Landos Biopharma has recently released data from their Phase 2 trial of BT-11, a treatment for ulcerative colitis. The results were positive, making this therapy a possible viable treatment for the chronic, inflammatory disease. Not only is this data exciting for ulcerative colitis patients, but it will hopefully aid Landos in creating more treatments for autoimmune diseases.
About Ulcerative Colitis
Ulcerative colitis is a form of inflammatory bowel disease that impacts approximately 700,000 people throughout the United States. It is characterized by sores and ulcers in the large intestine, which then lead to symptoms like weight loss, nausea, anemia, cramping, joint pain, fatigue, loose bowel movements, blood in the stool, and rash. Unfortunately, there is no cure for this condition; however, treatment can lead to remission. Doctors often prescribe biologics, corticosteroids, antibiotics, immunomodulators, and aminosalicylates. In very severe cases, surgery may be necessary to remove part of or the entirety of the colon.
BT-11 is a novel, gut restricted small molecule that targets the LANCL2 pathway within the gastrointestinal tract. The drug activates this pathway, therefore regulating any interaction between the metabolic and immunological signals. This regulation is able to decrease inflammation. It is administered orally.
About the Study
This Phase 2 proof-of-concept trial lasted for twelve weeks, with a goal of evaluating the efficacy and safety of BT-11. Researchers also examined dosing and clinical remission. 198 patients with mild to moderate ulcerative colitis throughout 53 sites participated in this double-blind, placebo-controlled, randomized, parallel-group study.
In order to best evaluate clinical remission, researchers utilized a Mayo score with three components: rectal bleeding, endoscopic sub-scores, and stool frequency sub-scores. They found that 31.8% of patients receiving the 1,000 mg dose reached remission, as did 30.3% of those in the 500 mg dose group.
Over 40% of patients receiving BT-11 saw normalized fecal calprotectin levels in just two weeks, which can be compared to only 21% of those in the placebo group. In addition, researchers found that the therapy was well-tolerated and gut-restricted.
It is these positive results that excite researchers. They are planning further trials, and Landos hopes to expand its work in treatments for autoimmune conditions.
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