Melinta Therapeutics says it’s on track to file for an approval of its late-stage IV-to-oral antibiotic later this year after racking up positive results from a confirmatory Phase III study. And execs at the company say they are prepping for a commercial launch.
Top-line data for the Phase III study of delafloxacin (Baxdela) confirmed its noninferiority to IV vancomycin combination therapy with aztreonam for acute bacterial skin and skin structure infections (ABSSSI). The New Haven, CT-based biotech says that the study met both FDA and EMA guidelines in clearing the late-stage hurdle.
Melinta has spent 16 years and tens of millions of dollars to get to this point. Initially called Rib-X, the company has gone through a few CEOs, last bidding goodbye to Mary Szela last fall and moving R&D chief Eugene Sun to the helm. Back in 2014 the company punted a plan to develop delafloxacin in gonorrhea, switching focus to ABSSSIs.
The company is part of a group of biotech startups which saw some real potential in developing antibiotics after the exodus of Big Pharma players left a growing need for new antibiotics to take the place of existing products losing ground against MRSA and other superbug infections. Merck ($MRK) has made a reentry into the field, with its Cubist buyout, but quickly abandoned early-stage research efforts in the process.
Half of the patients in the latest Phase III study at Melinta were obese, providing a snapshot of the antibiotic’s efficacy against tough-to-treat patients with diabetes and other co-morbidities.
“These are encouraging results, especially given Baxdela’s full spectrum of coverage of Gram-positive and Gram-negative bacteria including MRSA, which is unique among quinolones,” said Dr. William O’Riordan, chief medical officer of eStudySite, in a statement. “In addition, it performed well in this study against infections in difficult-to-treat patients, such as obese and diabetic patients, an important achievement.”
- here's the release