Cellceutix Corp (OTCMKTS:CTIX) reported that the U.S. FDA has allowed the company to advance with Brilacidin Phase III study for the cure of ‘Acute Bacterial Skin and Skin Structure Infections.’ The company stated that in the recent meeting conducted after the end of Phase II, the FDA and management discussed efficacy and safety data of Phase II. After evaluation of data, and considering the basic elements of planned Phase III study, the FDA approved to commence Brilacidin Phase III Study in ABSSSI.
The Phase III study would be conducted in two parts, as required by the FDA. Cellceutix reported that the first trial would focus on an interim analysis after some subjects has been enrolled. It would result in an early evaluation of both efficacy and safety. As part of the deal, the company needs to provide a Pediatric Study Plan within sixty days from the end date of Phase 2 Meeting.
The expert speaks
Dr. Daniel Jorgensen, the Chief Medical Officer of Cellceutix Corp (OTCMKTS:CTIX), is delighted with the result of the meeting. He said that it was a collaborative meet, and the U.S. FDA was exceedingly helpful in offering guidance on company’s clinical development plan in ABSSSI. The first part of an interim analysis is important as the drug under development is a new class of antibiotics.
Brilacidin, the drug under focus, is the main compound in a new category of antibiotics termed as the “defensin-mimetics.” These compounds have an ability of mimicking the host defense proteins of the natural immune system. Due to this ability, they have both immunomodulatory and antibacterial properties. The drug has been dosed intravenously in more than 400 enrollments in Phase I and Phase II study.
In last trading session, the stock price of Cellceutix declined more than 4% to close the trading session at $2.78. The decline came at a share volume of 266,468 compared to average share volume of 284,396.