LONDON ¿ Botanicals specialist Phytopharm plc said it achieved a 35 percent cut in calorie intake in a Phase II proof-of-principle study with its obesity treatment, P57, and said it is in discussions with the licensee, Pfizer Inc., on how to carry development forward.
Eighteen obese but otherwise healthy males took part in the 15-day residential study, receiving P57 or placebo twice daily. Patients had individual two-hour periods in which to eat breakfast, lunch and dinner, and could eat as much as they liked. 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 two groups for the last three days of dosing. There was a significant reduction in the average daily calorie intake of the P57 group compared to the placebo group (p=0.014).
Richard Dixey, Phytopharm¿s CEO, told BioWorld International, ¿We are very pleased. This was an extremely demanding study. It is very difficult to get appetite suppression to work when all [the subjects] have to do is watch TV and eat.
¿There was a sustained and substantial reduction in calorie intake,¿ he added. ¿And whereas the control group put on 1 kilo on average, the treated group lost 1 kilo.¿
Dixey said P57, derived from a South African cactus, represents a new class of drug, calling it ¿the first orally bioavailable appetite suppressant that has a direct effect on satiety.¿
This is unlike amphetamines, which affect other areas of the brain and have a referred effect on satiety, he said. Furthermore, animal studies show that P57 can reduce calorie intake for long periods with no buildup of tolerance.
Phytopharm, based in Godmanchester, has now fulfilled the requirements of its research and development collaboration with Pfizer.
¿We are now discussing what to do next, but I can¿t say when any agreement will be finalized,¿ Dixey said. Pfizer, of New York, agreed to an exclusive license in August 1998.
Phytopharm also announced it is reviewing its work in alopecia after getting inconclusive results for P45 in a second Phase II trial for the treatment of alopecia areata and alopecia totalis, both of which are autoimmune forms of the disease. Last year the product failed in a Phase II study in male pattern baldness, alopecia androgenica.
The company¿s share price rose by 27 percent to #5.45 (US$7.81) after it announced the trial results last week.