Bridge Biotherapeutics said Monday that it has submitted its first investigational new drug application (IND) with the U.S. Food and Drug Administration to initiate a phase 1 clinical trials for BBT-401, an ulcerative colitis candidate drug.
The FDA will review the IND application for safety to assure that research subjects will not be subject to unreasonable risks. If the FDA clears the application, the company will conduct phase 1 clinical trial through Celerion, an early clinical contract research organization (CRO), in the U.S.
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.
Recently, the demand for a safe first-level treatment has increased as 5-aminosalicylic acid (5-ASA), the current first level treatment, only has a response rate of 50 percent, while the initial symptom remission rate is as low as 20 percent. Such low response rate has led patients to gradually change their treatment to expensive anti-TNF antibody therapies such as Enbrel, Remicade or Humira.
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.
“Over the past two years, the company has successfully applied IND procedures, while simultaneously implementing the goal of establishing a research and development teams and financing preclinical development,” Bridge Biotherapeutics CEO Lee Jung-kue said. “The process was rewarding as it showed that Korean biotech companies could also develop innovative new drugs at a global level.”
The company plans to continue writing Korea’s new history step by step, through the successful completion of phase I clinical trials, Lee added.
Bridge Biotherapeutics also plans to complete pre-clinical test for BBT-877, a fibrosis treatment candidate, and apply for IND within the year.
<© Korea Biomedical Review, All rights reserved.>