Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, has announced the completion of enrollment in its phase 2b trial comparing Brilacidin to daptomycin (Cubicin) in patients with acute bacterial skin and skin structure infections (ABSSSI). Overall, 215 patients were randomized to one of three dosing regimens of Brilacidin (single dose 0.6mg/kg; single-dose 0.8mg/kg; 1.2mg/kg over 3 days) or 7 days of once daily daptomycin.
Brilacidin is the lead compound among a novel class of antibiotics known as defensin-mimetics. These compounds have shown great promise in preclinical and early clinical studies as potent antibiotics that can kill Staph aureus, including methicillin-resistant Staph aureus (MRSA). Moreover, given the unique mechanism of action, among other attributes, there is low, if any, potential for the development of resistance. Finally, the results of the current study may demonstrate that Brilacidin could be given as a single-dose, which provides benefits for both patients and society.
This combination of properties makes Brilacidin unique among antibiotics recently approved or in development for the treatment of MRSA. Because these other compounds come from existing classes of antibiotics, there is the potential for cross-resistance; this is not the case for Brilacidin.
“This is an important milestone for Cellceutix and for the field of infectious diseases” said Leo Ehrlich, the company’s chief executive officer, ”There is no other antibiotic with these properties, which can treat infection and potentially decrease the burden of antibiotic resistance. Resistance, the antibiotic slayer. We are now in the process of manufacturing 30 kg of Brilacidin for future clinical trials which we plan for multiple forms of serious infections.”The company expects data from the trial to be available in the fourth quarter of 2014.