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Melinta’s phase III trial shows significant burden of obesity on patients’ recovery from ABSSSI

Melinta Therapeutics presented data that show the negativeimpact of obesity on patients' recovery from acute bacterial skinand skin structure infections (ABSSSI).

A significant percentage ofobese patients do not progress to full cure after antibiotictreatment is completed. Among obese patients whose infection wasnot fully cured at late follow-up, health-related quality of life(HRQL) was statistically significantly worse than for those whowere cured, as measured by the Extremity Soft Tissue Infection(ESTI) score.

The study, titled "Evaluation of Patient ReportedOutcomes (PRO) in Obese Patients in an Acute Bacterial Skin andSkin Structure Infections (ABSSSI) Phase 3 Trial," was presentedtoday at the annualmeeting of the International Society for Pharmacoeconomics andOutcomes Research (ISPOR) in Philadelphia, PA.

"Obesity is associated with a number of increased health-relatedrisks, including worse outcomes in skin infections such ascellulitis, increased risk of MRSA infections, higher rates ofreadmissions to the hospital and "bounce back" visits to the ER orphysician’s office for the same infection. This may be due in partto the challenges of antibiotic dosing as well as changes inphysiology associated with obesity that may impact the performanceof antibiotics," commented Dr. Sue Cammarata,Melinta’s chief medical officer.

"Given that 50% of the patientshospitalized with skin infections are obese, and also consideringthe threat of antibiotic resistance, it is crucial that treatmentalgorithms for obese patients with bacterial infections beoptimized to ensure they reach a cure. Also, considering the highcost of hospitalization, we believe there is also apharmacoeconomic argument to focus on therapies that delivercomplete resolution of the signs of infection in obesepatients."

A total of 214 obese patients were enrolled as part of the firstof two Phase 3 PROCEED studies (RX-3341-302, NCT01811732), whichevaluated delafloxacin, aninvestigational fluoroquinolone, compared with vancomycin +aztreonam for the treatment of patients with ABSSSI.

Of obesepatients enrolled regardless of treatment, 193 obese (BMI>30)patients with a positive clinical response (cured or improved) wereassessed for changes in lesion size, signs and symptoms, painscore, and patient-reported HRQL to understand the impact ofobesity on their response to antibiotic treatment. At latefollow-up, patients completed the Extremity Soft Tissue Infection(ESTI) Score, which measures the degree of importance/impairment asassessed by patients of their symptoms, daily functioning,emotional functioning, and social interactions.

At the end of treatment (EOT), the investigators assessed that55% of these patients were improved and 26% were cured. Thetreating physician assumes that improved patients progress to acured state without further antibiotics. However, at latefollow-up, 26% of patients who were improved at EOT remainedimproved and had not progressed to a cure.

These patients recordeda 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 tothe 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-upshowed less improvement in lesion size than did cured patients(79.7% vs 99.6%). Overall, they had a higher mean number of signsand symptoms than did cured obese patients at each assessment,showing a mean 1.8 vs 0 for cured patients at late follow-up. Thesepatients also experienced more pain and required 1.4 days ofadditional treatment.

The International Society for Pharmacoeconomics and OutcomesResearch is being held May 16-20, 2015 in Philadelphia, PA. Afterthe conclusion of the meeting, Melinta will make the posteravailable for download on the company’s website.

PROCEED is comprised of two Phase 3 studies, RX-3341-302 andRX-3341-303, the latter of which continues to enroll patients underthe special protocol assessment (SPA) agreed to with the USFDA.