Cellceutix Corp (OTCMKTS:CTIX) provided update on its one of the lead drug candidate ‘Brilacidin.’ The company is formulating ‘Brilacidin’ under a QIDP designation from the U.S. FDA as a potential unique and new treatment for ABSSSI. The team concluded 215-patient Phase 2b study of Brilacidin.
The two varied single dose treatments and a three-day treatment were shown to be comparably successful as the FDA accepted 7-day dosing treatment of the antibiotic daptomycin. In year 2014, daptomycin was sold under that brand Cubicin by Cubist Pharmaceuticals Inc (NASDAQ:CBST) and generated sales of $1.046 billion. Last December, Merck & Co., Inc. (NYSE:MRK) agreed to buy Cubist for almost $9.5 billion, including debt.
The data
Cellceutix stated that it reported the positive top-line results from the Phase 2b Brilacidin study in last October. After the initial submission of results from this trial to the U.S. FDA, the agency asked for the additional data from the study. The company has collected MIC findings from bacterial pathogens isolated in the study, PK data, performed PD modeling, and performed in-depth assessments of the safety profile of drug Brilacidin relative to ‘daptomycin’ in this patient population.
Cellceutix intends to meet with the U.S. FDA for an End-of-Phase II meeting in June 2015. Once the proposals are approved, the company will begin Phase 3 study of Brilacidin for ABSSSI.
The other target
Cellceutix also stated that it is performing a Phase 2 study of Brilacidin oral rinse for the attenuation or prevention of oral mucositis. It occurs in the mouth in the patients taking chemotherapy and radiation therapy for neck and head cancer. Almost 450,000 patients each year in the U.S. experience OM. In last trading session, the stock price of Cellceutix dropped more than 3% to close the trading session at $2.90. The decline came at a share volume of 190,608 compared to average share volume of 205,314.
