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BioLineRx receives Israeli approval for commencing phase II clinical trial of BL-7040

Biopharmaceutical development firm BioLineRx 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 open-label Phase II study will 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.

The clinical trial will run up to five weeks. Patients will be treated with 12mg/day of BL-7040 up to three weeks followed by 40mg/day for two additional weeks.

BioLineRx CEO Kinneret Savitsky said the company is anticipating the commencement of this clinical trial on BL-7040’s efficacy which, if successful, could lead to a possible treatment of IBD.

"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," Savitsky said.

The trial will be conducted at two sites in Israel, which include Sourasky Medical Center in Tel Aviv and Hadassah Medical Center in Jerusalem.

The company said BL-7040 was shown to suppress inflammation in pre-clinical studies.