BL-1020: Phase II/III ongoing
Next quarter, BioLineRx will conduct an interim analysis of data from about 235 patients in the Phase II/III CLARITY trial comparing oral BL-1020 vs. Risperdal risperidone. BioLineRx said the updated analysis of BL-1020 earlier this month in the Phase IIb EAGLE trial to treat schizophrenia, as well as "other positive ad-hoc analyses" and BL-1020's "excellent track record" in clinical and preclinical studies prompted the company to conduct an interim analysis. The double-blind, placebo-controlled, Romanian and Indian CLARITY trial is enrolling 435 patients experiencing an acute exacerbation of schizophrenia.
The updated analysis from the EAGLE trial in 363 schizophrenia patients showed that BL-1020 significantly improved cognitive function from baseline as measured by Brief Assessment of Cognition in Schizophrenia (BACS) scores by 97% compared to placebo and by 57% compared to risperidone. In the original analysis of data from the overall population, which did not take testing times into account, BL-1020 significantly improved cognitive function from baseline by 40% compared to placebo and by 39% compared to risperidone (see BioCentury, Oct. 15). ...