BiolineRX Ltd. (TASE:BLRX) has successfully completed the Phase I clinical trial of BL-1020 for the treatment of schizophrenia. The trial demonstrated that the compound was well tolerated and demonstrated biochemical evidence of dopamine blockade which is indicative of efficacy.
The trial showed that BL-1020 had no effect on the central nervous system, a common side effect of psychosis drugs, including schizophrenia treatments. The effectiveness of current schizophrenia drugs vary. Some drugs are highly effective, but have severe side effects, which can deeply affect the patient’s quality of life.
To penetrate this market, a new schizophrenia drug must demonstrate that is both safer than current drugs and has less severe side effects. Patients and physicians hesitate replacing proven drugs for even slightly more effective ones, but some will take the risk if it can be demonstrated that the side effects of the new treatment are substantially reduced.
On the basis of laboratory and animal tests, BiolineRX believes that BL-1020 affects the mechanism that bypasses the cause of most of the classic side effects of schizophrenia drugs. The present trial supports this notion, but more trials will be needed to prove it at the statistically meaningful level necessary for marketing, assuming, of course, that the drug is demonstrated to be effective and approved for marketing in the first place.
BioLineRx presented the data at the 2007 American Psychiatric Association (APA) annual meeting last week. The company added that a Phase II clinical trial for BL-1020 to determine the maximum tolerated dose in schizophrenic patients was due to begin in the end of June 2007.
The trial was randomized, double blind, placebo-controlled, dose-escalation, single center study in healthy adult men aged 21-45.
BiolineRX has a market cap of NIS 82 million, 82% of its IPO value six months ago. The share rose 4% after the announcement.
Published by Globes [online], Israel business news - www.globes.co.il - on May 29, 2007
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