High hopes for Cellceutix’ Brilacidin for serious skin infections

US clinical-stage biopharmaceutical company Cellceutix (OTCQB: CTIX) says that it is completing the required documentation to begin a Phase IIb clinical trial of Brilacidin (formerly PMX-30063) as a new drug candidate for acute bacterial skin and Skin structure infections (ABSSSI).

Brilacidin came under the control of Cellceutix last month with the firm’s acquisition of assets belonging to PolyMedix from the bankruptcy court (The Pharma Letter September 9).

Based upon what Cellceutix says it can only describe as “exceptional results” in a completed Phase IIa trial and building on guidance from prior meetings regarding Brilacidin with the Division of Anti-Infective Products of the US Food and Drug Administration, Cellceutix is planning to advance the clinical development of Brilacidin in a Phase IIb 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 ABSSSI caused by Staphylococcus aureus (including MRSA) and Streptococcus pyogenes. Cellceutix believes that, based on consultation, the trial will begin in January 2014.