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The Company has completed several Phase II clinical trials to confirm the therapeutic efficacy of Histalean® as follows: |
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Obesity Trials:
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BET201 - The Effect of Histalean® on Body Weight in Obese Subjects
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Histalean®was evaluated in a randomized, double-blind, placebo-controlled, dose-finding, multicenter Phase II clinical study. Subsequent to screening and a two week placebo run-in period, 281 obese subjects, observing a mildly hypo-caloric diet, were randomized to be treated for 12 weeks with betahistine doses of 16 mg, 32 mg, or 48 mg. or with matching placebo.
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Status: Completed
Results:
Safety: Betahistine was well tolerated and safe at all dose levels.
Efficacy: Although there was a slight trend favoring betahistine versus placebo in analyses of mean weight loss in the ITT population, this was neither dose dependent nor statistically significant. Post hoc analyses suggested the importance of gender and age in betahistine response, achieving a statistically significant difference favoring 48 mg/day dose betahistine over placebo in female subjects >50 years of age.
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BET207 - The Effect of Histalean® on Body Weight in Obese Pre-Menopause Women
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A randomized, double-blind, placebo-controlled, dose-finding, multicenter Phase II clinical study was conducted to evaluate the efficacy of betahistine in premenopausal women on a mildly hypocaloric diet. Subsequent to screening, 180 obese female subjects were randomized and treated for 12 weeks, with betahistine 48 mg/day or 96 mg/day or matching placebo. |
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Status: Completed
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Results:
Safety: Betahistine was well tolerated and safe at all dose levels.
Efficacy: There was a slight trend favoring betahistine versus placebo in overall reduction of weight and somnolence; however this was neither dose dependence nor statistically significant. Post hoc analyses of the subpopulation of subjects with abnormal baseline somnolence levels (ESS>7) suggest that betahistine treatment results in a statistically significant improvement in somnolence.
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BET204 - Evaluation of Metabolic Effects of Histalean® in Obese Women
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Study sponsored by the NIH to assess the acute effect of betahistine on food intake, satiation or satiety in overweight and obese women. |
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The study was designed as a double-blind, randomized placebo-controlled single day dose-ranging (up to 48 mg TID) in subjects interned and monitored for 3 days.
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Status: Accrual completed; awaiting data from NIH. |
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Mitigation of Olanzapine-associated side effects - Weight gain and somnolence: |
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BET202 - The Effect of Histalean® on Body Weight Gain Due to Olanzapine Treatment
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A randomized, double-blind, placebo-controlled, multicenter pilot Phase II clinical study conducted to evaluate the feasibility of using 48 mg/day betahistine (24 mg BID) as adjunctive to olanzapine in previously minimally-exposed schizophrenia patients to mitigate the antipsychotic drug-associated weight gain over 16 weeks. |
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Status: Terminated after treatment of 36 patients (of the planned 70)
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Results:
Safety: Adjunctive betahistine was well tolerated and safe in olanzapine-treated patients. Moreover, it did not interfere with the olanzapine-derived improvement in psychiatric status, as evaluated by the Cognitive Global Scale (CGI) and the Positive and Negative Syndrome Score (PANSS).
Efficacy: A trend suggesting the benefit of using betahistine treatment in reducing olanzapine-associated weight gain. Moreover, subjects treated with olanzapine and betahistine showed improved psychiatric CGI and PANSS, as compared to subjects on olanzapine and placebo. However, neither effect achieved statistical significance.
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BET209 - Safety, pharmacokinetics and potentially beneficial drug-drug interactions effect of combined administration of Olanzapine with Histalean®.
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A randomized, double-blind, placebo-controlled, single center Phase I Proof-of-Concept clinical study conducted to evaluate the safety and potential benefit of 144 mg/day betahistine (48 mg TID) as adjunctive to olanzapine (7.5 - 10 mg/day) in 48 healthy women.
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Status: Completed
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Results:
Safety: Betahistine was well tolerated and safe at the high dose of144 mg/day (three times the currently approved maximum dose), as monotherapy and as adjunctive to olanzapine.
Efficacy: Study acheived clinically and statistically significant outcomes, as follows:
1. Patients treated with betahistine with olanzapine gained 40% less weight than their counterparts on placebo with olanzapine (p<0.05); there was also a lower frequency of subjects posting a weight gain >2 kg in the betahistine group versus placebo (23% versus 52%, respectively: (p<0.05)
2. Patients treated with betahistine with olanzapine were 60% less somnolent than their counterparts on placebo with olanzapine (p<0.05)
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