Brenig Therapeutics, a clinical-stage biotech, has announced the launch of a first-in-human study for its novel neurodegenerative therapy -- 

BT-409, a brain-selective NLRP3 inflammasome inhibitor. 

 

BT-409, licensed from Mwyngil Therapeutics, was discovered using Brenig’s proprietary AI- and machine learning-driven platform, optimized for central nervous system penetration, potency, and pharmacokinetics suitable for chronic neurological conditions.

 

The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026. Researchers will assess the drug’s safety, tolerability, and pharmacokinetic and pharmacodynamic profiles in healthy volunteers.

 

If Phase 1 is successful, Brenig plans to move BT-409 into proof-of-concept studies for Multiple Sclerosis and Parkinson’s disease, testing its potential to modulate neuroinflammation and neurodegeneration.

 

“BT-409 exemplifies our ability to design neuroinflammation-targeting molecules with the selectivity and pharmacology required for neurodegenerative disease,” said Megan McGill, MD, PhD, CEO of Brenig. 

 

“We are focused on translating this program efficiently into the clinic with the goal of delivering meaningful new treatment options for patients affected by neuroinflammatory and neurodegenerative diseases, and we look forward to exploring the potential of BT-409 across multiple neurologic indications.”

 

Brenig also reported progress on BT-267, a CNS-optimized LRRK2 inhibitor engineered for high brain permeability, potency, and selectivity. Early clinical data show sustained CNS exposure at levels expected to exceed LRRK2 IC50 thresholds, with a favorable safety profile.

 

The company plans to start a Phase 1b study and begin Phase 2 proof-of-concept trials in Parkinson’s disease patients in early 2026.

 

“The emerging clinical profile of BT-267 supports its potential as a best-in-class LRRK2 inhibitor,” said Tien Dam, Chief Medical Officer of Brenig. “We believe CNS-optimized LRRK2 inhibition remains one of the most compelling therapeutic strategies in Parkinson's disease, and we are focused on advancing BT-267 efficiently into patient studies.”