- BT051 IND Clearance
- Phase 1 Clinical Trial Initiation
CONCORD, Mass. — Bacainn Therapeutics, Inc., a Company developing novel therapies to address uncontrolled inflammation, announced today FDA’s Clearance of the IND for BT051, and initiation of a Phase 1 Clinical Trial with patient dosing expected in the coming months. BT051 is a first-in-class approach to modulating the migration and activation of specific innate immune cells (neutrophils) and is being developed to treat various acute medical conditions including ulcerative colitis.
The advancement of BT051 into the clinic was based on its favorable profile exhibited in pre-clinical safety testing, along with its GI tract-restricted distribution and its demonstration of potent and selective activity against human primary neutrophils in a model of inflammation. The Phase 1 clinical trial is evaluating various dose levels of BT051 for safety, tolerability and pharmacokinetics in a double-blind, placebo-controlled study in healthy volunteers.
“We are thrilled by the remarkable progress made by the Bacainn team and excited about the advancement of the clinical development of BT051,” said CEO Ronnie Farquhar. “Our partnership with University of Massachusetts Medical School provided access to decades’ worth of experience around neutrophil biology, as well as sophisticated assay systems, which greatly enabled our discovery process.”
“As an oral, gut-restricted anti-inflammatory agent, BT051 is well positioned as a novel therapeutic approach for patients with moderate to severe ulcerative colitis,” said Chris Stevens, MD, Bacainn’s Chief Medical Officer.
“BT051 entering the clinic is very welcome news,” said Dr. Adam Cheifetz, Director, Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center. “I am excited about this novel approach that could help us avoid the use of corticosterioids.”
Top-line results from the Phase 1 trial of BT051 are expected by the end of 2020.
BT051 is a rationally designed new chemical entity which was discovered by Bacainn Therapeutics, Inc. in collaboration with University of Massachusetts Medical School. The molecule is designed for once daily oral dosing and is restricted to the GI tract. It takes advantage of Bacainn’s insights into the mechanisms responsible for controlling neutrophil migration into the lumen of the GI tract, as well as these immune cells’ subsequent activation. The pathology of moderate to severe ulcerative colitis results, at least in part, from the highly damaging effects of dysregulated neutrophil accumulation and activation.
About Bacainn Therapeutics
Bacainn Therapeutics is a spin-out company from University of Massachusetts Medical School and is based on the extensive insights into neutrophil biology generated by Dr. Beth McCormick’s Laboratory. The Company takes its name from the Irish word for barrier, reflecting Dr. McCormick’s contributions into understanding neutrophil transepithelial migration, as well as her family’s historic roots. Bacainn was co-founded in 2017 by Morningside Ventures and recently closed a 25 Million financing to advance the ongoing clinical study in addition to supporting further pipeline build.
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