Melinta Therapeutics, a privately held commercial-stage company
developing and commercializing novel antibiotics to treat serious
bacterial infections, announced that results from the company’s
first Phase 3 PROCEED study (Study 302; NCT01811732) were published
in the Journal of Antimicrobial Chemotherapy. Study 302 was a
multicenter, randomized, double-blind, active-controlled study that
evaluated Baxdela™ (delafloxacin) compared with the combination
regimen of vancomycin and aztreonam in 660 patients with ABSSSI
(acute bacterial skin & skin structure infections). In
assessment of the key endpoint, Baxdela was noninferior to
vancomycin / aztreonam combination therapy in the Objective
Response, showing reduction of at least 20% in lesion size at
48-to-72 hours, thereby meeting the primary endpoint.
Importantly, Baxdela displayed robust activity in two
challenging patient populations in this study: patients with
confirmed MRSA infections as well as obese patients (those with
body mass indices [BMI] greater than 30 kg/m2). Baxdela
monotherapy was comparable to vancomycin / aztreonam combination
therapy in treating MRSA patients, as well as patients with
obesity. Approximately 24% of patients in Study 302 had a
confirmed MRSA infection and 32% of patients were obese.
Baxdela was well tolerated. The most common adverse events in
Baxdela treated patients were gastrointestinal in nature with mild
to moderate diarrhea reported in 8.3% of patients. Only three
patients (0.9%) discontinued Baxdela therapy due to adverse events,
compared to 14 patients (4.3%) who discontinued vancomycin /
aztreonam combination therapy. There were no cases of C.
difficile diarrhea nor were there any Baxdela-related cases of
tendinitis or tendon rupture, peripheral neuropathy or
myopathy.
Sue Cammarata, M.D., Melinta’s chief medical officer, explained,
“Unlike vancomycin, Baxdela does not require weight-based dosing or
therapeutic drug monitoring, which is more convenient when treating
obese patients. Baxdela also has an oral formulation which
allows for transition to treatment outside of the hospital setting,
including patients with ABSSSI due to MRSA.”
For more information, please refer to the article published as
part of the overall Baxdela publication plan: Pullman J. et al.
Efficacy and safety of delafloxacin compared with vancomycin plus
aztreonam for acute bacterial skin and skin structure infections: a
Phase 3, double-blind, randomized study. J Antimicrob Chemother.
2017 [ePub ahead of print]
Baxdela was approved in June 2017 by the FDA for treatment of
ABSSSI and is currently undergoing Phase 3 testing in patients with
CABP (community-acquired bacterial pneumonia).
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
Grafico Azioni Cempra (NASDAQ:CEMP)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Cempra (NASDAQ:CEMP)
Storico
Da Giu 2023 a Giu 2024