Brenig Therapeutics has initiated a first-in-human (FIH) Phase 1 study for BT-409, its brain-selective NLRP3 inflammasome inhibitor. The company also shared updates on BT-267, a CNS-optimized LRRK2 inhibitor.
BT-409 Enters First-in-Human Studies
BT-409 targets neuroinflammation through selective inhibition of the NLRP3 inflammasome. Key highlights:
- Small-molecule therapy licensed from Mwyngil Therapeutics
- Designed using AI- and ML-enabled discovery platforms
- Optimized for CNS penetration, potency, and chronic dosing
Phase 1 Study Design
The Phase 1 trial includes both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Study objectives:
- Assess safety and tolerability
- Characterize pharmacokinetics and pharmacodynamics
- Enroll healthy volunteers
First dosing is expected in early Q1 2026.
Planned Indications for BT-409
Following successful Phase 1 completion, Brenig plans to advance BT-409 into proof-of-concept studies.
Target indications include:
- Multiple Sclerosis
- Parkinson’s disease
The program explores central inflammasome inhibition in neurodegeneration and lysosomal-neuronal homeostasis.
BT-267: LRRK2 Program Continues to Progress
Brenig also reported progress with BT-267, a highly selective LRRK2 inhibitor. Key attributes:
- Engineered for robust CNS exposure
- Designed to minimize peripheral and systemic effects
- Sustained brain levels exceeding LRRK2 IC50 thresholds
Early data show a favourable pharmacokinetic and safety profile.
Next Clinical Steps for BT-267
Planned milestones include:
- Phase 1b study initiation
- Start-up of a Phase 2 proof-of-concept trial in Parkinson’s disease
- Expected timeline: early 2026
Company Snapshot
- Founded in 2021
- $65 million Series A raised in July 2024
- Lead investors include NEA, OrbiMed, BioGeneration Ventures, and Torrey Pines
Brenig focuses on small-molecule therapies targeting fundamental mechanisms in neurodegenerative disease.
