Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, announced positive top-line results from its Phase III trial of Baxdela® (SBECD enabled delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP).
Baxdela was compared to moxifloxacin in this randomized global trial. Baxdela met all key primary and secondary endpoints in the trial, including the study’s primary U.S. Food and Drug Administration (FDA) endpoint showing Early Clinical Response (ECR) with improvement at 96 hours (± 24 hours) after the first dose in at least two of the following symptoms: chest pain, frequency or severity of cough, amount of productive sputum, and difficulty breathing.
Baxdela was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. The Menarini Group, Melinta’s commercial and co-development partner, submitted a Marketing Authorization Application (MAA) to the EMA in March 2018 for delafloxacin (to be marketed under the trade name Quofenix in Europe) for the treatment of adult patients with ABSSSI.
Melinta anticipates filing a sNDA with the FDA for Baxdela for the treatment of adult patients with CABP (Community-Acquired Bacterial Pneumonia) in the first half of 2019. The FDA has designated Baxdela as a Qualified Infectious Disease Product (QIDP) for CABP, and therefore the sNDA for CABP is eligible for FDA priority review.