First Wave Bio Inc., a biopharmaceutical company developing novel therapeutics for the treatment of inflammatory bowel disease (IBD) and related autoimmune disorders, today announced that it has received regulatory approval to begin clinical testing of its lead product candidate (FW-424) for the treatment of ulcerative colitis (UC). FW-424 is a gut-restricted, small molecule that can be formulated for either oral or rectal administration, and is being developed to address the needs of patients not served by current UC drugs.

UC is a chronic disorder that causes inflammation resulting in ulcers of the inner lining of the large intestine (colon) and rectum. As with other forms of IBD like Crohn’s disease, UC can be debilitating and in some cases, is life-threatening. The cause of UC is unknown and aside from surgical removal of the colon, it has no cure. UC drugs work to reduce the signs and symptoms of the disease and for some individuals, can bring about remission. Over time, these agents often lose their effectiveness, particularly in patients with moderate to severe disease. Moreover, many of the most effective UC drugs are associated with severe side effects, must be given by infusion or injection, and are very costly.

Preclinical studies with FW-424 demonstrate properties highly desirable for a successful UC drug: reducing levels of pro-inflammatory cytokines, killing pathogenic lamina propria T cells, and blocking pathogenic Wnt signaling, a key step to promote mucosal healing. In animal models of IBD, FW-424 demonstrates potent therapeutic activity equal to or surpassing competitor compounds. Because FW-424 has low oral bioavailability and is gut restricted, the potential for systemic side effects, including unwanted immunosuppression should be reduced.

"The First Wave team is excited to reach this critical milestone," said Dr. Gary D. Glick, CEO and co-founder of First Wave Bio. "We are committed to help expand the potential treatment options for UC patients, and are excited by the opportunity FW-424 presents across the disease spectrum, from mild all the way to the most severe forms of UC."

About First Wave Bio Inc.

First Wave Bio Inc. is a privately held biopharmaceutical company based in Ann Arbor, MI. The company was founded by an experienced group of scientists, physicians, executives, and investors with a track record of building high-value, patient-focused biotech companies. Members of the First Wave team have spent decades researching the causes for autoimmune diseases like IBD and have led the development of several promising new therapies for them