PolyMedix, Inc., a biotechnology company dedicated to developing novel treatments for infectious diseases with defensin-mimetic antimicrobial agents, recently had a Type B meeting with the Division of Anti-Infective Products of the United States Food and Drug Administration (FDA). As a result of the meeting, PolyMedix has direction with respect to the design and conduct of its planned phase IIB dose-optimization clinical trial using brilacidin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus (including MRSA) and Streptococcus pyogenes.
"We are pleased with the outcome of our meeting with the FDA, and appreciate the Division's assistance and guidance, "commented Dr Daniel Jorgensen, Senior Vice President of Clinical Development and Chief Medical Officer at PolyMedix. "As a result of this meeting, we are encouraged by our planned path to advance the clinical development of brilacidin, including use of single-dose and three-day dosing regimens, in a phase IIB dose-optimization clinical trial."
In advance of the meeting, PolyMedix provided the FDA with the phase II B clinical trial plans for brilacidin. PolyMedix received support for its proposed regimens of one and three day dosing, as well as guidance to enhance the proposed phase II B protocol. Subject to the availability of adequate cash resources, PolyMedix plans to initiate the phase II B dose-optimization study in early 2013.