Mwyngil Therapeutics announced the initiation of a Phase 1 clinical study of BT-409, a potentially best-in-class, brain-permeable NLRP3 inhibitor being developed for multiple sclerosis (MS), Parkinson's disease (PD), and other neuroinflammatory indications.
BT-409 has been partnered to and is being clinically developed by Brenig Therapeutics, marking the first clinical-stage asset originating from Mwyngil's platform of protein–protein interaction (PPI) and cell-surface receptor modulators targeting inflammation, cardiovascular–metabolic disease (CVMD), and neurological disorders.
BT-409 is an orally administered small-molecule designed to selectively inhibit the NLRP3 inflammasome with demonstrated central nervous system (CNS) penetration. Preclinical studies support its potential to directly modulate neuroinflammation within the brain, differentiating it from peripherally restricted NLRP3 inhibitors.
The Phase 1 program will evaluate the safety, tolerability, and pharmacokinetics of BT-409 in healthy volunteers, with the objective of enabling rapid progression into patient studies in neuroinflammatory indications.
In parallel, Mwyngil is advancing a broader pipeline of NLRP3-targeted programs, including:
- Brain-permeable clinical-stage NLRP3 inhibitors targeting obesity and cardiometabolic disease.
- A systemically bioavailable NLRP inhibitor targeting chronic kidney disease (CKD)
Clinical trial initiation for both assets is planned for 2026.
Beyond NLRP3, Mwyngil is also developing a potentially best-in-class, orally bioavailable GPR75 inverse agonist for obesity and related cardiometabolic conditions, with first-in-human studies planned for 2027.
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