BioLineRx has announced 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."