Brenig Therapeutics, a biotechnology company developing small-molecule therapies for neurodegenerative diseases, has announced the initiation of a First-in-Human (FIH) clinical study of BT-409, its novel brain-selective NLRP3 inflammasome inhibitor. The company also provided an update on the continued clinical progress of BT-267, a CNS-optimised LRRK2 inhibitor being developed for Parkinson’s disease.

BT-409 is a small-molecule NLRP3 inhibitor licensed from Mwyngil Therapeutics and discovered using Brenig’s proprietary artificial intelligence- and machine learning-enabled drug discovery platform. The compound was specifically designed to achieve strong central nervous system penetration, high potency and pharmacokinetic properties suitable for chronic neurologic conditions.

Brenig has initiated a Phase I Single Ascending Dose (SAD) and multiple ascending dose (MAD) study of BT-409, with first dosing expected in early Q1 2026. The study will assess safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers. Following successful Phase I completion, the company plans to advance BT-409 into proof-of-concept studies in multiple sclerosis and Parkinson’s disease to evaluate the role of central inflammasome inhibition in neuroinflammation and neurodegeneration.

Commenting on the milestone, Brenig Chief Executive Officer, Megan McGill, MD, PhD, said, “The programme highlights our ability to design neuroinflammation-targeting therapies with the selectivity and pharmacology required for neurodegenerative diseases, with the goal of delivering meaningful new treatment options.”

In parallel, Brenig reported continued clinical advancement of BT-267, a highly selective LRRK2 inhibitor engineered for robust brain exposure while limiting peripheral effects. Early clinical data show a favorable pharmacokinetic profile, supporting sustained CNS exposure above predicted LRRK2 IC50 thresholds, alongside encouraging safety and tolerability to date.

The company plans to initiate a Phase Ib study and begin start-up activities for a Phase II proof-of-concept trial of BT-267 in Parkinson’s disease patients in early 2026. According to Brenig, BT-267’s high brain permeability, potency and selectivity position it as a potentially best-in-class disease-modifying therapy for Parkinson’s disease.