PolyMedix, Inc., an emerging biotechnology company developing acute care products for infectious diseases and acute cardiovascular disorders based on biomimetics, has received a notice of no objection from Health Canada for the Company’s Clinical Trial Application (CTA) for its defensin mimetic antibiotic compound, PMX-30063.
This notice of no objection allows for the initiation of human clinical studies in Canada. PMX-30063 is the first defensin mimetic antibiotic compound cleared to enter human clinical trials for systemic use, representing an entirely new class of antibiotic drugs.
The first Phase I clinical trial will assess the safety of PMX-30063. The protocol for the study involves a dose-escalation study in healthy volunteers in which each subject will receive a single dose of PMX-30063. Upon successful completion of the first clinical study, PolyMedix plans to initiate a second clinical trial to mimic the expected clinical dosing regimen.
The second trial, also to be conducted in healthy volunteers, will involve repeat dosing of two intravenous infusions per day, for five to seven days. Following these clinical trials, additional clinical studies and regulatory submissions will be required to obtain regulatory approval from the FDA and other regulatory bodies before PMX-30063 could be commercially sold.
“The clearance of the CTA for PMX-30063 represents a major milestone for PolyMedix,” said Nicholas Landekic, CEO of PolyMedix. “This novel antibiotic compound represents a fundamental potential breakthrough in the world of infectious diseases. This is the first small molecule defensin mimetic to enter clinical development intended for the treatment of systemic infections, and the first and only such compound which is designed to directly address the growing problem of bacterial drug resistance. We are proud to be the first company to be developing this completely new type of antibiotic to address a major clinical need and market opportunity.”