Real-world registry data for Orbactiv in ABSSSI published in Open Forum Infectious Diseases.- Melinta Therapeutics.

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 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), 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 III 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%).

See: "A Real-world Patient Registry for Oritavancin Demonstrates Efficacy and Safety Consistent With the Phase 3 SOLO Program" Mark Redell et al. Open Forum Infectious Diseases, Volume 5, Issue 6, 1 June 2018, ofy051, https://doi.org/10.1093/ofid/ofy051