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Bacainn Therapeutics and University of Massachusetts Medical School begin Phase 1 clinical trial of BT051 for ulcerative colitis

Thu, 06/18/2020 - 10:29
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Bacainn Therapeutics has initiated a Phase 1 clinical trial, of BT051, 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 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. Patient dosing expected in the coming months.

BT051 is a rationally designed new chemical entity which was discovered by Bacainn Therapeutics, in collaboration with University of Massachusetts Medical School (UMass). Biologics to modulate the migration and activation of specific innate immune cells, called neutrophils, discovered in the lab of Dr Beth McCormick from UMass Medical School, have been licensed by Bacainn Therapeutics, to develop treatments for various acute medical conditions, including ulcerative colitis.

"The collaboration with Bacainn has been fundamentally critical in advancing our biological discoveries in GI pathophysiology towards the development of novel therapeutics to treat patients with ulcerative colitis—and perhaps other chronic inflammatory diseases, as well," said McCormick, the Worcester Foundation for Biomedical Research Chair, vice chair and professor of microbiology & physiological systems, and founding director of the UMass Center for Microbiome Research. "The Bacainn team shared our vision of how to bring a drug of this unique class into this phase of clinical testing while at the same time the my lab was ideally poised to understand how to obtain results to move the development forward quickly and effectively."

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.

"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."

The advancement of BT051 into the clinic was based on its favourable 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 quest for new treatment options, despite the backdrop of rapidly developing new therapies, is essential and highlights the complexity of this disease given there remains many unanswered questions regarding the causes and course of the disease, its management and treatment," added McCormick.