Melinta Therapeutics’ Topical Radezolid Well Tolerated in Phase 1 Study for Treatment of Acne
10 Outubro 2017 - 9:00AM
Melinta Therapeutics, a privately held commercial-stage company
developing and commercializing novel antibiotics to treat serious
bacterial infections, announced today that a Phase 1 clinical study
of topical radezolid for the treatment of mild-to-moderate acne
vulgaris has been successfully completed. Melinta and its partner
enrolled 10 individuals with grade 3-to-4 acne vulgaris who applied
topical radezolid twice daily for four weeks. Results demonstrated
that radezolid was well tolerated with minimal systemic absorption.
Acne is caused by the bacterium, Propionibacterium acnes, and is
one of the most commonly treated skin disorders, affecting up to 50
million Americans. Resistance to antimicrobial treatments for acne
has been shown to be as high as 66 percent. A separate in vitro
study sponsored by Melinta against contemporary (2017) bacterial
strains from acne patients that include isolates resistant to
commonly used topical antibiotic treatment showed that 38 percent
of samples isolated from skin swabs were multi-drug resistant to
macrolides, such as erythromycin, lincosamides, such as
clindamycin, and tetracyclines. Radezolid, a next-generation
oxazolidinone, represents a novel class of antimicrobials to target
acne and demonstrated strong in vitro activity regardless of the
resistance profile of the pathogen, where other agents were not as
active against the resistant pathogens.
“The results of the Phase 1 study as well as earlier testing
against resistant isolates show that radezolid may have the
potential to be an important treatment option for clinicians and
their patients,” stated Eugene Sun, M.D., Melinta’s chief executive
officer. “Radezolid is a second-generation oxazolidinone that
Melinta designed to have higher affinity to a key ribosomal binding
region, which we expect will overcome certain resistance
mechanisms. Its favorable PK and safety profiles may make it
ideally suited for the treatment of acne, and we’re looking forward
to exploring its activity in a planned Phase 2 study.”
As a next step, a 12-week, randomized, double-blind,
vehicle-controlled Phase 2 proof-of-concept study to evaluate the
safety and efficacy of radezolid in approximately 48 individuals
with moderate-to-severe facial acne vulgaris is anticipated to
start by the fourth quarter of 2017. Primary endpoints of interest
will include the Investigator's Global Assessment (IGA) (score of
"clear" or “almost clear”) and the absolute change from baseline of
acne lesion count(s) in each treatment group. Safety and
tolerability will also be assessed.
About Radezolid Radezolid is a
second-generation oxazolidinone discovered by Melinta scientists
using proprietary, structure-based design, to achieve higher
ribosomal binding affinity, minimal off-target activity, and a
broader spectrum of antimicrobial activity than is currently
available in the class. For more information, please visit the
company website.
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 by the US FDA 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
Cempra (NASDAQ:CEMP)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Cempra (NASDAQ:CEMP)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024