Obecure Ltd., a subsidiary of Bio-Light Israeli Life Science Investments
Ltd. (TASE:BOLT), has received notice of allowance from the US Patent
Office for its two key patent applications covering methods of use and
compositions covering the use of betahistine with olanzapine for the
mitigation of the serious weight gain associated as a side effect of the
antipsychotic drug.
“The commercial opportunity of adjunctive
Histalean® therapy, to enable”
Obecure is focused on development of Histalean® (high dose
betahistine) as adjunctive to antipsychotic drug therapy for improved
treatment of schizophrenia, bipolar disorder and major depression.
Obecure has recently announced the outcomes of randomized, placebo
controlled Phase 1b and pilot Phase 2 trials, showing that
co-administration of Histalean® with olanzapine (Zyprexa®),
safely and significantly reduced weight gain and somnolence, two of the
most serious side effects associated with this drug, as with most of the
second generation antipsychotics as a drug class, also including
risperidone (Risperdal®), quetiapine (Seroquel®)
and aripiprazole (Abilify®).
These antipsychotic drugs are widely used to relieve symptoms of serious
psychiatric diseases including schizophrenia, bipolar disease and major
depression with cumulative prevalence >5% and early onset in adolescence
and even childhood. However, in recent years there has been growing
concern of regulators and practitioners about these drugs’ induction of
weight gain. Recent publications suggest that olanzapine causes an
average weight gain of about 8 kg in just 12 weeks. This not only
reduces patients’ compliance, but also exposes them to metabolic
syndrome, diabetes and cardiovascular disorders; a concern which has
resulted in FDA’s issuance of black box warnings, and which has greatly
affected prescription decisions. Moreover, daytime sleepiness
(somnolence) induced by these drugs is seriously impacting patients
quality of life – prohibiting driving, hampering their ability to hold
jobs and/or continue with their education.
“The allowance of our leading US patents validate the novelty and
practicality of our approach and are serving as the initial milestone in
our evolving intellectual property” said Dr. Yaffa Beck, CEO of Obecure,
adding that “Olanzapine is considered the most effective of the first
line antipsychotic drugs, but is also known to cause substantial weight
gain. It is thus the first drug we focused on.” The patent portfolio
includes applications pending worldwide, covering methods and
compositions of betahistine for management of weight and somnolence that
are secondary side effects of most psychiatric drugs.