Beverly, MA — 10/14/13 — Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, is pleased to announce that the Company is completing the required documentation to begin a Phase 2b clinical trial of Brilacidin as a new drug candidate for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI.
Based upon what Cellceutix can only describe as exceptional results in a completed Phase 2a trial and building upon guidance from prior meetings regarding Brilacidin with the Division of Anti-Infective Products of the U.S. Food and Drug Administration, Cellceutix is planning to advance the clinical development of Brilacidin in a Phase 2b dose-optimization clinical trial. The trial will include a single-dose regimen as well as a three-day dosing regimen using Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staphylococcus aureus (including MRSA) and Streptococcus pyogenes. Cellceutix believes that, based upon consultation, the trial will begin in January 2014.
In September, the Centers for Disease Control and Prevention (“CDC”) released a report, entitled, “Antibiotic Resistance Threats in the United States, 2013.” Specifically, the report stated “Antimicrobial resistance is one of our most serious health threats” as part of an analysis of the “potentially catastrophic consequences of inaction” in a growing epidemic where resistance to current antibiotics is leaving few options that are generally less effective and more expensive. Cellceutix is diligently working to commence the Brilacidin Phase 2b trial as well as exploring accelerated approval programs available with the FDA to meeting this area of great unmet medical need.
“More than two million Americans acquire serious bacterial infections annually. The CDC has made it clear as to how critical it is to develop new therapies to address this fact, which has recently been highlighted by news of National Football League and NFL Players Association acknowledging a problem with MRSA infections.” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “Brilacidin is the first of an entirely new class of antibiotics, known as defensin-mimetics. It can rapidly kill the bacteria that cause ABBBSI, including resistant strains of Staph aureus, such as MRSA. Also, unlike most antibiotics, Brilacidin has minimal potential to promote the further development of resistant strains. This is because of its unique mechanism of action, as well as its ability to be given as a short course regimen, perhaps as a single dose. Both single and 3-day dosing regimens will be explored in the upcoming phase 2b study. Single-dose therapy removes patient non-adherence as a driver of antimicrobial resistance, and it allows for reduced health care costs, as patients do not need to return to the clinic or hospital for additional doses.”
Dr. Menon added, “Brilacidin could be the key antibiotic on the horizon for serious skin infections. Based on sales of antibiotic compounds and recent billion-dollar acquisitions that reflect the value of new antibiotics, we are very excited and believe that an FDA approved Brilacidin would capture a significant share of the ABSSSI market, due to its unique attributes, including short-course therapy. With ABSSSI as the lead indication, followed by other possible uses for infected wounds, bone, joint and blood stream infections, Brilacidin could fill a large void in the dwindling global portfolio of effective antibiotics. Our strategy includes capitalizing on the Generating Antibiotics Incentives Now (GAIN) Act, which, combined with other government efforts, is positively changing the regulatory climate in the developmental of drugs like Brilacidin.”