Negative impact of obesity on patients treated with captisol-enabled delafloxacin in treatment of ABSSSI- Melinta Therapeutics

Melinta Therapeutics 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 III Trial,” was presented today at the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Philadelphia, PA.

A total of 214 obese patients were enrolled as part of the first of two Phase III 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.