Contrafect Corp. a 5-year-old biotechnology company based in Yonkers, is ready to begin clinical trials of its first infection-fighting drug product with humans.
Robert Nowinski, co-founder and CEO of Contrafect, told shareholders that the company has submitted to the U.S. Food and Drug Administration (FDA) its investigational new drug application (IND) for CF-301, a new therapy to treat staphylococcal bloodstream infections.
Drug-resistant staphylococcus, or MRSA, is one of the most serious bacterial infections afflicting hospital patients.
A recombinant protein, CF-301 was licensed by Contrafect from The Rockefeller University in Manhattan. Nowinski said the company over the last year performed required manufacturing, safety and efficacy testing in animals in both Contrafect’s laboratories at 28 Wells Ave. and with third-party contract organizations.
The drug has been successfully tested on hundreds of staph strains, including both conventional and drug-resistant varieties, he said. CF-301 will be clinically tested on humans as a therapy used in combination with the two antibiotics currently approved for treatment of MRSA.
Following an FDA review of its IND application, Contrafect will begin Phase 1 clinical trials with 80 healthy volunteers, said Nowinski. Phase 2 trials will be conducted at 45 sites in the U.S., where CF-301 will be given to 125 patients with staph bloodstream infections.
Nowinski said pivotal Phase 3 trials to determine the drug’s effectiveness at the intended dose will be carried out with 200 patients at 90 sites worldwide.
Following the three-phase trials, Contrafect expects to seek marketing approval from the FDA.
Launched in Manhattan, Contrafect in 2011 opened its downtown Yonkers headquarters in the i.park Hudson office and manufacturing complex.