Rib-X Pharmaceuticals Reports Positive Phase 2 Study Results for Radezolid in Community-Acquired Pneumonia
- Oxazolidinone Demonstrates Both Safety and Efficacy in the Treatment of Community-Acquired Pneumonia -
NEW HAVEN, Conn., Aug. 5 /PRNewswire/ -- Rib-X Pharmaceuticals,
Inc. ("Rib-X" or the "Company"), a development-stage company
focused on the discovery, development and commercialization of
novel antibiotics for the treatment of antibiotic-resistant
infections, today announced positive results from a Phase 2
clinical trial of radezolid in the treatment of community-acquired
pneumonia (CAP).
In the double-blind study, radezolid was administered orally at
three different doses: 300 mg once daily (QD), 450 mg QD and 450 mg
twice daily (BID). This novel oxazolidinone showed comparable
efficacy across all three doses, with clinical cure rates in the
clinically evaluable population ranging from 78% to 92%. Radezolid
also showed excellent activity against a number of key CAP
pathogens including Streptococcus pneumoniae, methicillin-sensitive
Staphylococcus aureus, Haemophilus influenzae and atypical
respiratory pathogens. Additionally, radezolid was well tolerated,
with the most commonly reported adverse events being mild
gastrointestinal upset. No hematological adverse events were
reported in this study.
"We are extremely encouraged by the positive results we've seen
in this Phase 2 trial of radezolid in community-acquired
pneumonia," said Susan Froshauer, PhD, President and CEO of Rib-X
Pharmaceuticals. "Together with the previously reported positive
results of the Phase 2 trial in uncomplicated skin infections, we
are confident in the potential for radezolid to offer a safe
therapeutic alternative for the treatment of methicillin-resistant
Staphylococcus aureus and other bacterial infections. Radezolid has
been shown to be efficacious and appears to have a favorable safety
profile compared to other oxazolidinone compounds. We are looking
forward to progressing the development of radezolid with the
intravenous formulation in a more complicated disease
setting."
CAP Phase 2 Trial Design
This Phase 2 trial was a multicenter, randomized, double-blind
study designed to evaluate the safety and efficacy of radezolid in
the treatment of adult patients with mild to moderate
community-acquired pneumonia (CAP). The study assessed the efficacy
of three doses of radezolid, administered either once or twice a
day for seven to 10 days. It also evaluated the safety and
tolerability of the three doses. The study enrolled approximately
160 patients at 40 study centers across the U.S., Canada, and
Russia. The primary efficacy endpoint was clinical response at the
test of cure (TOC) visit for the clinically evaluable
population.
About Community Acquired Pneumonia (CAP)
Community-acquired pneumonia (CAP) can be caused by a variety of
bacteria and viruses and is the seventh most common cause of death
in the United States. Bacterial CAP is most often caused by
pathogens such as S. pneumoniae and H. influenzae. CAP affects
approximately 5.6 million patients in the United States each year
and results in approximately 2 million hospitalizations
annually.
About Radezolid
Radezolid is a novel oxazolidinone that was discovered using
Rib-X's proprietary discovery process and was designed to expand
the bacterial spectrum and improve the utility of this class of
antibiotics relative to the only other oxazolidinone marketed in
the world, Zyvox (linezolid). Rib-X is developing both oral and IV
formulations for use in serious Gram-positive infections, including
those caused by MRSA and linezolid- and vancomycin-resistant
enterococci. Radezolid has also completed a Phase 2 trial in
uncomplicated skin and skin structure infections (uSSSI). In in
vitro studies, radezolid has demonstrated greater potency than
linezolid against a variety of Gram-positive organisms; radezolid
is also active against linezolid-resistant isolates.
About Rib-X Pharmaceuticals, Inc.
Rib-X Pharmaceuticals, Inc. is a product-driven small molecule
drug discovery and development company focused on the
structure-based design of new classes of antibiotics. The Company's
underlying drug discovery engine capitalizes on its proprietary
high-resolution crystal structure of the ribosome, which performs
an essential role in protein synthesis. Many known, commercially
valuable antibiotics exert their effects by binding to the
bacterial ribosome. The Company's integrated research strategy,
which combines state-of-the-art, proprietary computational
analysis, X-ray crystallography, medicinal chemistry, microbiology
and biochemistry, allows it to rapidly synthesize new agents
designed to avoid typical antibiotic resistance mechanisms. Rib-X's
iterative intelligent engine has yielded several distinctive new
antibiotics, including radezolid that can be used for the treatment
of either community- or hospital-acquired infections. The Company
is also pursuing two other internal discovery programs, RX-04 and
RX-02. The RX-04 discovery program is developing novel classes of
antibiotics active against multi-drug resistant Gram-negative
bacteria and the RX-02 discovery program is focused on developing
an IV/oral macrolide active against methicillin-resistant S.
aureus, multidrug-resistant S. pneumoniae and S. pyogenes. In
addition to these internally developed programs, Rib-X is also
currently preparing to enter Phase 3 clinical trials with
delafloxacin (RX-3341), a novel quinolone that is effective against
quinolone-resistant Gram-positive infections.
For more information on the Rib-X mission and the pipeline,
please visit the Company website at www.rib-x.com.
For further information please contact: Media: Irma Gomez-Dib FD Life Sciences Tel: 212-850-5761 irma.gomez-dib@fd.com Investors: John Capodanno FD Life Sciences Tel: 212-850-5705 John.capodanno@fd.com
Source: Rib-X Pharmaceuticals, Inc.
CONTACT: Media, Irma Gomez-Dib, +1-212-850-5761, irma.gomez-dib@fd.com,
or Investors, John Capodanno, +1-212-850-5705, John.capodanno@fd.com, both
of
FD Life Sciences
Web Site: http://www.rib-x.com/
Posted: August 2009
