– Conclusions Based on Results from Phase 3 Trial of Delafloxacin in Patients with Acute Bacterial Skin and Skin Structure Infections –
NEW HAVEN, Conn — April 9, 2015 — Melinta Therapeutics today presented an evaluation of Health-Related Quality-of-Life (HRQL) in acute bacterial skin and skin structure infection (ABSSSI) patients who have been cured (a complete resolution of all baseline signs and symptoms) versus improved (no further antibiotics are deemed necessary even though some symptoms remain) after antibiotic therapy. The poster, which was unveiled at the annual Academy of Managed Care Pharmacy meeting, showed that cured patients had lower pain scores and fewer difficulties with HRQL measures than did improved patients at follow-up. At late follow-up (study day 21-28), approximately 20% of the patients who were improved at end of treatment when antibiotics were stopped still had not progressed to full cure. Those patients who had not progressed from improved were significantly more likely than cured patients to report a continued difficulty performing a job and earning an income.
“Healthcare providers are under increased scrutiny from government authorities and the public to lower re-admission rates and improve patient satisfaction scores,” stated Dr. Sue Cammarata, Melinta’s chief medical officer. “Historically, however, there has been limited data on the extent to which the clinical response (improved or cured) impacts a patient’s HRQL or their utilization of additional healthcare resources. By conducting this analysis, Melinta aims to provide physicians with data that inform their assumptions about a patient’s improvement after antibiotics are stopped.”
Analysis was performed on 589 patients who had a positive clinical response during the first of two Phase 3 PROCEED studies (RX-3341-302, NCT01811732), which evaluated delafloxacin, an investigational fluoroquinolone, compared with vancomycin + aztreonam for the treatment of patients with ABSSSI. The analysis was conducted on patients regardless of treatment assignment. At late follow-up, patients completed the Extremity Soft Tissue Infection (ESTI) Score, which measures the degree of importance/impairment as assessed by patients of their symptoms, daily functioning, emotional functioning, and social interactions. In this study, 27.8% of patients whose condition was improved at late follow-up, versus 8.8% of cured patients, reported a continued difficulty performing a job (p<0.0001); and 29.1% of improved patients at late follow-up versus 10.8% of cured patients report a continued difficulty earning an income (p=0.0001).
Dr. Cammarata continued, “The persistent HRQL issues and continuing signs and symptoms of infection experienced by patients who do not progress to full cure after the end of antibiotic treatment may require further utilization of health care resources to see full resolution of signs and symptoms, and may results in lower patient satisfaction ratings. Additional research is needed to determine the potential economic impact of these data.”
The Academy of Managed Care Pharmacy Annual Meeting & Expo is taking place April 7-10, 2015 in San Diego, CA. More information on the meeting may be found at www.amcpmeetings.org. Melinta’s poster, titled “Evaluation of Signs and Symptoms and Health Related Quality of Life in Cured vs. Improved Patients in an Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 3 Trial” will be available at the meeting from April 9-10; and thereafter will be available for download from the Melinta website.
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. 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.
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.