Bright Minds Biosciences announced the initiation of its Phase 2 Clinical Trial to evaluate BMB-101, which is a novel, highly selective 5-HT2C receptor agonist designed to treat adult patients with Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).

If you’re unfamiliar, absence seizures are classified as a type of generalized onset non-motor seizure with clinical symptoms, including unresponsiveness and staring spells. DEE represents a group of rare and severe epilepsies. DEEs commonly begin in infancy or childhood and are associated with frequent seizures, intellectual disability and significant developmental delay, regression, or plateau.

This particular study is designed as a basket clinical trial that will include patients diagnosed with either Absence Epilepsy (with or without Eyelid Myoclonia) or a DEE. The study's objectives are to assess the safety, tolerability and efficacy of BMB-101. The primary efficacy endpoints are to evaluate the change in frequency of generalized spike-wave discharges (GSWD) on a 24-hour electroencephalogram (EEG) in participants with Absence Epilepsy and the change in seizure frequency on a daily seizure diary in participants with a DEE compared to the baseline period.  Here’s more: https://finance.yahoo.com/news/bright-minds-biosciences-initiates-breakthrough-120000564.html

PharmAla Biotech Holdings announced that it was chosen to supply MDMA to a clinical trial at Johns Hopkins Medicine. The company’s primary focus is on the research, development, and manufacturing of MDXX class molecules, including MDMA.  PharmAla is also the first company authorized to provide MDMA treatments in Canada outside of clinical trials. Check it out: https://pharmala.ca/media/2024/09/pharmala-to-supply-johns-hopkins-medicine-for-clinical-trial

UCLA researchers announced that they have, for the first time, identified degeneration-associated “molecular markers” (observable changes in cells and their gene-regulating networks), that are shared by several forms of dementia that affect different regions of the brain. 

The research team carried out single-cell analysis of post mortem brain tissue, using techniques including single-nucleus sequencing of mRNA (snRNA-seq) and single-nucleus assay for transposase-accessible chromatin (snATAC-seq), which also identified markers specific to different forms of dementia. These findings represent a potential paradigm shift in the search for causes, treatments and cures.

Here’s what the study’s authors had to say …

“Alzheimer’s disease, the behavioral variant of frontotemporal dementia (FTD), and progressive supranuclear palsy (PSP) are syndromes that involve different forms of tau pathology. These three disorders collectively affect more than 28 million people worldwide and disease-altering therapeutic options are lacking, and there are few ongoing clinical trials in PSP and FTD.”

You can check out the study here: https://www.cell.com/cell/abstract/S0092-8674(24)00910-3?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0092867424009103%3Fshowall%3Dtrue

As a side note, if frontotemporal dementia sounds familiar, it’s because one of our portfolio companies, Psilera, recently announced that it received initial toxicity readouts from maximum tolerated dose (MTD) in vivo studies showing a strong safety profile with its lead candidate, PSIL-006.

If you’re a regular reader of these pages, you know that preclinical in vivo efficacy studies, conducted through the University of South Florida, have already shown PSIL-006's ability to improve the sleep, learning, and memory in humanized Tau mouse models. Bolstered by this preclinical data, Psilera is now poised to advance PSIL-006 towards first-in-human studies for FTD.

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Upcoming Event

If you’re around on Tuesday, September 17th, come join us for the launch of Psychedelic-Climate Week in New York. The event, which will feature our own Simeon Schnapper, will include the following agenda… 

Opening: “The Interconnection of Biodiversity, Indigenous Rights and Plant Medicine” with Sutton King, Urban Indigenous Collective & Julia Mande, Common Field

• “Psychedelic and Climate Policy—What to Know and How to Take Local Action in an Election Year” with Aaron Genuth, Decriminalize Nature; Madeleine MacGillivray, Seeding Sovereignty
• “Climate Action Integration—Bridging States of Being with Doing” with Amánda Argot Efthimiou, Integra
• “Psychedelics, Leadership & Regenerative Systems” with Bennet Zelner, PhD, Connected Leadership Program & Study
• “Belonging: Past the Ego to Unlock Climate Action” with Eli Walker, The Uplift Center
• “The Future is Not Fixed—Your Reality Creation Roadmap” with Douglas Rushkoff, Survival of the Richest 
• “The Perceptual Shift: Connecting with Earth Energies” with Stephanie Traeger, Intentional Paradigms
• “Herd Immunity for a Positive Climate Consciousness” with Dr. Steven Radowitz, Nushama
• “Balancing Investing & Impact with Climate & Psychedelic Capital” with Helena Wasserman, Unstoppable, Investors for Climate; Simeon Schnapper, JLS Ventures; Rose Uzunova, Psychedelic Science Funders Collaborative
• “Problems and Opportunities: AI, Climate, and Unlikely Global Solutions” with De Kai
• Closing: “Dialectic of Enlightenment - How Humanity Uses Plant-based Foods and Medicine to Create a Culture of Innovation” with Paul Miller, aka DJ Spooky 
• Q&A with Speakers & Activation: “We are the Climate Changers” with Joe and Sean Leone, dig differently

You can get tickets here: https://www.psyca.org/psychedelic-climate-week/#tickets

There will also be a number of other PSYCHEDELIC-CLIMATE WEEK events throughout the month, including …

• Music for Mushrooms, Sept. 13-19; a film on a shamanistic musician & a filmmaker’s bold experiments pairing music with psychedelics for healing in a fractured world
• Roger Wu's ChaShaMa Exhibition “Thought Experience II: Think Again,” Sept. 19-Oct.10; challenges political, social, and cultural norms to provoke reflection and action
• Climate Ring, Sept. 25-27, referred to by NYT as a “Burning Man for climate geeks,” a pop-up boxing arena for the fight of the century: for planet Earth, presented by Swissnex
• Ancient Future’s NATURE TEMPLE: Reimagining Climate Action, Sept. 26, 8am-10pm, consciousness, ancestral wisdom & psychological well-being catalyze climate action
• PAUSE: A Space to Heal and Reconnect during Climate Week, Sept. 26, 12-5pm; at DOM, join Mothers Out Front NY and planetary stewards navigating climate anxiety
• Nocturnal Medicine’s Sensuous Planet Festival, Sept. 27, 8pm-late; at CX, a consciousness-raising nightlife experience, in ritual and dance for eco-spirituality 
• Climate Cafe, "Red: A Mark Rothko Story," "Imagined Futures: Grief & Seeds," Sept. 28, 1-3pm; how to face climate pressures without being in a constant reactive state

• The New York Times Climate Forward’s Changemaker Lunch Discussion, “Can Psychedelics Help Address Climate Change?” - Sept. 25 at The Times Center
• Orchestrated Connecting and the ReAssembly24 - Sept 26 
• Transformative Impact Summit NYC, Sept. 27-29; today’s most inspiring changemakers, funders, and policy-makers share their work and co-create truly transformative change

Hope you can join us!

Did you know that sound stimulation can manipulate brain waves during REM sleep?

Using advanced technology, researchers from the University of Surrey and the UK Dementia Research Institute Centre for Care Research and Technology at Imperial College London, were able to increase the frequency of brain oscillations that slow down in dementia patients, potentially improving memory functions.

According to researchers, this non-invasive technique could pave the way for new treatments for dementia by targeting brain activity during sleep, thereby offering hope for enhancing memory and cognition with minimal disruption to patients’ lives.  Check it out: https://academic.oup.com/sleep/advance-article-abstract/doi/10.1093/sleep/zsae193/7745355