BioLineRx (BLRX) Commences BL-7040 Phase II
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BioLineRx (Nasdaq: BLRX) 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.
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.
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