Drug development company BiolineRX Ltd. (TASE:BLRX) reported good results for its phase IIb clinical trial for its schizophrenia drug. The trial achieved its main target as defined by the US Food and Drug Administration (FDA) in proving that the drug is both safer and more effective than the group of patients that took a placebo. The drug was found to be more effective in treating false thoughts and negative symptoms of the disease such as depression and apathy.
In addition, the trial was successful, although not outstandingly so, in other variables that were not central, but important for selling the rights to a major pharmaceutical company. Thus the drug has proved effective in improving the quality of the patient's cognitive functioning, something which existing treatments cannot do.
Bioline's schizophrenia drug has also proven to be safer than Risperidone, a competitive medications already on the market. The trial did not show side effects in the metabolism, or heart rate as in Risperidone but there were motor side effects (difficulty in movement) but not at a higher level than Risperidone.
After the trial results were published today Bioline's share jumped 14% on the TASE, although it fell back to finish the day up 1.85% to NIS 2.31, giving a market cap of NIS 260 million.
Bioline chairman and Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) VP new venture Dr. Aharon Schwartz said that the company planned commercializing the product within a few months. He said, "We have said in the past that we are negotiating with a number of companies who asked to wait until we had the trial's results."
He added, "Analysis of the results from the point of view of cognitive parameters is the icing on the cake."
Published by Globes [online], Israel business news - www.globes-online.com - on September 14, 2009
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