NEW HAVEN, Conn – January 7, 2015 – Melinta Therapeutics today announced positive top-line results from the first of two Phase 3 PROCEED studies (study RX-3341-302, NCT01811732) to evaluate delafloxacin, an investigational fluoroquinolone, compared with vancomycin + aztreonam for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Delafloxacin met the study’s primary objective endpoint of a reduction in the measurement of lesion erythema at the primary infection site at 48-to-72 hours, the endpoint required by the U.S. Food and Drug Administration. Delafloxacin also was comparable to vancomycin in the study’s secondary endpoints, including investigator assessment of signs and symptoms of infection at the follow-up visit, a metric required by the European Medicines Agency (EMA). In this study, delafloxacin was shown to be well tolerated among study participants. Mild gastrointestinal symptoms were the most treatment-related adverse events reported for delafloxacin, and rarely led to study discontinuation. Melinta expects to make complete results from this study available as a presentation at an upcoming medical meeting and a publication in a peer-reviewed medical journal.
Mary Szela, Melinta’s president and chief executive officer, added, “These top-line Phase 3 results are consistent with our experience with delafloxacin in Phase 2 clinical trials and are very encouraging, especially in certain patient subgroups whose infections can be challenging to treat. The completion of the first PROCEED study is a significant step in our effort to bring delafloxacin to market, where we believe it will provide physicians with an important new option in the treatment of serious, often life-threatening infections.”
Enrollment continues in the second confirmatory Phase 3 PROCEED study (study RX-3341-303 NCT01984684) in patients with ABSSSI. Melinta anticipates that top-line results from study 303 will be available in the second half of 2015. The two studies are designed to support a U.S. FDA New Drug Application (NDA).
About the PROCEED Studies
The PROCEED studies for ABSSSI (studies 302 and 303) are Phase 3, multicenter, randomized, double-blind, active-controlled studies to evaluate delafloxacin compared with vancomycin + aztreonam for the treatment of patients with ABSSSI. The studies’ primary endpoints are change in the area measurements of lesion erythema at the primary infection site at 48 to 72 hours. Secondary measures included the objective response using reduction of erythema of ≥30% at 48-to-72 hours; and investigator-assessed response of signs and symptoms of infection at the day-28 follow-up visit in the overall study population.
Delafloxacin, is an investigational fluoroquinolone antibiotic currently in Phase 3 clinical development for acute bacterial skin and skin structure infections (ABSSSI). The PROCEED studies (studies 302 and 303) are Phase 3, multicenter, randomized, double-blind, active-controlled trials to evaluate delafloxacin compared with vancomycin + aztreonam for the treatment of patients with acute bacterial skin and skin structure infections.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is dedicated to the discovery, development and commercialization of groundbreaking antibiotics to overcome drug-resistant, life-threatening infections. The need for new therapies for drug-resistant infections is widely recognized as one of the most serious public health issues facing the world today. To meet this need, Melinta Therapeutics is rapidly progressing its late-stage investigational antibiotic, delafloxacin, which is currently in Phase 3 development for acute bacterial skin and skin structure infections (ABSSSI). Delafloxacin has been designated a qualified infectious disease product (QIDP) for both ABSSSI and community-acquired bacterial pneumonia by the U.S. Food and Drug Administration. A key initiative at Melinta is to develop, through the application of Nobel Prize-winning science, a new class of antibiotics designed to overcome the drug-resistant ESKAPE pathogens known to cause serious hospital infections. Melinta Therapeutics is privately held and backed by lead investor Vatera Healthcare Partners among other private investors. The company is headquartered in New Haven, CT with offices in Lincolnshire, IL. Visit www.melinta.com for more information.