Brenig launches Phase 1 trial of small molecule therapy for MS
First-in-human study will assess BT-409's safety in healthy volunteers
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Brenig has launched a Phase 1 trial for BT-409, a small molecule therapy for MS.
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BT-409 targets the NLRP3 inflammasome, which drives abnormal inflammation in MS.
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The trial will assess BT-409's safety in healthy volunteers, with future studies planned.
Brenig Therapeutics has launched an early Phase 1 clinical trial to evaluate its experimental small molecule BT-409Â in healthy volunteers.
The therapy is being developed for people with multiple sclerosis (MS) and other chronic neurologic conditions. It is aimed at blocking inflammatory responses by targeting the NLRP3 inflammasome, an immune complex that is abnormally activated in these conditions.
The first-in-human study, which seeks to assess the safety, tolerability, and pharmacological properties of increasing doses of BT-404, given once or multiple times, is expected to dose its first participants soon.
If successfully completed, the study will pave the way for proof-of-concept studies in people with MS and Parkinson’s disease.
“BT-409 exemplifies our ability to design neuroinflammation-targeting molecules with the selectivity and pharmacology required for neurodegenerative disease,” Megan McGill, MD, PhD, Brenig’s CEO, said in a company press release. “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.”
Small molecule therapy targets key protein complex
MS is caused by abnormal inflammatory attacks that damage healthy parts of the brain and spinal cord. The mechanisms behind this process are not yet fully understood, but evidence suggests the NLRP3 inflammasome may play a role in driving MS and other diseases.
The NLRP3 inflammasome is a protein complex that is activated when it senses the presence of infectious pathogens or certain damage patterns. When activated, it triggers the sustained release of pro-inflammatory molecules, leading to a strong inflammatory response.
In normal circumstances, the NLRP3 inflammasome is essential for fighting infections or helping the body respond to tissue damage. But this complex is abnormally active in many neurodegenerative diseases, leading to excessive inflammation and further nerve damage.
BT-409 is a small molecule designed to selectively inhibit the NLRP3 inflammasome in the brain while minimizing off-target effects. The drug was first developed by Mwyngil Therapeutics using the company’s proprietary artificial intelligence and machine learning drug accelerator platform, and was licensed to Brenig last year.Â
According to the company, BT-409 has demonstrated promising safety and pharmacological profiles in preclinical models of neuroinflammation.
After completing the ongoing Phase 1 clinical trial in healthy volunteers, Brenig is planning to advance BT-409 into studies in MS and Parkinson’s. The goal is to determine whether BT-409 reduces neuroinflammation and neurodegeneration as intended in these populations. Researchers also aim to understand the mechanisms behind its effects better.
