Bridge Biotherapeutics said Tuesday that it plans to start phase 1 clinical trials for BBT-401, an ulcerative colitis candidate drug.
Ulcerative colitis is a common inflammatory bowel disease such as Crohn's disease. It is a recurrent inflammatory disease with multiple ulcers in the mucosa of the colon.
The initiation of the clinical trials comes after no further supplemental data request from the U.S. Food and Drug Administration (FDA) regarding the company’s investigational new drug (IND) application in the 30-day period after its submittal. The company applied for the IND on Jan. 26.
During the period, the company took steps to successfully begin its clinical trials by applying for a review of the data to the Institutional Review Board (IRB) and preparing to recruit patients for the clinical trials.
The company plans to begin to check the eligibility of healthy volunteers in early March and start the single ascending dose (SAD) trial, which gradually increases the dose from the low dose to the high dose, for the first patient group on March 21. During the SAD testing, the company aims to test seven treatments, which will also lead to confirm the food-effect bioavailability of the drug.
Bridge Biotherapeutics aims to complete phase 1 clinical trials, including SAD and Multiple Ascending Dose (MAD) tests, by the end of this year.
The company expects BBT-401 will become a useful alternative treatment for patients who do not respond or have little improvement to 5-ASA drugs, which accounts for 70 percent of the first-level prescription used for patients suffering from ulcerative colitis.
BBT-401 has demonstrated excellent anti-inflammatory and mucosal layer efficacy in preclinical animal efficacy testing, and has also shown high safety in preventing maximum tolerable dose at 10-gram dosage through a preclinical toxicity testing, the company said. The treatment also remains in the intestine and is not absorbed by the whole body. Therefore, it has no concerns regarding side effects caused by steroids or anti-TNF antibodies, which act on the entire body, it added.
The company was also in the process of registering patents for BBT-401 in 26 countries as of the end of last year.
“Korean researchers have come to a point where safety and efficacy of candidates discovered through intermediary research on proteins can be confirmed on humans,” Bridge Biotherapeutics CEO Lee Jung-kue said. “We are also pleased that the company was able to begin clinical studies in the U.S. in a relatively short period."
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