Melinta Therapeutics Publishes Findings from Orbactiv® (oritavancin) Real-World Registry Demonstrating Efficacy and Safety Consistent with Phase 3 SOLO Program

New Haven, Connecticut, UNITED STATES

NEW HAVEN, Conn., Oct. 05, 2018 (GLOBE NEWSWIRE) -- Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, announced today 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 Diseases1. 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.

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).

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%).

“These real-world results provide valuable insight into the real-world clinical use of Orbactiv,” said Sue Cammarata, MD, Chief Medical Officer of Melinta Therapeutics. “With most patients in CHROME receiving Orbactiv in an outpatient setting, the registry results highlight the important therapeutic option Orbactiv can provide for many patient populations. Furthermore, the prevalence of MRSA in the CHROME registry, as well as the high rate of prior antibiotic failures, underscore Orbactiv’s role as an important treatment option for patients from these challenging populations.”


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.

About Melinta Therapeutics

Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela® (delafloxacin), Vabomere® (meropenem and vaborbactam), Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. Visit for more information.

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1 Redell M et, al; A Real-world Patient Registry for Oritavancin Demonstrates Efficacy and Safety Consistent with the Phase 3 SOLO Program, 2018 Open Forum Infectious Diseases, June; 5(6)