Brenig Therapeutics Advances Two CNS Programs Into the Clinic

Brenig Therapeutics Advances Two CNS Programs Into the Clinic

By, Admin 20 January 2026

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!