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BioLineRx Announces New Positive Results in Phase 2a trial for Orally Available Inflammatory Bowel Disease Treatment
Date:11/26/2013

lerability of BL-7040 in patients with moderately active ulcerative colitis. Twenty-two patients were enrolled in the multi-center, proof-of-concept clinical trial, and 16 patients completed the study (five weeks of treatment plus two weeks of follow-up). During the five-week treatment period, patients received 12mg/day for up to three weeks, followed by 40mg/day for two additional weeks.

Statistical analyses were performed on the 16 patients completing five weeks of treatment, and the primary endpoint of clinical response was assessed by the Mayo score reduction between the last days of treatment compared to baseline. Fifty percent of patients met the primary endpoint, while the remaining patients demonstrated a stable clinical condition or minor improvement. Fifty-six percent of patients recorded a decrease in rectal bleeding of at least 1 point and 69% had a rectal-bleeding sub-score of ≤1 (and in six of these 11 patients no rectal bleeding was seen at all). Fifty percent of patients completing study treatment also met the secondary endpoint assessed by the partial Mayo score, while all other patients were clinically stable or demonstrated some improvement. Furthermore, 50% demonstrated mucosal healing evaluated by endoscopy sub-score measurements.

The drug was highly safe and well tolerated by the study participants, with very low incidence of drug related mild-moderate adverse events (AE) and one serious AE not related to BL-7040 treatment. Patients were very satisfied from the safety and tolerability profile of the treatment and emphasized the ease of oral administration.

About BL-7040         
BL-7040 is an orally available, synthetic oligonucleotide with a unique dual activity, being developed for the treatment of inflammatory bowel disease (IBD). It has a specific agonist effect on a receptor involved in the immune system and inflammatory reactions called Toll-Like Receptor 9 (TLR
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