Mwyngil Therapeutics Initiates Phase 1 Study of BT-409 for Neuroinflammatory Diseases

Mwyngil Therapeutics has announced the initiation of a Phase 1 clinical study of BT-409. BT-409 is a potentially best-in-class, brain-permeable NLRP3 inhibitor being developed for multiple sclerosis (MS), Parkinson’s disease (PD), and other neuroinflammatory indications.

The asset has been partnered to Brenig Therapeutics, which will lead clinical development. BT-409 represents the first clinical-stage program originating from Mwyngil’s platform of protein–protein interaction (PPI) and cell-surface receptor modulators.

Why BT-409 Stands Out?

BT-409 is an orally administered small molecule. It is designed to selectively inhibit the NLRP3 inflammasome.

Preclinical data show central nervous system (CNS) penetration. This suggests the drug can directly modulate neuroinflammation within the brain.

Many existing NLRP3 inhibitors are peripherally restricted. BT-409 is intended to overcome that limitation.

Phase 1 Study Objectives

The Phase 1 program will be conducted in healthy volunteers. Key objectives include:

• Assessing safety and tolerability

• Characterizing pharmacokinetics

• Supporting rapid transition into patient studies

Positive results would enable advancement into neuroinflammatory disease trials.

Expanding NLRP3-Focused Pipeline

Mwyngil is building a broader pipeline around NLRP3 biology. Programs in development include:

• Brain-permeable NLRP3 inhibitors for obesity and cardiometabolic disease

• A systemically bioavailable NLRP inhibitor for chronic kidney disease (CKD)

Clinical trial initiation for both programs is planned for 2026.

Beyond NLRP3: GPR75 Program

Mwyngil is also developing a potentially best-in-class GPR75 inverse agonist. The program targets:

• Obesity

• Related cardiometabolic conditions

First-in-human studies are planned for 2027.

About Mwyngil Therapeutics

Mwyngil Therapeutics is a clinical-stage biotechnology company. The company focuses on small-molecule therapies for:

• Neuroinflammatory diseases

• Immunometabolic disorders

• Inflammatory conditions

Mwyngil leverages a proprietary AI/ML platform from partner Expert Systems Inc. The platform is used to optimize selectivity, absorption, and tissue distribution

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