Phytopharm, a developer of botanical pharmaceuticals, announced this week the successful completion of the third and final stage of a study to evaluate a product under development as an appetite suppressant for the treatment of obesity and related conditions.
The objectives of the study included the evaluation of the safety, tolerability, pharmacokinetic profile and effect on calorie intake of P57.
This stage of the study used a double-blind, randomised, placebo-controlled design. Nineteen overweight but otherwise healthy male volunteers were randomly allocated to receive either P57 or placebo twice daily for 15 days.
Eighteen subjects completed the study (nine subjects in each of the P57 and placebo groups). Assessments recorded during the study included daily calorie intake, body weight and body fat content. The primary endpoint compared the average daily calorie intake between the groups for the last three days of dosing. Blood samples were also obtained for routine analysis of safety parameters and pharmacokinetic profiling of this orally administered agent.
Preliminary data indicate that there was a statistically significant reduction in the average daily calorie intake of the P57 group compared with the placebo group (p= 0.014). Preliminary data also indicate a statistically significant reduction in body fat content in the P57 group compared with the placebo group at the completion of dosing (p=0.035).
No serious adverse effects were experienced by any of the subjects, and the safety data are consistent with a satisfactory overall safety profile. The pharmacokinetic data confirm that the systemic exposure to biologically active constituents of P57 was consistent with the observed clinical effects.
According to the World Heath Organisation (WHO), obesity accounts for tens of billions of pounds in direct healthcare costs worldwide. A panel of experts convened by WHO stated on 12 June 1997 that 'obesity's impact is so diverse and extreme that it should now be regarded as one of the greatest neglected public health problems of our time. It has an impact on health, which may well prove to be as great as that of smoking' (World Health Organisation, 1997).
Dr Richard Dixey, Chief Executive of Phytopharm, said: "This study demonstrates proof of principle for P57. The data are very encouraging and provide a foundation for the substantial body of work that now needs to be done to carry the project forward to commercialisation.''