BioLineRx (NASDAQ:BLRX) (TASE:BLRX) a biopharmaceutical development company, announced today that it has received approval from the Israeli Ministry of Health for commencing a Phase II clinical trial of BL-7040, an orally available molecule for treating Inflammatory Bowel Disease (IBD).
This Phase II trial will be an open-label study to evaluate the efficacy, pharmacodynamics, safety and tolerability of oral BL-7040 in up to 20 patients with moderately active ulcerative colitis, a type of IBD. Patients will be treated for up to five weeks with BL-7040: 12mg/day for up to three weeks followed by 40mg/day for two additional weeks. The clinical trial will be carried out at two sites in Israel: Sourasky Medical Center in Tel Aviv and Hadassah Medical Center in Jerusalem.
BL-7040 was shown to suppress inflammation in pre-clinical studies. In these studies, BL-7040 treatment led to amelioration of parameters associated with inflammatory bowel disease. BL-7040's efficacy in these studies was shown to be highly significant and comparable to that of dexamethasone, a steroid used routinely for IBD but which is associated with multiple side effects. BL-7040's safety was also demonstrated in pre-clinical studies, as well as in previous clinical trials.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “We are eagerly anticipating the commencement of this clinical trial on BL-7040's efficacy which, if successful, could herald a breakthrough in the treatment of IBD. Many of today's treatments have severe side effects and are not effective in up to 40% of patients. BL-7040 is an orally available treatment for Inflammatory Bowel Disease with a novel mechanism of action, which we believe will have greater efficacy and an improved safety profile."About Inflammatory Bowel Disease (IBD) IBD is a chronic, inflammatory, gastrointestinal disease characterized by chronic abdominal pain, discomfort, bloating and bleeding. The two major types of IBD are ulcerative colitis (UC) and Crohn’s disease. There are a variety of treatment options available for IBD but all these treatments are associated with significant side effects. In addition, 25-40% of patients do not respond to treatment. Therefore, there remains a significant unmet medical need for novel, efficacious treatments with a favorable safety profile. In 2009 the IBD population was estimated at 2.3 million in the seven major markets (US, Japan, France, Germany, Italy, Spain and UK) and is forecasted to grow to 2.9 million in 2019. The IBD market in the seven major markets was estimated at $3.5 billion in 2009 and is forecasted to grow to $5.6 billion in 2019.