The Week of

Praxis Precision Medicines announced that it ended a mid-stage epilepsy study for its investigational drug relutrigine ahead of schedule because of its strong performance.

Relutrigine (also known as PRAX-562) is a “small-molecule” drug designed to treat serious epileptic disorders. It works by modulating neuronal sodium channels in the brain. Many severe epilepsies are caused by hyper-excitability of nerve cells (neurons firing too frequently, causing seizures), and sodium-channel modulation is believed to be able to calm that overactivity.

Praxis will now show the data at the American Epilepsy Society meeting, then sit down with the FDA to map out the approval path. Analysts at Truist Securities are already predicting U.S. sales at around $650 million by 2037, and that may be conservative if the drug expands into broader indications. Check it out: https://ir.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-positive-results-embold‍

Clene Inc. announced completion of the FDA-recommended biomarker analyses for CNM-Au8® in people living with ALS. 

CNM-Au8 is a treatment being investigated as a potential disease-modifying therapy (not just symptom relief) for several serious neurodegenerative or neuro-metabolic disorders, including Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson's Disease (PD).

According to company reps, the results of the analysis showed statistically significant reductions in both neurofilament light (NfL) and glial fibrillary acidic protein (GFAP), and provide compelling evidence linking biomarker decline to improved survival. You can check out all the details of Clene’s analysis here: https://invest.clene.com/news-releases/news-release-details/clene-announces-statistically-significant-als-biomarker-results‍

Swiss Biotech Vandria announced its plans for a Series B financing round to advance its lead Alzheimer’s-candidate, VNA-318, into Phase 2 studies.

Unlike a lot of Alzheimer’s candidates that target amyloid or tau, Vandria is going after mitochondrial dysfunction and inflammation, which is a pathway rooted in aging biology and potentially relevant beyond just Alzheimer’s.

Proceeds from the Series B will not only go towards a Phase 2 efficacy trial, but also towards the expansion of the company’s development pipeline beyond Alzheimer’s into mitochondrial and inflammation-targeting therapeutics. Here’s more: https://jlsfund.substack.com/p/why-vandrias-new-raise-might-position

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Did you know that certain kinds of meditation may tap into some of the same “altered awareness” mechanisms as psychedelics?

Researchers from University College London were able to compare deep meditation and low- and high-dose 5-MeO-DMT in a highly experienced meditator to see how both affect consciousness and brain activity. They found that both meditation and low-dose psychedelics produced similar feelings: a loss of normal “self” sense, less inner chatter, timelessness, and calmer sensory awareness. And on the brain side, both states showed similar electrical patterns (a rise in alpha brain waves and a drop in gamma waves), suggesting they produce overlapping brain states.

That said, higher-dose 5-MeO-DMT created a different experience: vivid visual effects, intense “white light,” and a different brain‐wave signature (increased gamma), meaning the psychedelics and meditation converged in some ways, but diverged in other ways. Check it out: https://osf.io/preprints/psyarxiv/whqdp_v2