Danish pharmaceutical company NeuroSearch reported on Sept. 17th that its drug tesofensine enabled overweight patients to lose an amazing average of more than 28 pounds in a 24-week Phase II clinical trial.
Neurosearch, which accidentally discovered that tesofensine promoted weight loss during studies of the drug for treatment of Alzheimer's Disease and Parkinson's Disease, said it now expects to start Phase III trials for tesofensine during the first part of next year.
Tesofensine is a triple monoamine re-uptake inhibitor which blocks the re-uptake
of the neurotransmitters serotonin, dopamine and nor-adrenaline in the brain
with no direct effect on the monoamine receptors.
Tesofensine’s impact on the three monoamine systems is believed to induce weight reduction through both a reduction in appetite and an effect in the metabolic center in the brain leading to an increased metabolic rate that helps the body burn fat.
Neurosearch said that in its trial, 204 patients who weighed on average between 220 and 230 were divided into four groups who either received a placebo, a .25 mg dose of tesofensine, a .5 mg dose or a 1 mg dose.
While those in the placebo group lost an average of just under 5 pounds, those taking a .25 mg dose of tesofensine lost an average of almost 15 pounds, those taking a .5 mg dose lost an average of almost 25 pounds, and those taking a 1 mg dose lost an average of more than 28 pounds.
"In the two highest dose groups (0.5 mg and 1.0 mg), treatment with tesofensine
led to an average reduction in the patients’ BMI of 4," the company reported.
Neurosearch said one-fifth of the patients dropped out during the study, with the highest numbers discontinuing either in the placebo group or the group receiving the highest dose.
"The most frequently reported adverse events were mostly mild to moderate, and
included dry mouth, sleep disturbances, nausea, constipation and diarrhea," the company reported. "No clinically relevant cardiovascular adverse events or changes in either blood pressure or pulse were seen, according to FDA criteria."
Dr. Arne Astrup of the University of Copenhagen, who led the study of tesofensine, said he was "thrilled" to see the tesofensine trial produce a weight-loss of approximately 22 pounds more than placebo without major safety concerns.
"If tesofensine will prove to live up to this weight loss effect in 12 months’ Phase III trials, thereby opening a whole new dimension in obesity management that can effectively compete with gastric surgery, this drug will definitely set a new standard in obesity treatment," Astrup said.