ContraFect Corp (NASDAQ:CFRX) said Monday that it plans to advance its exebacase treatment of bacterial infections including endocarditis to a Phase 3 clinical trial, citing positive topline results from Phase 2.
Yonkers, New York-based ContraFect said in a press release that exebacase demonstrated great potential as well as robust safety and tolerability in what is described as the first Phase 2 study involving patients treated with lysin therapy complementary to conventional antibiotics.
“We are very pleased with the strong efficacy signals and the encouraging safety and tolerability profile of our lead first-in-class therapeutic product candidate in this study, which establishes the potential for exebacase to substantially improve the clinical responder rates for serious antibiotic-resistant infections seen with antibiotics alone,” Chairman and CEO Steven C. Gilman, Ph.D., said in a statement. "These data support progression to Phase 3.”
The company said that exebacase, used in addition to standard-of-care antibiotics, achieved a 70.4% responder rate, compared with 60% among patients treated with antibiotics alone.
ContraFect said the results represent a positive signal of efficacy, particularly given the heterogeneous patient population and an unexpected imbalance in the distribution of hard-to-treat left-sided endocarditis in favor of the placebo group.
Shares of ContraFect declined $1.07, or 55%, to $0.95 in Monday’s Nasdaq trading.
Endocarditis is an infection of the endocardium, which is the inner lining of heart chambers and heart valves.
Contact Dennis Fitzgerald at [email protected]