New Drug Application Submitted to FDA for Iclaprim, Treatment for ABSSSI

A New Drug Application (NDA) has been submitted to the US Food and Drug Administration (FDA) for iclaprim, a targeted Gram-positive investigational antibiotic for the treatment of acute bacteria skin and skin structure infections (ABSSSI).

“The NDA submission for iclaprim is a major milestone for Motif Bio. Our team of experts has worked tirelessly to achieve this important goal,” Motif Bio’s chief executive officer, Graham Lumsden, said in a recent statement. “We look forward to working with the FDA with the goal of bringing this antibiotic candidate to patients as expeditiously as possible.”

Iclaprim works in a way that differs from most antibiotics on the market, according to Motif Bio, in that it is able to quickly kill bacteria in vitro. In an interview with Contagion^®, William O’Riordan, MD, FACEP, chief medical officer of eStudySite, shed light on what makes the antibiotic so distinctive.

“It has a very unique mechanism of action where, in the future—and we can’t say conclusively, but it will look very difficult because of its 2 mechanisms—for resistance to occur. I think that is a unique feature of this antibiotic,” he stressed. “It interferes with dihydrofolate reductase, which is intimately involved with the bacterial cell and the cell integrity and does away with the cell itself.”

Pooled analyses of 2 phase 3 trials—REVIVE-1 and REVIVE-2—have conclusively established the safety and effectiveness of iclaprim compared with vancomycin in the treatment of ABSSSI.

In the pooled analyses of 593 patients treated with iclaprim and 605 who were treated with vancomycin, investigators were able to confirm that iclaprim was noninferior during median treatment duration of 7 days for both drugs. Furthermore, they noted that in 79.6% of patients treated with iclaprim early clinical response was noted, whereas it was 78.8% for those treated with vancomycin.

Pooled safety data of 592 patients who were administered iclaprim and 599 who received vancomycin proved that iclaprim was well-tolerated. Furthermore, the number of treatment-associated adverse events for iclaprim were comparable to vancomycin in prevalence (49.2% vs 43.6%), and the same held true for serious adverse events (4.2% vs 4.7%). None of the patients who received iclaprim died.

Previous to this, iclaprim received Qualified Infectious Disease Product (QIDP) designation and Fast Track Designation from the FDA. If the NDA is accepted, the antibiotic will receive Priority Review, with a review period of just 6 months compared with the normal 10 months.