The primary objective of the phase I trial was to evaluate the safety and tolerability of escalating doses of BL-1020.
The study results showed that BL-1020 was well tolerated and showed an improved safety profile reducing extrapyramidal symptoms that are experienced with currently available therapies.
“The current generation of anti-schizophrenia drugs is effective in less than 60% of the patients who suffer from schizophrenia, and even in these patients, it produces adverse effects that cause the patients to discontinue medication,” commented Professor Michael Davidson, director, Department of Psychiatry, Sheba Medical Center.
Results from the phase I trial indicate that BL-1020 might be better tolerated than currently available drugs.
In addition BL-1020 is the only antipsychotic with the potential to increase the activity of the neurotransmitter GABA which appears to be deficient in schizophrenia. Increased GABA activity might also reduce anxiety and improve cognitive function in patients suffering from schizophrenia.
The secondary objectives of the trial were to determine the pharmacokinetics of BL-1020, and to assess its ability to block activity of the neurotransmitter dopamine, implicated in schizophrenia.
The effect of BL-1020 on dopamine levels was assessed by monitoring serum prolactin, a surrogate marker for dopamine antagonism. The pharmacokinetics of BL-1020 were linear across the range of doses studied.