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Brenig Therapeutics, Inc. (Brenig), a clinical-stage biotechnology company advancing small-molecule therapies for neurodegenerative diseases, announced the initiation of a first-in-human (FIH) clinical study of BT-409, the company’s novel, brain-selective NOD-, LRR-, and pryin domain-containing protein 3 (NLRP3) inflammasome inhibitor. The company also provided an update on the continued clinical advancement of BT-267, its highly selective, brain-optimized leucine rich repeat kinase 2 (LRRK2) inhibitor.
BT-409, a small-molecule NLRP3 inhibitor licensed from Mwyngil Therapeutics, was discovered and optimized using a proprietary artificial intelligence (AI)- and machine learning (ML)-enabled discovery and development platform, with a design focus on central nervous system (CNS) penetration, potency, and pharmacokinetic properties suitable for chronic neurologic indications.
The company has initiated a phase 1 single ascending dose (SAD)/multiple ascending dose (MAD) study, with first dosing anticipated in early Q1 2026. The study is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of BT-409 in healthy volunteers.
Subject to successful completion of phase 1, Brenig plans to advance BT-409 into proof-of-concept studies in Multiple Sclerosis and Parkinson’s disease, evaluating the therapeutic potential of central inflammasome inhibition in neuroinflammation and neurodegeneration, including potential interactions with pathways involved in lysosomal and neuronal homeostasis.
“BT-409 exemplifies our ability to design neuroinflammation-targeting molecules with the selectivity and pharmacology required for neurodegenerative disease,” said Megan McGill, MD, PhD, chief executive officer of Brenig. “We are focused on translating this programme 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 reports continued progress in its clinical programme for BT-267, a LRRK2 inhibitor rationally designed to achieve robust CNS exposure while minimizing peripheral and systemic effects. Early clinical data demonstrate a favourable pharmacokinetic profile supporting sustained CNS exposure at levels predicted to exceed LRRK2 IC50 thresholds, with an encouraging safety and tolerability profile to date.
The company plans to initiate a phase 1b study and commence start-up activities for a phase 2 proof-of-concept trial of BT-267 in individuals with Parkinson’s disease in early 2026.
BT-267 has been engineered for high brain permeability, potency, and selectivity—attributes believed to be critical for disease-modifying LRRK2 inhibition in Parkinson’s disease.
“The emerging clinical profile of BT-267 supports its potential as a best-in-class LRRK2 inhibitor,” said Tien Dam, MD, chief medical officer of Brenig Therapeutics. “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.”
Founded in 2021 through a venture creation initiative led by Torrey Pines Investment and OrbiMed, Brenig Therapeutics secured a $65 million Series A financing in July 2024, led by NEA with participation from BioGeneration Ventures, OrbiMed, Torrey Pines, and other US-based healthcare investors. Brenig is dedicated to developing innovative small-molecule therapies to address fundamental disease mechanisms and accelerate clinical translation for neurodegenerative diseases. BT-409 was licensed from Mwyngil Therapeutics.
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