Clinical Trials

Date: 2018-10-05

Type of information: Publication of results in a medical journal

phase: observational

Announcement: publication of results in Open Forum Infectious Diseases

Company: Melinta Therapeutics (USA - CT)

Product: Orbactiv™ (oritavancin)

Action mechanism:

  • antibiotic. Oritavancin is a semisynthetic lipoglycopeptide analogue of vancomycin that contains the heptapeptide core common to all glycopeptides. Oritavancin’s mechanism of action involves at least 3 known mechanisms: inhibition of transglycosylation, inhibition of transpeptidation, and cell membrane interaction/disruption. This antibiotic has been developed by Targanta Therapeutics. This company has been bought out by The Medicines Company in January 2009.
  • In January 2018, The Medicines Company has closed the sale of its infectious disease business unit to Melinta Therapeutics.
  • Orbactiv™ is approved in the United States and European Union for the treatment of adult patients with acute bacterial skin and skin structure infection (ABSSSI) caused by designated, susceptible gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).

Disease: infections due to presumed or confirmed gram-positive bacteria

Therapeutic area: Infectious diseases

Country: USA

Trial details:

  • CHROME is a multicenter, multiyear, retrospective observational study to characterize the demographics and outcomes of adult patients who have received Orbactiv for the treatment of infections due to presumed or confirmed gram-positive bacteria and to describe the associated clinical and microbiologic outcomes and safety.
  • Some of the limitations of a registry such as CHROME include the retrospective, noncomparative, unblinded, and nonrandomized nature of the data from a limited number of sites. Assessment of efficacy was based on a subjective assessment extracted from the medical record by the investigators. The rates of treatment emergent adverse events in this study was much lower than those seen in the SOLO trials, and in some cases the severity of the treatment emergent adverse events (TEAEs) experienced was different. Although there was a difference in the incidence of adverse events (AEs) in CHROME vs. SOLO, the types of AEs seen were consistent with those seen in SOLO. The AEs observed in this smaller patient population are not necessarily representative of what may be seen with treatment with oritavancin. (NCT03159403)

Latest news:

  • • On October 5, 2018, Melinta Therapeutics announced  that findings from the first phase of the ongoing Clinical and Historic Registry and Orbactiv® Medical Evaluation (CHROME) registry, a retrospective observational registry that seeks to characterize the use of Orbactiv® (oritavancin) for injection in real-world settings, have been published in the journal, Open Forum Infectious Diseases. The findings showed safety and efficacy outcomes for Orbactiv in the real-world setting that were consistent with those seen in the previously published Orbactiv Phase 3 SOLO program.
  • In the retrospective, observational registry, data was recorded from 112 patients who received a single dose of Orbactiv at eight healthcare sites for presumed skin and soft tissue infections are summarized in the publication. Clinical success was observed in 103 of 111 evaluable patients (92.8%). This clinical success rate is nearly identical to the 92.6% observed in the pooled Phase 3 SOLO studies that formed the basis of the Orbactiv marketing approval.
  • More individuals in the real-world registry than in SOLO presented with comorbidities such as obesity and diabetes that are typically associated with poor treatment outcome. In addition, 71% of patients in CHROME received prior antibiotic therapy for their infections, compared to only 20% in the SOLO studies. Four patients (3.6%) were hospitalized when their primary infection failed to improve or recurred within 28 days following Orbactiv administration.
  • Safety was evaluable in all 112 patients. Five (4.5%) patients experienced at least one adverse event probably or likely related to Orbactiv; no drug-related serious adverse events (SAEs) were reported. Of the 48 confirmed gram-positive pathogens recovered, 77.1% were caused by Staphylococcus aureus, the majority of which were multi-drug resistant (78.4%).

Is general: Yes