Bio-Light: FDA has given permission to file request to proceed directly to Phase 2 Clinical trials

Gil Shlomo, Globes, March 26

Obecure, a company held by the Bio-Light group and which is developing a drug for weight control, reported today that it has received permission from the FDA in the United States to immediately apply directly for permission for Phase 2 clinical trials, without having to go through the Phase 1 trials, which establish a drug's safety.

Next month Obecure will submit its FDA request to begin Phase 2 clinical trials. It is already in contact with medical centers in the U.S. to run the trials and recruit subjects. It is estimated that within three months of receiving approval, the company will be able to begin giving patients its drug. At the same time, the company reports that it has completed lab investigations requested by the FDA, before proceeding to Phase 2 trials, and the results of the tests have shown that the drug shows no danger of causing cancer or being toxic to those who take it.

Dr Ami Eyal, the company's CEO, said “We did not have any real doubts regarding the safety of our drug. We have invested a great deal of effort in shortening and making the regulatory procedures more efficient, and planning our trials in the quickest and most effective way, with the goal of finding the proper and optimal dosage of the pharmaceutical and measuring the effect that it has on body weight. Clearly, overweight is one of the most difficult health issues we face in the 21st century, and the need to bring a safe and effective drug to market to help deal with it is tremendous.” 

Hebrew ver.