outburst took the words right out of my keyboard: 'Just f---king kill me, I can't take any more!'
Medscape
07-05-2025
- Health
- Medscape
LSD for Anxiety and Depression: Worth the Trip?
A year after the US Food and Drug Administration (FDA) opened the door to clinical use of lysergic acid diethylamide (LSD), US-based MindMed has launched phase 3 trials in the United States and Europe of MM120 (lysergide d-tartrate) for the treatment of generalized anxiety disorder (GAD) and major depressive disorder (MDD). The trials are testing the company's 100-mcg orally disintegrating tablet MM120, which received FDA Breakthrough Therapy based on results from a phase 2B trial in GAD. In that study, one dose of the drug was associated with rates of 65% for clinical response and 48% for clinical remission at 12 weeks. 'It's unprecedented in psychiatry,' investigator Daniel R. Karlin, MD, psychiatrist and chief medical officer of MindMed, said during a presentation at the European Psychiatric Association Congress (EPA) 2025. Compared with traditional psychopharmacologic therapy, the drug's effect can be measured as early as 1 day after treatment, he added. Successful phase 3 results could put MM120 in line to become the first FDA-approved psychedelic drug. What does the research show and what hurdles must the drug clear to make it to market? How Does It Work? Most experts agree that the mechanism of action of LSD remains somewhat of a mystery. What is known is that all psychedelic drugs bind to the 5-HT 2A receptor, a subtype of the serotonin receptor that plays a role in cognition, mood, perception, and other psychological processes. That binding 'seems to start a cascade of events changing how brain networks connect,' Jerrold Rosenbaum, MD, psychiatrist-in-chief emeritus and director of the Center for the Neuroscience of Psychedelics, Massachusetts General Hospital, and professor of psychiatry at Harvard Medical School, both in Boston, told Medscape Medical News . The resulting surge in synapse and neuronal growth creates neuroplasticity, 'potentially reopening critical periods for learning, and then maybe the emotional and spiritual experience,' he said. Karlin explained it as changing the brain's filter. 'If I were to tell you that I knew reliably why LSD makes people feel better the way that it does, I'd be making it up,' he said. 'People under the influence of so-called hallucinogens really aren't hallucinating. What's happening is the organizing principles that underlie their ability to perceive the world in the usual way are turned down or all the way off, and the world becomes a complicated, confusing mix of lights and colors and sounds, sounds perceived as colors, taste perceived as sound. It's the loss of organization,' he added. The result is a rearrangement of an individual's relationship with anxiety and depression, he noted. 'We have thought for a long time about psychiatric drugs in terms of symptom suppression. What we really haven't thought about is the potential for psychiatric meds, particularly in anxiety, to enhance the view of the future. It's not about feeling less overall — therefore, less anxiety — it's just feeling differently about life and about the prospects of the future,' Karlin said. Is MM120 Effective? While none of the clinical research on MM120 to date has been published in peer-reviewed journals, findings have been presented at various scientific congresses. The phase 2b dose optimization study that prompted the FDA's Breakthrough Therapy designation included 198 participants with GAD who were randomized to receive either a single administration of MM120 at a dose of 25 mcg (n = 39), 50 mcg (n = 40), 100 mcg (n = 40), or 200 mcg (n = 40) or placebo (n = 39). The primary endpoint was a change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) scores. MM120 at doses of 100 and 200 mcg demonstrated a statistically significant dose-response relationship at both 4 and 8 weeks. The estimated minimally efficacious dose to be between 56.7 and 85.1 mcg. At 12 weeks, the 100-mcg dose was associated with a 65% clinical response and a 48% clinical remission based on HAM-A scores compared with 30.8% and 20.5%, respectively, in the placebo group. Secondary outcomes showed a clinically meaningful change compared with placebo in the Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression-Severity, and Patient Global Impression-Severity scores from baseline to weeks 1, 2, 4, 8, and 12. A separate evaluation of this study also measured the ability of independent clinicians known as 'central raters' (CRs) to remain blinded to whether a participant was receiving placebo or active study drug. Findings suggested the majority of CRs remained blinded, demonstrating that study results were protected from functional unblinding. A third evaluation of the same study looked at functional disability, health-related quality of life, sleep quality, and sexual dysfunction in study participants across the five dosing arms and showed clinically meaningful improvements associated with the two higher doses as early as 1 week post-treatment and through the 12-week follow-up. Based on these results, MindMed has launched three phase 3 double-blind, randomized clinical trials to study the MM120 efficacy for GAD and MDD. The two GAD studies, Voyage and Panorama, are expected to enroll approximately 200 US participants and 250 US and European participants, respectively. Voyage will compare the 100-mcg MM120 dose with placebo on a primary endpoint of HAM-A scores at 12 weeks, followed by a 40-week extension phase with the opportunity for four open-label doses looking at safety, as well as time to and response to re-treatment. Panorama will be identical except for including a third 50 mcg 'blinding control' arm, said Karlin. The MDD trial, Emerge, is expected to enroll approximately 140 US participants and will compare the 100-mcg MM120 dose with placebo. For this trial, the primary endpoint is MADRS scores at 12 weeks, followed by a 40-week extension phase with the opportunity for four open-label doses looking at MADRS scores and the Patient Health Questionnaire for depression. 'Progress in Emerge and additional regulatory discussions will inform the design and timing of a second phase 3 study in MDD,' according to the company website. What About Safety? Safety data from early MM120 trials showed no increase in suicidal ideation, and there were minimal side effects, mostly on the day of treatment, said Karlin. The most frequent adverse events in patients in the therapeutic (100 mcg) dosing arm were illusion, reported by 60% of participants, and nausea, which affected 40%. Other side effects included euphoric mood, headache, visual hallucination, hyperhidrosis, mydriasis, altered state of consciousness, anxiety, increased blood pressure, and abnormal thinking. The frequency of these adverse events ranged from 10% to 27.5%. 'I think the reported effects are quite consistent with what a full dose LSD experience would induce. Illusions, visual hallucinations, and altered state of consciousness for someone choosing an LSD experience would likely be considered desirable, but as a therapeutic for anxiety are registered as adverse effects,' Rosenbaum said. Additionally, there are a number of known and potential harms associated with LSD use, noted Rosenbaum, who co-authored a recent review on the potential for both healing and harm. In addition to the uncommon risk for acute or long-term cardiovascular effects, some individuals have reported ongoing perceptual disturbances, including flashbacks and visual trails triggered by moving objects, he noted. 'A small percentage of people who are vulnerable, let's say, to bipolar, mania, schizophrenia, or other psychotic disorders, may be triggered by psychedelics. Others may have a terrifying and challenging experience which is traumatic itself,' he said. Hurdles to FDA Approval? Last year's FDA rejection of Lykos Therapeutics' application for midomafetamine with assisted therapy (MDMA-AT) to treat posttraumatic stress disorder was disappointing, but it doesn't necessarily mean an uphill battle for other psychoactive drugs in the pipeline, said Rosenbaum, who was a consultant for Lykos. One problem the agency noted was functional unblinding in the trials — the inability to blind participants to whether they were taking a placebo or active drug. MindMed has also made efforts to address this potential barrier with MM120 with its assessment of CRs. The Panorama trial, which has just launched, includes two LSD arms (a therapeutic dose of 100 mcg and a subtherapeutic dose of 50 mcg) plus placebo. 'The 50 mcg arm isn't of analytic interest — in the dose range finding study 50 mcg was actually the least active dose,' said Karlin. 'But it is to confound the belief of people who got 100 mcg that they got the active dose of drug.' Although Rosenbaum believes blinding in psychedelic studies is virtually impossible because 'a psychedelic experience is pretty obvious,' he and other experts in the field don't expect this to be a barrier because the FDA has overlooked this in other successful psychotropic drug applications, such as esketamine. Another problem cited in Lykos' trials was a lack of evidence to demonstrate the therapy was effective without psychotherapy assistance. 'Pairing the compound with psychotherapy was confusing things, making it harder to study and raising questions, when the FDA said, 'we don't regulate therapy,'' Rosenbaum said, referring to Lykos' MDMA compound. In early MM120 trials, patients were monitored by clinical staff through an approximately 8-hour treatment session, but there was no psychotherapy component, explained Karlin. If MindMed is successful in its application for FDA approval, one last hurdle would remain. LSD is currently classified as a schedule 1 drug under the Controlled Substances Act, making its use illegal. The US Drug Enforcement Agency would have to reschedule LSD before MM120 could be prescribed. The rescheduling process is lengthy, and the outcome is uncertain. Should Psychotherapy Play a Role? Some experts question the movement toward psychedelics as stand-alone treatment, without accompanying psychotherapy. 'Psychotherapy is as essential as pharmacological treatment in managing mental disorders, particularly in the context of psychedelic therapies,' Gabriella Gobbi, MD, PhD, professor of psychiatry at McGill University, Montreal, Quebec, Canada, told Medscape Medical News . 'The mechanisms of therapeutic action of psychedelics are not entirely dependent on neurobiology, such as receptor interactions and the activation of specific brain circuits, but also rely significantly on psychological, social, and spiritual processes,' noted Gobbi, who also is president-elect of The International College of Neuropsychopharmacology. 'For these reasons, physicians or psychotherapists involved in psychedelic-assisted psychotherapy r equire specialized training to accompany patients through this experience to enhance positive outcomes and address potential side effects.' Rosenbaum does not dispute that patients need support during their psychedelic treatment session, but in his opinion, psychotherapy is not realistic. 'You can't do therapy during a psychedelic experience. You can do hand holding, you can do monitoring, you can encourage people to stay within the treatment, and you can rescue them if they're having a challenging experience. But it's not therapy,' he said. Current FDA requirements for clinical trials call for the presence of two monitors when a patient is under the effects of a psychedelic. The lead monitor must be a licensed clinician with graduate-level professional training and clinical experience in psychotherapy. The second monitor must hold a bachelor's degree and at least 1 year of clinical experience in a licensed mental health care setting. If the FDA were to approve a psychedelic therapy, it is unclear if the agency would impose similar requirements. 'We don't think that this is moving in a direction where you don't need a monitor, but could it be one monitor? That's something we'll have to figure out,' Karlin said. 'If it can be done safely and effectively, and certainly there's precedent for that in the Swiss use of the drug. There's precedent for that in the way that [esketamine] is being used in the US and worldwide.' Rosenbaum reported holding stock or equity in Atai Life Sciences, Cerebral Inc., Entheos Labs, Psy Therapeutics, Sensorium Therapeutics, Tara Mind Inc., and Terran Biosciences; being a member of the board of directors for Cerebral Inc., Entheos Labs, Psy Therapeutics, and Sensorium Therapeutics; and being an advisor for Tara Mind Inc. and Reunion Neuroscience. Gobbi reported receiving funds from Diamond Therapeutics Inc. and being the inventor of a pending patent on the use of LSD.
