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The Company is pursuing several Phase II clinical trials to confirm the therapeutic efficacy of Histalean™ in weight management and associated indications:
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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 were randomized into one of four groups treated for 12 weeks, as follows:
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Study drug - 8 mg twice a day (BID)
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Study drug -16 mg BID
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Study drug - 24 mg BID |
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Matching placebo - BID |
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In addition to receiving study medication, subjects were maintained on a nutritionally balanced mildly hypocaloric diet.
Primary Objective: Significant difference in weight loss between placebo to any of the treatment groups.
Status: Completed
Results
Barak et al. International Journal of Obesity (2008) 1-7
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BET207 - The Effect of HistaleanTM on Body Weight in Obese Pre-Menopause Women
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Histalean™ will be 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, 180 obese female subjects, aged 18-50, will be given diet guidance and randomized into one of three groups and treated for 12 weeks, as follows: |
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Study drug - 24 mg twice a day (BID) – total 48 mg/day
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Study drug - 48 mg BID – total 96 mg/day
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Matching placebo - BID
Status: Completed Enrollment
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BET202 - The Effect of Betahistine on Body Weight Gain Due to Olanzapine Treatment
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Histalean™ (24 mg BID for a total daily dose of 48 mg) or matching placebo was co-administered with olanzapine for 16 weeks in patients (male and female; aged 16-65) suffering from schizophrenia in this randomized, double-blind, placebo-controlled multicenter Phase II clinical study. An interim analysis conducted by an independent audit committee, after about half of the patients completed treatment, revealed no statistical differences in weight gain between the two study arms, and the study was discontinued.
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Study drug - 24 mg BID
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Matching placebo - BID
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Status: Terminated
Results: Data analysis is ongoing
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BET204 - Metabolic Effects of Betahistine in Obese Women
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IND approved |
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The NIH is conducting a study to establish whether using betahistine for increasing histaminergic tone in humans reduces food intake and affects satiation or satiety in obese women. Such findings, if sustained, would be expected to promote loss of adipose tissue, and thus improve the co-morbid conditions associated with obesity.
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The study consists of a 3-day in-patient double-blind, randomized placebo-controlled dose-ranging study of betahistine's effects on food intake and satiation/satiety in women.
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Hypotheses
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Safety: Betahistine, taken at doses of 16 mg, 32 mg, and 48 mg TID will be well tolerated by obese adults and will have a side effect profile similar to placebo. |
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Mechanism of Action - Energy Intake: The primary hypotheses being tested are that betahistine will decrease desire to eat, decrease actual food intake during meals, and increase the duration of satiety in a dose-dependent manner. Inpatient test meal studies with a standard food array will show that overall energy intake will be reduced by betahistine in a dose-dependent manner. Another exploratory hypothesis will examine if macronutrient selection is altered by betahistine. |
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Mechanism of Action - Energy Expenditure: Betahistine will increase resting energy expenditure as measured by indirect calorimetry.due to effects on sympathetic tone |
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Gut hormone assessment: Since we expect betahistine to have acute effects on appetite, food intake, and satiety, the NIH will determine if there are changes in relevant gut hormones such as ghrelin, glucagon-like-peptide 1 (GLP-2), PYY, and cholecystokinin (CCK) |
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Status: On-going |
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