Brenig Therapeutics Advances Two CNS Programs Into Key Clinical Milestones

Brenig Therapeutics Advances Two CNS Programs Into Key Clinical Milestones

Brenig Therapeutics, Inc., a clinical-stage biotech, has initiated its first-in-human study for BT-409, a brain-selective NLRP3 inflammasome inhibitor. The company also shared progress on BT-267, its CNS-optimized LRRK2 inhibitor for Parkinson’s disease.

BT-409 Enters First-in-Human Clinical Testing

BT-409 is a small-molecule, brain-selective NLRP3 inhibitor licensed from Mwyngil Therapeutics.

The compound was discovered and optimized using Brenig’s AI- and machine learning–enabled platform, with emphasis on:

  • Central nervous system penetration
  • High potency
  • Pharmacokinetics suitable for chronic neurological use

Phase 1 Study Design

Brenig has initiated a Phase 1 SAD/MAD study in healthy volunteers.

The trial will evaluate:

  • Safety and tolerability
  • Pharmacokinetics
  • Pharmacodynamic activity

First dosing is expected in early Q1 2026.

What Comes Next?

If Phase 1 is successful, Brenig plans proof-of-concept studies in:

  • Multiple sclerosis
  • Parkinson’s disease

The program targets neuroinflammation and neurodegeneration via central inflammasome inhibition.

BT-267 Continues Clinical Momentum in Parkinson’s Disease

BT-267 is a highly selective, brain-optimized LRRK2 inhibitor designed to maximize CNS exposure while limiting peripheral effects.

Early clinical data show:

  • Favorable pharmacokinetics
  • Sustained CNS exposure above predicted LRRK2 IC50 levels
  • Encouraging safety and tolerability

Upcoming Studies

Brenig plans to:

  • Initiate a Phase 1b study
  • Begin start-up activities for a Phase 2 proof-of-concept trial in Parkinson’s disease

Both are targeted for early 2026.

Strategic Focus: CNS-First Drug Design

Both BT-409 and BT-267 reflect Brenig’s strategy of precision CNS drug engineering.

Key design principles include:

  • High brain permeability
  • Strong target selectivity
  • Disease-modifying potential

The company is positioning both programs for efficient clinical translation.

About Brenig Therapeutics

Founded in 2021, Brenig Therapeutics focuses on small-molecule therapies for neurodegenerative diseases.

The company raised $65 million in Series A financing in July 2024, led by NEA, with participation from OrbiMed, Torrey Pines, and others. Brenig’s mission is clear: target core disease mechanisms and move faster from discovery to patients.

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