Melinta Therapeutics, a privately held company developing and
commercializing novel antibiotics to treat serious bacterial
infections, announced that it will be making nine poster
presentations and participating in an oral session at the upcoming
IDWeek 2017 annual scientific meeting. These presentations will
provide detailed analyses of the safety and efficacy results from
the two Phase 3 studies of Baxdela™ (delafloxacin) in the treatment
of patients with acute bacterial skin and skin structure infections
(ABSSSI). In addition, in vitro findings characterizing Baxdela’s
activity against pathogens associated with community-acquired
respiratory tract infections will be presented.
Melinta is also sponsoring several educational events for IDWeek
attendees. An open educational gallery is being held on October 3
from 7:00 - 9:00 pm in the Coronado Room at the Marriott Marquis
San Diego Marina. This is followed by an educational reception on
October 4 from 6:00 – 8:00 pm at Eddie V’s Prime Seafood
Restaurant. More information for this event may be found at
www.regonline.com/meetmelinta. Lastly, an educational product
theater presentation, “A New Development in Antibiotics for the
treatment of Acute Bacterial Skin and Skin Structure Infections,”
is being hosted on October 6 from 1:15 - 2:00 pm in Learning Lounge
2, Booth 1035.
Sue Cammarata, MD, Melinta’s chief medical officer, commented,
“As a whole, these presentations will provide a significant dataset
highlighting the compelling outcomes and safety profiles we have
observed with Baxdela against a number of important pathogens in
the treatment of ABSSSI.”
Baxdela is indicated in adults for the treatment of ABSSSI
caused by susceptible organisms. It is currently being assessed in
a Phase 3 clinical trial for community-acquired bacterial pneumonia
(CABP), an indication for which it has received a Qualified
Infectious Disease Product (QIDP) designation from the U.S. FDA.
Baxdela is not approved for use in CABP.
“An estimated 50,000 people die every year from
community-acquired pneumonia. It is particularly dangerous in
patients with weakened immune responses, such as the elderly and
those whose immune systems are compromised,” continued Dr.
Cammarata. “We look forward to concluding the ongoing Phase 3 CABP
study in 2018.”
Poster and presentation details are as follows:
Thursday, October 5, 2017
- Symposium 088: New Antibiotics: What's in the Pipeline. Room:
20ABCD from 2:00-3:30 PM.
- 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.(Q&A session for Symposium 088),
Room: 06DE from 7:00-8:15 AM.
- 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.
- 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:Lyn Baranowski(203)
848-3346news@melinta.com
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