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Melinta Therapeutics Publishes Complete Results from Phase III TANGO 2 Study of Vabomere™ (meropenem and vaborbactam)
- Vabomere monotherapy was associated with increased clinical cure, decreased mortality, and was well tolerated compared to best available therapy (BAT) -
- Data used by CMS in decision to grant a new technology add-on payment (NTAP) for Vabomere, effective Oct. 1, 2018 -
NEW HAVEN, Conn., Oct. 02, 2018 (GLOBE NEWSWIRE) -- Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced that results from the Phase III TANGO 2 study of Vabomere™ (meropenem and vaborbactam) have been published in Infectious Diseases and Therapy1. Data from TANGO 2 showed that Vabomere was associated with increased clinical cure, and decreased mortality compared to “best available therapy” (BAT).
Vabomere was approved by the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae. The Vabomere approval was supported by TANGO 1, a Phase III, multi-center, randomized, double-blind, double-dummy study evaluating the efficacy, safety and tolerability of Vabomere compared to piperacillin-tazobactam in the treatment of cUTI. The Vabomere development program was supported by a cost-share contract with the Biomedical Advanced Research and Development Authority (BARDA).
Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO) 2 was a multi-center, randomized, open-label, pathogen-directed, descriptive study of monotherapy VABOMERE 4 g IV infused every eight hours over three hours for up to 14 days compared with BAT for the treatment of patients with cUTI, acute pyelonephritis (AP), complicated intra-abdominal infection (cIAI), hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP), and bacteremia due to carbapenem-resistant Enterobacteriaceae (CRE).
1 Wunderink, R.G., Giamarellos-Bourboulis, E.J., Rahav, G. et al. Infect Dis Ther (2018). https://doi.org/10.1007/s40121-018-0214-1
TANGO 2 demonstrated cure rates of 65.6% (21/32) vs 33.3% (5/15) at end of therapy (EOT) and 59.4% (19/32) vs 26.7% (4/15) at test of cure (TOC) for Vabomere and BAT, respectively, in patients with a baseline CRE organism. Day 28 all-cause mortality was 15.6% (5/32) for patients treated with Vabomere vs 33.3% (5/15) for patients treated with BAT.
In the safety population, Vabomere was well-tolerated in these seriously ill patients, whether looking at the incidence of treatment-emergent adverse events (TEAEs) compared to BAT [84.0% (42/50) vs 92.0% (23/25)], severe TEAEs [14.0% (7/50) vs 28.0% (7/25)], drug-related TEAEs [24.0% (12/50) vs 44.0% (11/25)], and serious AEs [34.0% (17/50) vs 44.0% (11/25)]. The most common treatment-related adverse events for Vabomere were diarrhea, anemia, and hypokalemia. Vabomere was associated with fewer AEs and nephrotoxicity compared to BAT.
“These published results further demonstrate the safety and effectiveness of Vabomere and underscore our belief that it represents an important new treatment option for patients with serious infections, such as cUTI,” said Dan Wechsler, President and CEO of Melinta. “We believe that Vabomere represents a significant new advancement in addressing the increasing incidence of KPC-producing Enterobacteriaceae, for which there are currently limited treatment options.”
“Treatment options for CRE infections are limited and such infections remain associated with high clinical failure and mortality rates, particularly in vulnerable patient populations,” said Dr. Richard Wunderink, MD, Professor of Medicine, Northwestern University. “It is essential that products such as Vabomere continue to be developed and brought to market where they can play an important role in treating these infections.”
TANGO 2 is the first prospective, Phase III comparative trial of monotherapy with a novel antibiotic in patients with CRE infections.
Data from TANGO 2 was used by the Centers for Medicare & Medicaid Services (CMS) in its decision to grant a new technology add-on payment (NTAP) for Vabomere, effective Oct. 1, 2018.
The NTAP program will provide hospitals with a payment, in addition to the standard-of-care Diagnostic Related Group (DRG) reimbursement, of up to 50% of the cost of Vabomere for a period of two to three years, effective in the 2019 fiscal year starting on October 1, 2018. CMS has assigned a maximum payment of $5,544.00 for a Medicare patient treated with Vabomere. Over 80% of Vabomere’s current and projected utilization among all patients is in the hospital inpatient setting.
About VABOMERE™ (meropenem and vaborbactam) for Injection
VABOMERE (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex. Indications supported by TANGO 2 data have not yet been formally reviewed by the FDA.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs.
Warnings and Precautions
Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam antibacterial drug. If an allergic reaction to VABOMERE occurs, discontinue the drug immediately.
Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including VABOMERE, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued.
The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. If administration of VABOMERE is necessary, consider supplemental anticonvulsant therapy.
In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported.
Alert patients receiving VABOMERE on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment.
Prescribing VABOMERE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of drug-resistant bacteria.
As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of non-susceptible organisms.
The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea.
Please see www.VABOMERE.com for the full FDA-approved prescribing information.
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 www.melinta.com for more information.
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