US regulators have accepted for review a targeted, Gram-positive investigational antibiotic developed by UK biopharma Motif Bio for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
In clinical trials, iclaprim showed non-inferiority (10 percent margin) to current standard of care vancomycin, 48 to 72 hours after the start of administration. The drug also achieved non-inferiority at the test of cure endpoint, seven to 14 days after treatment was discontinued, the firm noted.
More than 3.6 million people with ABSSSI are hospitalised annually in the US, but up to 26 percent have renal impairment, which, as well as obesity or diabetes, leaves patients more vulnerable to vancomycin-associated kidney injury, highlighting the need for new treatment options.
The US Food and Drug Administration has granted the marketing application for iclaprim a priority review, with a decision expected by February 13 next year.
The drug has been awarded a Qualified Infectious Disease Product (QIDP) designation by the FDA, which means that if it makes it to market it will be eligible for 10 years of market exclusivity.