– Met primary endpoint of Early Clinical Response at 96 hours after the first dose –
– Supplemental NDA expected to be filed with FDA in 1H 2019 –
– Baxdela currently FDA approved for treatment of adult patients with ABSSSI –
NEW HAVEN, CT, USA I October 29, 2018 I Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced positive top-line results from its Phase III trial of Baxdela® (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP).
Baxdela was compared to moxifloxacin in this randomized global trial. Baxdela met all key primary and secondary endpoints in the trial, including the study’s primary U.S. Food and Drug Administration (FDA) endpoint showing Early Clinical Response (ECR) with improvement at 96 hours (± 24 hours) after the first dose in at least two of the following symptoms: chest pain, frequency or severity of cough, amount of productive sputum, and difficulty breathing.
In the intent-to-treat population (ITT), IV-to-oral Baxdela met the FDA primary endpoint of statistical non-inferiority (12.5% non-inferiority margin) for the Early Clinical Response at 96 hours (± 24 hours) after initiation of therapy (88.9% ECR in Baxdela patients) compared to IV/oral moxifloxacin (89.0%). The 95% confidence interval for the treatment difference had lower and upper bounds of -4.4% and 4.1%, respectively.
Baxdela also met the FDA secondary endpoint of statistical non-inferiority (90.5%) compared to moxifloxacin (89.7%) based on the investigator’s assessment of Success at the Test of Cure visit (5-10 days after last dose) in the ITT population. Lower and upper bounds of the 95% confidence interval for the treatment difference were -3.3% and 4.8%, respectively.
Data also showed that IV/oral Baxdela successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin. Both intravenous (IV) and oral Baxdela were well tolerated in the study participants. Overall adverse event rates were similar between treatment arms. The most common treatment-emergent adverse events on Baxdela (≥ 2%) were diarrhea and transaminase increases, which were generally mild and did not lead routinely to treatment discontinuation.
“These are highly encouraging results that demonstrate the important role we believe Baxdela can play in treating adult patients with CABP,” said John Johnson, Interim CEO and Director of Melinta. “We anticipate filing a supplemental new drug application for Baxdela for the treatment of CABP with the FDA in the first half of next year. If approved, it would represent an important addition to Baxdela’s label and expand upon its position as a safe and effective treatment option for patients with ABSSSI in both the hospital and community settings.”
“The Phase III results showed compelling outcomes and safety profiles for Baxdela in comparison to moxifloxacin for the treatment of adult patients with CABP,” said Sue Cammarata, MD, Chief Medical Officer of Melinta. “We look forward to moving ahead with its development and potential regulatory approval, with the goal of providing physicians with an important new option in the treatment of these serious, often life-threatening infections.”
“Community-acquired bacterial pneumonia is a common and potentially life-threatening illness, particularly among the elderly and immunocompromised patients,” said G. Ralph Corey, MD, Divisions of Infectious Diseases and Global Health, Duke University Medical Center. “The promising results shown in this study indicate Baxdela has a potential role in treating this serious disease. ”
Baxdela was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. The Menarini Group, Melinta’s commercial and co-development partner, submitted a Marketing Authorization Application (MAA) to the EMA in March 2018 for delafloxacin (to be marketed under the trade name Quofenix in Europe) for the treatment of adult patients with ABSSSI.
Melinta anticipates filing a sNDA with the FDA for Baxdela for the treatment of adult patients with CABP in the first half of 2019. The FDA has designated Baxdela as a Qualified Infectious Disease Product (QIDP) for CABP, and therefore the sNDA for CABP is eligible for FDA priority review.
About Baxdela
Baxdela (delafloxacin) tablets and intravenous injection are approved by the U.S. Food and Drug Administration (FDA) for the treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections). Baxdela was approved by the FDA in 2017 based on its efficacy against both gram-positive and gram-negative pathogens, including MRSA. It was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies Baxdela for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
INDICATION & USAGE
Baxdela is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:
Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis;
Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
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: 26
– Met primary endpoint of Early Clinical Response at 96 hours after the first dose –
– Supplemental NDA expected to be filed with FDA in 1H 2019 –
– Baxdela currently FDA approved for treatment of adult patients with ABSSSI –
NEW HAVEN, CT, USA I October 29, 2018 I Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced positive top-line results from its Phase III trial of Baxdela® (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP).
Baxdela was compared to moxifloxacin in this randomized global trial. Baxdela met all key primary and secondary endpoints in the trial, including the study’s primary U.S. Food and Drug Administration (FDA) endpoint showing Early Clinical Response (ECR) with improvement at 96 hours (± 24 hours) after the first dose in at least two of the following symptoms: chest pain, frequency or severity of cough, amount of productive sputum, and difficulty breathing.
In the intent-to-treat population (ITT), IV-to-oral Baxdela met the FDA primary endpoint of statistical non-inferiority (12.5% non-inferiority margin) for the Early Clinical Response at 96 hours (± 24 hours) after initiation of therapy (88.9% ECR in Baxdela patients) compared to IV/oral moxifloxacin (89.0%). The 95% confidence interval for the treatment difference had lower and upper bounds of -4.4% and 4.1%, respectively.
Baxdela also met the FDA secondary endpoint of statistical non-inferiority (90.5%) compared to moxifloxacin (89.7%) based on the investigator’s assessment of Success at the Test of Cure visit (5-10 days after last dose) in the ITT population. Lower and upper bounds of the 95% confidence interval for the treatment difference were -3.3% and 4.8%, respectively.
Data also showed that IV/oral Baxdela successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin. Both intravenous (IV) and oral Baxdela were well tolerated in the study participants. Overall adverse event rates were similar between treatment arms. The most common treatment-emergent adverse events on Baxdela (≥ 2%) were diarrhea and transaminase increases, which were generally mild and did not lead routinely to treatment discontinuation.
“These are highly encouraging results that demonstrate the important role we believe Baxdela can play in treating adult patients with CABP,” said John Johnson, Interim CEO and Director of Melinta. “We anticipate filing a supplemental new drug application for Baxdela for the treatment of CABP with the FDA in the first half of next year. If approved, it would represent an important addition to Baxdela’s label and expand upon its position as a safe and effective treatment option for patients with ABSSSI in both the hospital and community settings.”
“The Phase III results showed compelling outcomes and safety profiles for Baxdela in comparison to moxifloxacin for the treatment of adult patients with CABP,” said Sue Cammarata, MD, Chief Medical Officer of Melinta. “We look forward to moving ahead with its development and potential regulatory approval, with the goal of providing physicians with an important new option in the treatment of these serious, often life-threatening infections.”
“Community-acquired bacterial pneumonia is a common and potentially life-threatening illness, particularly among the elderly and immunocompromised patients,” said G. Ralph Corey, MD, Divisions of Infectious Diseases and Global Health, Duke University Medical Center. “The promising results shown in this study indicate Baxdela has a potential role in treating this serious disease. ”
Baxdela was approved by the FDA in 2017 for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. The Menarini Group, Melinta’s commercial and co-development partner, submitted a Marketing Authorization Application (MAA) to the EMA in March 2018 for delafloxacin (to be marketed under the trade name Quofenix in Europe) for the treatment of adult patients with ABSSSI.
Melinta anticipates filing a sNDA with the FDA for Baxdela for the treatment of adult patients with CABP in the first half of 2019. The FDA has designated Baxdela as a Qualified Infectious Disease Product (QIDP) for CABP, and therefore the sNDA for CABP is eligible for FDA priority review.
About Baxdela
Baxdela (delafloxacin) tablets and intravenous injection are approved by the U.S. Food and Drug Administration (FDA) for the treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections). Baxdela was approved by the FDA in 2017 based on its efficacy against both gram-positive and gram-negative pathogens, including MRSA. It was given priority review by the FDA due to its designation as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies Baxdela for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
INDICATION & USAGE
Baxdela is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:
Gram-positive organisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis;
Gram-negative organisms: Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
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: 26
