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Clinical Trials

Date: 2015-10-09

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at IDweek

Company: Melinta Therapeutics (USA - CT)

Product: delafloxacin

Action mechanism:

  • antibiotic. Delafloxacin is an investigational anionic fluoroquinolone antibiotic currently in Phase 3 clinical 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 FDA.

Disease: acute bacterial skin and skin structure infections (ABSSSI)

Therapeutic area: Infectious diseases

Country: Croatia, Israel, Latvia, Russian Federation, Spain, Ukraine, USA

Trial details:

  • RX-3341-302 is a double-blind, Phase 3, multicenter study evaluating the effects of delafloxacin versus vancomycin plus aAztreonam in the treatment of patients with complicated bacterial and soft tissue infections. 660 patients with ABSSSIs were randomized to receive either intravenous (IV) delafloxacin or vancomycin plus aztreonam for 5-14 days. Patients had wounds, burns, major abscesses, or cellulitis with lesions of at least 75 cm2 in size (average lesion size was 307 cm2) and at least 2 systemic signs of infection. Staphylococcus aureus was the most frequently identified pathogen, with 52% being methicillin-resistant (MRSA). Patients were evaluated for efficacy through assessments of signs and symptoms of infection; measurement of lesion size; and culture and susceptibility testing of bacterial isolates.(NCT01811732)

Latest news:

  • • On October 9, 2015, Melinta Therapeutics announced that complete results from the first of two Phase 3 studies (RX-3341-302) of delafloxacin in late-stage development for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) have been presented  at ID Week. Delafloxacin met the study’s primary endpoint, reduction in lesion size by at least 20% at 48-72 hours in the intent-to-treat (ITT) population without nonstudy antibiotics or major procedures, which was comparable to the response in the control arm receiving vancomycin plus aztreonam.
  • Delafloxacin also was comparable to vancomycin+aztreonam in the study’s secondary endpoint of cure, defined as the complete resolution of signs and symptoms at the follow-up visit (Day 14).
  • Delafloxacin-treated patients experienced fewer treatment-emergent adverse events, and fewer discontinuations due to adverse events than patients in the vancomycin+aztreonam arm. The most frequent adverse events in the delafloxacin arm were infection, infusion site extravasation, diarrhea, and nausea.
  • Melinta also provided an analysis of obese patients in this study. Among study participants, 214 patients had body mass index (BMI) of at least 30 kg/m2. More obese patients in the delafloxacin arm achieved cure than in the vancomycin+aztreonam arm.
 

Is general: Yes