The Week of

One of our earliest portfolio companies, Psilera, published a peer-reviewed study in the journal ACS Omega describing a new synthetic chemistry platform that could significantly expand its ability to discover next-generation neuroplastogens.

The company unveiled a new method for creating and modifying psychedelic-inspired molecules based on compounds like psilocybin, DMT, and 5-MeO-DMT, which can serve as a versatile chemical building block, giving scientists a way to generate entirely new classes of therapeutic compounds that may eventually be used to treat neurodegenerative and psychiatric disorders.

The work, conducted in collaboration with researchers at the National Institute on Drug Abuse (NIDA), strengthens Psilera's broader drug discovery platform beyond its lead preclinical candidate, PSIL-006. The science is absolutely fascinating. Here’s more: https://substack.com/home/post/p-204675287.

Aurenar landed an FDA Breakthrough Device Designation for its V-Link System, a non-invasive neuromodulation device designed to reduce cerebral vasospasm, a life-threatening complication that can occur after a brain hemorrhage caused by a ruptured aneurysm.

The wireless device delivers low-energy electrical stimulation to the vagus nerve through the outer ear to help reduce inflammation and protect the brain. In an early clinical trial involving 27 patients, the therapy reduced moderate-to-severe vasospasm by more than 40%, showed no treatment-related adverse events, and was associated with a 20% reduction in 30-day hospitalization costs.

The FDA designation now gives Aurenar access to an accelerated regulatory pathway as it advances the device toward larger clinical trials and potential commercialization. Check it out: https://substack.com/home/post/p-204519616.

NeuroSense Therapeutics announced that its experimental ALS treatment, PrimeC, achieved the primary endpoint in its Phase 2b PARADIGM trial.

The study also became the first randomized, placebo-controlled trial to demonstrate a statistically significant reduction in TDP-43, the abnormal protein found in more than 97% of ALS cases and widely considered a defining hallmark of the disease.

The findings build on previously reported results showing that PrimeC slowed functional decline by roughly 33%, extended median survival by about 15 months, and maintained a favorable safety profile.

NeuroSense has already received FDA clearance to begin its pivotal Phase 3 PARAGON trial, which will further evaluate the drug as a potential disease-modifying therapy for ALS. Check it out: https://www.prnewswire.com/news-releases/neurosense-achieves-primary-endpoint-in-phase-2b-als-study-with-statistically-significant-reduction-of-tdp-43-the-defining-pathological-hallmark-of-als-302813175.html.

Did you know that psilocybin could potentially treat chronic tinnitus?

Early research suggests the compound may help "rewire" abnormal brain activity and restore balance to neural circuits involved in hearing, potentially reducing the phantom sounds many patients experience.

The science is still in its early stages, and human clinical trials are needed before any conclusions can be drawn. Still, scientists say the findings point to a promising new direction for a condition that affects more than 740 million people worldwide and still lacks effective treatment options. Here’s more: https://www.sciencedirect.com/science/article/abs/pii/S0378595526001784?via%3Dihub.