OBEcure to start Phase II trials after Christmas
Obesity treatments developer announces FDA nod for next trials of flagship drug in the U.S.
Obesity treatments developer OBEcure has received the green light from the United States Food and Drug Administration to commence Phase II tests of its flagship drug, OBE 101.
The company has contracted with 20 medical centers in the U.S. that study obesity, to recruit patients for the clinical trial.
OBEcure, which belongs to the Bio Light Israeli Life Sciences Investments (TASE: BOLT) corporation, says the Phase II trials will begin in January 2007. They don't want to start the tests during the Christmas and New Year holiday seasons, which are characterized by heavy eating and weight gain, which could distort the trial results.
This is in fact the first round of tests that OBEcure will be conducting in the U.S. OBE 101 had been exempted from the first phase of testing because it is not a new drug at all, merely a new application of an existing drug, developed for vertigo.
The trials are designed to test the efficacy of OBE 101 in fighting obesity, explained Dr Yaffa Beck, CEO of OBEcure.
In parallel, the startup is developing other products to control weight. Some will shortly be tested in Canada.
Two weeks ago, Bio Light admitted that the Stanford investment bank would not after all be helping OBEcure float in U.S. markets, for reasons of 'internal policy'. Bio Light says it is considering its options, and adds that the FDA nod for the Phase II clinical trials should be of assistance.
The market for obesity drugs, a hot-button issue these days, is estimated to be a billion dollars a year.