New Haven, CT, May 19, 2015 (GLOBE NEWSWIRE) -- Melinta Therapeutics today presented data that show the negative impact of obesity on patients' recovery from acute bacterial skin and skin structure infections (ABSSSI). A significant percentage of obese patients do not progress to full cure after antibiotic treatment is completed. Among obese patients whose infection was not fully cured at late follow-up, health-related quality of life (HRQL) was statistically significantly worse than for those who were cured, as measured by the Extremity Soft Tissue Infection (ESTI) score. The study, titled "Evaluation of Patient Reported Outcomes (PRO) in Obese Patients in an Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 3 Trial," was presented today at the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Philadelphia, PA.
"Obesity is associated with a number of increased health-related risks, including worse outcomes in skin infections such as cellulitis, increased risk of MRSA infections, higher rates of readmissions to the hospital and "bounce back" visits to the ER or physician's office for the same infection. This may be due in part to the challenges of antibiotic dosing as well as changes in physiology associated with obesity that may impact the performance of antibiotics," commented Dr. Sue Cammarata, Melinta's chief medical officer. "Given that 50% of the patients hospitalized with skin infections are obese, and also considering the threat of antibiotic resistance, it is crucial that treatment algorithms for obese patients with bacterial infections be optimized to ensure they reach a cure. Also, considering the high cost of hospitalization, we believe there is also a pharmacoeconomic argument to focus on therapies that deliver complete resolution of the signs of infection in obese patients."
A total of 214 obese patients were enrolled as part of 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. Of obese patients enrolled regardless of treatment, 193 obese (BMI>30) patients with a positive clinical response (cured or improved) were assessed for changes in lesion size, signs and symptoms, pain score, and patient-reported HRQL to understand the impact of obesity on their response to antibiotic treatment. 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.
At the end of treatment (EOT), the investigators assessed that 55% of these patients were improved and 26% were cured. The treating physician assumes that improved patients progress to a cured state without further antibiotics. However, at late follow-up, 26% of patients who were improved at EOT remained improved and had not progressed to a cure. These patients recorded a significantly higher ESTI score, indicating greater impairment, than did cured patients at late follow-up (46.4 vs 26.3, p=0.029). Performing a job and earning an income were more difficult due to the infection for these improved obese patients than for cured (29.0% vs 9.6%; and 32.3% vs 14.0%, respectively).
Further, obese patients who were improved at late follow-up showed less improvement in lesion size than did cured patients (79.7% vs 99.6%). Overall, they had a higher mean number of signs and symptoms than did cured obese patients at each assessment, showing a mean 1.8 vs 0 for cured patients at late follow-up. These patients also experienced more pain and required 1.4 days of additional treatment.
The International Society for Pharmacoeconomics and Outcomes Research is being held May 16-20, 2015 in Philadelphia, PA. After the conclusion of the meeting, Melinta will make the poster available for download on the company's website.
PROCEED is comprised of two Phase 3 studies, RX-3341-302 and RX-3341-303, the latter of which continues to enroll patients under the special protocol assessment (SPA) agreed to with the U.S. FDA.
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.