Cellceutix Compares Brilacidin To Cubicin In Phase IIb Trial For ABSSSI
By Cyndi Root
Cellceutix Corporation announced in a press release that it has completed enrollment for a Phase IIb trial comparing Brilacidin to Cubicin (daptomycin) for acute bacterial skin and skin structure infections (ABSSSI). In the fourth quarter of 2014, the company expects data from the trial. Brilacidin shows promise as a single-dose antibiotic with a low potential for antibiotic resistance.
Leo Ehrlich, CEO of Cellceutix, said, “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.”
Brilacidin
Brilacidin is an antibiotic known as a defensin-mimetic. These compounds are potent antibiotics that kill Staph aureus, including methicillin-resistant Staph aureus (MRSA). Its mechanism of action delays, limits, or stops the development of antibiotic resistance — increasing concern to health officials worldwide. Additionally, the agent has possibilities for administration as a single-dose.
Cellceutix states that 215 patients are enrolled and are randomized in four groups – a single dose of Brilacidin 0.6mg/kg, a single-dose of Brilacidin 0.8mg/kg, a 1.2mg/kg dose of Brilacidin over 3 days, or seven days of once-daily Cubicin (daptomycin).
Brilacidin Competition
The Food and Drug Administration (FDA) recently gave guidance to industry on developing treatments for acute bacterial skin and skin structure infections, indicating its interest in developing new drugs. In May 2014, the federal agency approved Dalvance (dalbavancin), an IV antibiotic. The FDA had given the drug Priority Review as a Qualified Infectious Disease Product (QIDP) and the FDA’s Anti-Infective Drugs Advisory Committee recommended it in a 12-0 vote.
The FDA also approved Sivextro (tedizolid) in June of 2014. Sivextro received expedited review and QIDP status, receiving an additional five years of marketing exclusivity. Even more recently, Orbactiv got an FDA nod of approval in August 2014 with QIDP designation, as it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection.
About Cellceutix
Cellceutix is headquartered in Beverly, Massachusetts. A publically traded company, Cellceutix focuses on oncology, dermatology, and antibiotic applications. Currently in a Phase I clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, Cellceutix’s anti-cancer drug Kevetrin activates p53, which plays a crucial role in controlling cell mutations.