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Brenig Therapeutics Initiates Phase 1 Trial of BT-267 for Parkinson's Disease

  • Brenig Therapeutics has commenced a first-in-human trial of BT-267, a novel LRRK2 inhibitor, for both idiopathic and LRRK2-associated Parkinson's disease.
  • The Phase 1 trial will initially assess the safety and tolerability of BT-267 in healthy volunteers, followed by proof-of-concept studies in Parkinson's patients.
  • Preclinical data suggest BT-267 has a superior safety profile and exceptional pharmacokinetics, including high cerebrospinal fluid penetration.
  • BT-267's development leverages advanced computational drug design and AI/ML to identify predictive biomarkers for Parkinson's disease.
Brenig Therapeutics has announced the start of a Phase 1 clinical trial for BT-267, a selective LRRK2 inhibitor, as a potential treatment for Parkinson's disease. The trial, which began in November 2024, will evaluate the safety and tolerability of BT-267 in healthy volunteers before moving to proof-of-concept studies in patients with idiopathic Parkinson's disease.
BT-267 is designed to address both idiopathic and LRRK2-associated Parkinson's disease. The development of BT-267 was supported by a $65 million financing round led by New Enterprise Associates.

Preclinical Profile of BT-267

Preclinical data indicates that BT-267 has a favorable safety profile compared to other LRRK2 inhibitors. GLP toxicology studies showed minimal lung or kidney morphological changes at the highest doses tested. The compound also exhibits exceptional pharmacokinetics, including a high cerebrospinal fluid (CSF) to plasma unbound ratio, suggesting effective brain penetration.

Innovative Development Approach

BT-267's development incorporates computer-aided drug design, AI/ML computational pharmacology, biomarker models, and structural biology expertise. This approach aims to identify predictive biomarkers that could help position BT-267 as a disease-modifying therapy for Parkinson's disease, including idiopathic cases without known genetic drivers.

Parkinson's Disease Context

Parkinson's disease is a progressive neurodegenerative disorder affecting millions worldwide. Current treatments primarily manage symptoms, with a significant unmet need for therapies that can modify the disease's progression. LRRK2 is a promising therapeutic target, and BT-267 represents a potential advancement in this area.
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Reference News

[1]
Brenig Therapeutics Announces the Initiation of First-in-Human Clinical Trial of BT-267, a ...
prnewswire.com · Nov 26, 2024

Brenig Therapeutics initiated a first-in-human trial for BT-267, a best-in-class LRRK2 inhibitor for Parkinson's disease...

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