Melinta Therapeutics, a privately held commercial-stage company
developing and commercializing novel antibiotics to treat serious
bacterial infections, announced nine poster presentations and an
oral presentation at the IDWeek 2017 annual scientific meeting.
Among these posters are three (poster numbers 1856-8) that
detail the microbiologic outcomes and safety results from the two
Phase 3 PROCEED studies of Baxdela™ (delafloxacin) in the
treatment of patients with acute bacterial skin and skin structure
infections (ABSSSI). Baxdela demonstrated strong activity against
both gram-negative and gram-positive pathogens, including
methicillin-resistant Staphylococcus aureus (MRSA). Importantly,
its activity was consistent in difficult-to-treat patients, such as
those with obesity (42% of the study population) or diabetes (11%
of the study population).
Baxdela demonstrated potency against gram-positive pathogens,
including susceptible and resistant Staphylococcus aureus and
Streptococcus pyogenes, in the PROCEED studies. The microbiologic
eradication (documented or presumed) seen with Baxdela was 98.4%
against Staphylococcus aureus strains and 94.7% against
Streptococcus pyogenes in the evaluable group, which were
comparable outcomes to vancomycin/aztreonam combination.
Gram-negative pathogens, including Klebsiella pneumoniae,
Enterobacter cloacae, Escherichia coli and Pseudomonas aeruginosa
were observed in the same studies. Treatment with Baxdela generated
microbiologic eradication (documented or presumed) of 100% for
Klebsiella pneumoniae, Escherichia coli and Pseudomonas aeruginosa,
and 91.7% for Enterobacter cloacae, in evaluable
patients.
Overall, Baxdela was well tolerated in the 741 ABSSSI patients
who received Baxdela in the PROCEED studies. The most frequent
treatment-related adverse events were gastrointestinal in nature
including nausea (in 6.1% of Baxdela-treated patients and 4.3% of
vancomycin/aztreonam -treated patients) and diarrhea (6.1% and 2%,
respectively). Less than 1% of Baxdela-treated patients
discontinued treatment due to adverse events. Notably, there were
no cases of tendon rupture or reports of patients with symptoms
consistent with fluoroquinolone-associated disability (FQAD), a
constellation of symptoms associated with peripheral nerve damage
as qualified by the Food and Drug Administration (FDA) in
2015.
Details of the Baxdela presentations are as follows:
Thursday, October 5, 2017
- Symposium 088: New Antibiotics: What's in the Pipeline. Room:
20ABCD from 2:00-3:30 PM PT.
- Poster 331: Molecular Characterization of Fluoroquinolone
Resistance Mechanisms in Isolates from the Delafloxacin Acute
Bacterial Skin and Skin Structure Infections Clinical Trials.
Friday, October 6, 2017
- Session 107: Pipeline 2.0. Room: 06DE from 7:00-8:15 AM PT
- Poster 1208: In vitro Evaluation of Delafloxacin Activity When
Tested against Contemporary Community-Acquired Bacterial
Respiratory Tract Infection Isolates (2014-2016): Results from the
SENTRY Antimicrobial Surveillance Program
- Poster 1222: Activity of Delafloxacin When Tested Against
Bacterial Surveillance Isolates Collected in The USA And Europe
During 2014-2016 As Part of A Global Surveillance Program
- Poster 1532: Human Target Attainment Probabilities for
Delafloxacin against Escherichia coli and Pseudomonas
aeruginosa
Saturday, October 7, 2017
- Poster 1851: Population Pharmacokinetic and
Pharmacokinetic-Pharmacodynamic Target Attainment Analyses for
Delafloxacin to Support Dose Selection for the Treatment of
Patients with Acute Bacterial Skin and Skin Structure Infections
(ABSSSI)
- Poster 1854: Impact of Delafloxacin and Vancomycin/Aztreonam on
Resolution of Signs and Symptoms of Acute Bacterial Skin and Skin
Structure Infections
- Poster 1856: Outcomes with IV/oral Delafloxacin Compared to
Vancomycin/Aztreonam in Treatment of Patients with Acute Bacterial
Skin and Skin Structure Infections and Gram-negative Pathogens
- Poster 1857: Outcomes with IV/oral Delafloxacin Compared to
Vancomycin/Aztreonam in Treatment of Patients with Acute Bacterial
Skin and Skin Structure Infections and Gram-positive Pathogens
- Poster 1858: Comparison of Safety Profile of Delafloxacin
versus Vancomycin/Aztreonam in the Treatment of Patients with Acute
Bacterial Skin and Skin Structure Infections: Integrated Safety
Findings from Two Phase III Studies
About IDWeekIDWeek is the combined annual
meeting of the Infectious Diseases Society of America (IDSA), the
Society for Healthcare Epidemiology of America (SHEA), the HIV
Medicine Association (HIVMA), and the Pediatric Infectious Diseases
Society (PIDS). With this year’s theme - Advancing Science,
Improving Care - IDWeek features the latest science and
bench-to-bedside approaches in prevention, diagnosis, treatment,
and epidemiology of infectious diseases, including HIV, across the
lifespan. The meeting is being held October 5-8 in San Diego, CA.
For more information, please visit: www.idweek.org.
About Baxdela
Baxdela (delafloxacin) tablets and intravenous injection
are approved for the treatment of ABSSSI (Acute Bacterial Skin and
Skin Structure Infections). Baxdela 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.
IMPORTANT SAFETY INFORMATION:WARNING:
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE,
PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, AND
EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones have been associated with disabling and
potentially irreversible serious adverse reactions that have
occurred together, including:
- Tendinitis and tendon rupture
- Peripheral neuropathy
- Central nervous system effects
Discontinue Baxdela
immediately and avoid the use of fluoroquinolones,
including Baxdela, in patients
who experience any of these serious adverse reactions.
Fluoroquinolones may exacerbate muscle weakness in
patients with myasthenia gravis. Avoid Baxdela in patients with
known history of myasthenia gravis.
ContraindicationsBaxdela is contraindicated in
patients with known hypersensitivity to Baxdela or other
fluoroquinolones.
Warnings and PrecautionsRisk of tendinitis,
tendon rupture, peripheral neuropathy and central nervous system
effects is increased with use of fluoroquinolones. Discontinue
Baxdela immediately at the first signs or symptoms of any of these
serious adverse reactions.
Avoid Baxdela in patients with known history of myasthenia
gravis.
Hypersensitivity Reactions may occur after first or subsequent
doses of Baxdela. Discontinue Baxdela at the first sign of
hypersensitivity.
Clostridium difficile-associated diarrhea has been reported in
users of nearly all systemic antibacterial drugs, including
Baxdela. Evaluate if diarrhea occurs.
Prescribing Baxdela in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
Adverse ReactionsThe most common adverse
reactions in patients treated with Baxdela were nausea (8%),
diarrhea (8%), headache (3%), transaminase elevations (3%), and
vomiting (2%).
Use in Specific PopulationsIn patients with
severe renal impairment (eGFR of 15-29 mL/min/1.73 m2) dosing of
Baxdela should be dosed at 200 mg IV every 12 hours or 450 mg
orally every 12 hours. Baxdela is not recommended in patients with
End Stage Renal Disease [ESRD] (eGFR of <15 mL/min/1.73 m2) due
to insufficient information to provide dosing recommendations.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is 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 and better therapeutic solutions.
Melinta’s lead product is Baxdela, an antibiotic approved for use
in the treatment of acute bacterial skin and skin structure
infections (ABSSSI). Melinta is also committed to developing,
through the application of Nobel Prize-winning science, a new class
of antibiotics designed to overcome the multi- and
extremely-drug-resistant pathogens for which there are few to no
options, known collectively as ESKAPE pathogens (Enterococcus
faecium, Staphylococcus aureus, Klebsiella pneumoniae,
Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter
species and Escherichia coli), which cause the majority of
life-threatening hospital infections.
Melinta Therapeutics is privately held and backed by Vatera
Healthcare Partners (www.vaterahealthcare.com) and Malin
Corporation plc (www.malinplc.com), among other private investors.
In August, Melinta announced its entry into a merger agreement with
Cempra, Inc. (Nasdaq:CEMP). The company is headquartered in New
Haven, CT with offices in Lincolnshire, IL.
Visit www.melinta.com for more information.
For More Information:Amra Maynard(917)
302-2702Amra.maynard@inventivhealth.com
Lyn Baranowski(203) 848-3346 news@melinta.com
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