Motif Bio submits new drug application to U.S. FDA

recently, antibioticsnew drug(Research andCompany(Bio) announced that it has submitted a new drug application (NDA) to the U.SFDA (NDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI)about the iclapon
iclaprim is a new antibiotic that has broad-spectrum antibacterial effects on a wide range of Gram-positive bacteria, including Staphylococcus aureus's powerful antibacterial effect makes it less effective than vancomycin and other commonly used antibioticsIn addition, its effect on the kidneys is also less than vancomycinIclaprim has obtained the Qualified Infectious DiseasesProduct(QIDP) and Fast Track Accreditation from the FDAAfter the FDA accepts the NDA application, iclaprim will receive a six-month priority review instead of the standard ten monthsrelated studies
this NDA application is based on two Phase 3 clinicaltrial (positive results, studies show that iclapper can be effective in treating ABSSSI patients.) In the Revive-1 study, iclaprim reached a major non-adverse end point (ETP) 48-72 hours after initial administration, compared to the current standard antibiotic therapy, vancomycin analyzed of pre-designated secondary endpoints
in Revive-1 (showed that 60.4 percent of patients receiving iclaprim showed that inflammation subsided or nearly subsided at the end of treatment, compared with 58.3 percent of patients receiving vancomycin.) In the Revive-2 study, iclaprim also reached the primary endpoint of non-performance compared to vancomycin data show edgym showed a clinical cure rate of 78 percent among patients, slightly higher than those taking vancomycin Within 48-72 hours of administration, the area of lesions decreased by more than 20% According to Motif's trial data, 54.6 percent of patients treated with iclaprim had their inflammation subside or nearly subside at the end of treatment (EOT), compared with 55.4 percent of patients treated with vancomycin