BL-1020: Phase II/III discontinued

BioLineRx discontinued the double-blind, international Phase II/III CLARITY trial after a pre-planned interim analysis of 168 evaluable patients experiencing an acute exacerbation of schizophrenia showed that oral BL-1020 would not meet the primary endpoint of improving cognition from baseline to week 6 vs. Risperdal risperidone. The interim analysis also showed that BL-1020 would not meet the secondary endpoints of improving cognition at weeks 12 and 24 vs. Risperdal. BioLineRx did say that BL-1020 showed "positive trends" on the pre-specified parameters of consistent timing and social cognition test scores. The interim analysis was performed by a blinded, independent DMC to provide BioLineRx with an estimated total number of patients required to achieve statistical significance on the trial's cognitive endpoints. The company said it will perform a complete analysis of unblinded data from all 230 patients enrolled before determining next steps. The trial was slated to enroll about 435 patients.

BioLineRx said the trial discontinuation will result in a reduction of about $6-$7 million in R&D expenses for 2013 and part of 2014. The company now expects its $28 million in cash to fund operations into 2015. In its 2012 earnings released in March, BioLineRx said its existing cash would fund programs through 2014. The company's next most advanced compound is BL-1040. The biodegradable injectable liquid polymer designed to support damaged heart tissues following a myocardial infarction (MI) is in the pivotal PRESERVATION I trial to prevent ventricular remodeling and congestive heart failure (CHF) following acute MI. The trial is expected to complete in 2014. Ikaria Inc. (Hampton, N.J.) has exclusive, worldwide rights from BioLineRx to develop and commercialize BL-1040 under a 2009 deal (see BioCentury, July 13, 2009). ...