PolyMedix Receives Regulatory Clearance to Initiate Second Phase I Clinical Study of Systemic Antibiotic Compound
News May 26, 2009
PolyMedix, Inc. 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 the second human clinical study in Canada.
PMX-30063 is a defensin mimetic antibiotic compound, the first of an entirely new class of antibiotic drugs that is believed to work in such a way that makes bacterial resistance unlikely to develop.
This second Phase I clinical trial will assess the safety of PMX-30063 given repeatedly over a period of several days. Healthy volunteers will each receive a dose of PMX-30063 every 12, 24, or 48 hours for a total of 5 to 10 doses. The previous study provided information on the time course of the drug in humans after single doses, indicating that regular once-daily dosing would provide sufficient drug levels for treating the infections to be targeted.
This study is planned to confirm those expectations, and comparison with doses given every 12 or 48 hours will provide valuable data on how the drug might be used most effectively against target bacteria.
Provided that we successfully complete this second clinical study, and provided that additional financing has been obtained, PolyMedix plans to request regulatory permission to test the drug on actual infections in hospitalized patients, in Phase II clinical studies.