NEW HAVEN, CT, USA I April 23, 2018 I Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, has presented detailed results from the VABOMERE™ (meropenem and vaborbactam) Phase 3 TANGO II trial at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2018 meeting.
TANGO II was a randomized, open-label study of VABOMERE compared with best available therapy (BAT) in patients with serious infections due to known or suspected carbapenem-resistant Enterobacteriaceae (CRE) infections. VABOMERE was approved by the U.S. Food and Drug Administration in 2017 for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae.
The majority of patients enrolled in TANGO II presented at baseline with severe co-morbidities including compromised immune systems or renal insufficiency, each of which can complicate treatment and have a negative impact on clinical outcomes. At ECCMID, Melinta presented additional data from TANGO II highlighting outcomes in these vulnerable patient populations.
“Co-morbidities in patients with CRE infections pose a particular challenge for physicians,” said Dr. Sue Cammarata, Chief Medical Officer of Melinta. “A majority of patients who were enrolled in TANGO II presented with co-morbidities, providing us with valuable information on the activity of VABOMERE in patient subgroups that are particularly susceptible to CRE infections.”
Summaries of the key findings from poster and oral presentations made at ECCMID 2018 are as follows:
P0285: Meropenem-vaborbactam versus best-available therapy for carbapenem-resistant
Enterobacteriaceae infections in TANGO II: outcomes in patients with cancer. Patients with underlying malignancies and immunocompromised patients are particularly susceptible to CRE infections, which can have a significant impact on mortality. In TANGO II, 43 patients were enrolled who had a confirmed CRE at baseline (mCRE-MITT population). Among these patients, 15 had a prior or ongoing malignancy, the majority of whom were immunocompromised. The eight patients treated with VABOMERE experienced higher clinical cure rates at end of treatment (EOT) and test-of cure (TOC) visits and an improved day-28 mortality (87.5%, 75.0% and 12.5%) compared to the seven who received BAT (14.3%, 0% and 57.1%). In the broader MITT population, the 12 cancer patients treated with VABOMERE reported fewer drug-related adverse events (16.7% vs. 33.3%), serious adverse events (25.0% vs. 77.8%), and renal adverse events (8.3% vs. 22.2%) than did the nine patients treated with BAT.
O0608: Meropenem-vaborbactam versus best available therapy for infections due to carbapenem-resistant Enterobacteriaceae in TANGO II: impact of prior antibiotic failure on clinical outcomes. Nine patients in the mCRE-MITT population had been deemed by the investigator to have failed prior antimicrobials, all of whom were randomized to the VABOMERE arm. To examine clinical cure and day-28 mortality rates in VABOMERE- and BAT-treated patients in comparable populations, these nine prior-failures were excluded from the analysis, which resulted in clinical cure rates for the 19 patients treated with VABOMERE at EOT and TOC of 84.2% and 68.4%, respectively, and 28-day mortality of 5.3%. This compares favorably to the clinical cure rates and 28-day mortality of the 28 patients who received BAT (33.3%, 26.7% and 33.3%, respectively).
P2205: Ex vivo characterization of effects of renal replacement therapy modalities and settings on pharmacokinetics of meropenem-vaborbactam. Individuals with end-stage renal disease (ESRD) receiving renal replacement therapy (RRT) are also at increased risk of infection by carbapenem-resistant organisms. An ex vivo analysis found that there was negligible adsorption of VABOMERE by the dialysis filter.
Overall, VABOMERE was well tolerated in Phase 3 trials. The most common adverse events (≥3% of patients) were diarrhea, anemia, and hypokalemia.
About VABOMERE™ (meropenem and vaborbactam) for Injection
In the U.S, 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.
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.
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.
SOURCE: Melinta Therapeutics
Post Views: 72
NEW HAVEN, CT, USA I April 23, 2018 I Melinta Therapeutics, Inc. (NASDAQ:MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, has presented detailed results from the VABOMERE™ (meropenem and vaborbactam) Phase 3 TANGO II trial at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2018 meeting.
TANGO II was a randomized, open-label study of VABOMERE compared with best available therapy (BAT) in patients with serious infections due to known or suspected carbapenem-resistant Enterobacteriaceae (CRE) infections. VABOMERE was approved by the U.S. Food and Drug Administration in 2017 for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae.
The majority of patients enrolled in TANGO II presented at baseline with severe co-morbidities including compromised immune systems or renal insufficiency, each of which can complicate treatment and have a negative impact on clinical outcomes. At ECCMID, Melinta presented additional data from TANGO II highlighting outcomes in these vulnerable patient populations.
“Co-morbidities in patients with CRE infections pose a particular challenge for physicians,” said Dr. Sue Cammarata, Chief Medical Officer of Melinta. “A majority of patients who were enrolled in TANGO II presented with co-morbidities, providing us with valuable information on the activity of VABOMERE in patient subgroups that are particularly susceptible to CRE infections.”
Summaries of the key findings from poster and oral presentations made at ECCMID 2018 are as follows:
P0285: Meropenem-vaborbactam versus best-available therapy for carbapenem-resistant
Enterobacteriaceae infections in TANGO II: outcomes in patients with cancer. Patients with underlying malignancies and immunocompromised patients are particularly susceptible to CRE infections, which can have a significant impact on mortality. In TANGO II, 43 patients were enrolled who had a confirmed CRE at baseline (mCRE-MITT population). Among these patients, 15 had a prior or ongoing malignancy, the majority of whom were immunocompromised. The eight patients treated with VABOMERE experienced higher clinical cure rates at end of treatment (EOT) and test-of cure (TOC) visits and an improved day-28 mortality (87.5%, 75.0% and 12.5%) compared to the seven who received BAT (14.3%, 0% and 57.1%). In the broader MITT population, the 12 cancer patients treated with VABOMERE reported fewer drug-related adverse events (16.7% vs. 33.3%), serious adverse events (25.0% vs. 77.8%), and renal adverse events (8.3% vs. 22.2%) than did the nine patients treated with BAT.
O0608: Meropenem-vaborbactam versus best available therapy for infections due to carbapenem-resistant Enterobacteriaceae in TANGO II: impact of prior antibiotic failure on clinical outcomes. Nine patients in the mCRE-MITT population had been deemed by the investigator to have failed prior antimicrobials, all of whom were randomized to the VABOMERE arm. To examine clinical cure and day-28 mortality rates in VABOMERE- and BAT-treated patients in comparable populations, these nine prior-failures were excluded from the analysis, which resulted in clinical cure rates for the 19 patients treated with VABOMERE at EOT and TOC of 84.2% and 68.4%, respectively, and 28-day mortality of 5.3%. This compares favorably to the clinical cure rates and 28-day mortality of the 28 patients who received BAT (33.3%, 26.7% and 33.3%, respectively).
P2205: Ex vivo characterization of effects of renal replacement therapy modalities and settings on pharmacokinetics of meropenem-vaborbactam. Individuals with end-stage renal disease (ESRD) receiving renal replacement therapy (RRT) are also at increased risk of infection by carbapenem-resistant organisms. An ex vivo analysis found that there was negligible adsorption of VABOMERE by the dialysis filter.
Overall, VABOMERE was well tolerated in Phase 3 trials. The most common adverse events (≥3% of patients) were diarrhea, anemia, and hypokalemia.
About VABOMERE™ (meropenem and vaborbactam) for Injection
In the U.S, 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.
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.
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.
SOURCE: Melinta Therapeutics
Post Views: 72
