Cempra Announces Positive Results From its Phase 2 Clinical Trial of TAKSTA (Sodium Fusidate) in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
CHAPEL HILL, N.C., May 4 /PRNewswire/ -- Cempra Pharmaceuticals
today announced positive results from its Phase 2 clinical trial
evaluating the efficacy and tolerability of the novel front loading
dosing regimen of TAKSTA(TM) (CEM-102, sodium fusidate), the
company's oral, anti-methicillin-resistant Staphylococcus aureus
(MRSA) antibiotic. The study demonstrated efficacy comparable to
linezolid in patients with acute bacterial skin and skin structure
infections (ABSSSI) indicating that TAKSTA will have a high
probability of demonstrating non-inferiority vs. linezolid in
pivotal Phase 3 trials. The TAKSTA loading dose regimen was well
tolerated.
Sodium fusidate has an established track record of efficacy and
safety outside the U.S. for treating gram positive infections,
including MRSA. The novel proprietary oral dosing regimen under
development in the U.S. is based on extensive PK-PD
modeling--employing defined drug loads chosen to optimize the
efficacy and spectrum while preventing selection of resistant
organisms--that was validated in preclinical and Phase 1 single-
and multi-dose clinical trials. In the U.S., TAKSTA is in clinical
development for the treatment of ABSSSI, caused by gram-positive
bacteria, especially drug-resistant strains such as MRSA.
Efficacy and tolerability of the front-loading dose regimen of
TAKSTA were compared to oral linezolid in patients with wound
infections and cellulitis. In this double-blind randomized study,
198 patients were assigned to one of the treatment arms. Drug
administration was for 10-14 days. The loading dose regimen was
well tolerated and showed efficacy comparable to linezolid in this
trial.
"We have applied new advanced methods of PK/PD system analysis
to allow CEM-102's development as monotherapy for serious
staphylococcal and streptococcal skin infections," said Paul G.
Ambrose, Pharm. D., F.I.D.S.A., director, Institute for Clinical
Pharmacodynamics, Ordway Research Institute. "We are very
encouraged that our laboratory work showing that upon proper
exposure to the antibiotic, efficacy can be optimized while at the
same time decreasing the probability resistance will develop on
therapy. The results from the Phase 2 study suggest that we may
have attained these goals."
Michael L. Corrado, M.D. , F.I.D.S.A., a director at Cempra and
chief scientific officer and chief regulatory officer at INC
Research, said " From these data it would appear that CEM 102
offers an additional potential treatment for gram positive skin and
soft tissue infections. There are few drugs which can be given
orally and which could treat both hospital and community acquired
S. aureus infections. If further trials continue to support these
observations they will support the basis of intelligent designing
of clinical trials based on pharmacodynamic methods. This is how
infectious disease trials should be conducted."
Prabhavathi Fernandes, Ph.D., chief executive officer of Cempra
added, "Resistance to current anti-bacterial therapies has
increased in the community and patient enrollment in the trial,
which was completed ahead of expectations, is evidence for the need
of new oral agents to treat these difficult infections that have
the potential to result in death. We believe that
orally-administered TAKSTA will provide physicians the opportunity
to keep patients with serious infections out of the hospital,
thereby reducing costs on the healthcare system and improving
patient convenience and outcomes. We are looking forward to
presenting the complete data set at an upcoming medical conference
this year and to initiating the Phase 3 trial in the near
future."
About TAKSTA(TM)
TAKSTA, (sodium fusidate) is a novel class of antibiotic with an
established history of safety and efficacy outside the United
States. TAKSTA is being developed as an NCE in the U.S. for ABSSI.
Clinical trials with TAKSTA employ a proprietary front-loading oral
regimen designed to optimize efficacy, increase coverage and
minimize resistance development. Cempra believes that TAKSTA will
be an important addition to anti-MRSA therapies based on the
following:
-- Sodium fusidate is orally active against gram-positive bacteria,
including all S. aureus strains such as HA-MRSA and CA-MRSA
-- TAKSTA employs a novel and proprietary PK-PD-based dosing regimen of
sodium fusidate that optimizes efficacy and minimizes the risk of
resistance development
-- Sodium fusidate is the only compound within the fusidane class and
therefore is unlikely to select for cross-resistance to other classes
of antibiotics
-- Sodium fusidate's safety has been well documented even when used for
long periods of time (over one year) to treat osteomyelitis and other
serious infections including cystic fibrosis-associated staphylococcal
infections
-- Sodium fusidate has been used safely in children including neonates in
countries where it is marketed
About 60 to 80 percent of the 13 million acute bacterial skin
structure infections that occur in the U.S. each year caused by
MRSA. There is a growing need for an oral anti-MRSA drug that is
safe, effective and is capable of long-term administration.
About Cempra Pharmaceuticals
Founded in 2006, Cempra Pharmaceuticals is a privately-held,
clinical-stage pharmaceutical company focused on developing
antibacterials to address critical medical needs. Two lead
products, both in late-stage clinical trials, address the urgent
and increasing need for new treatments targeting drug-resistant
bacterial infections in the hospital and in the community. Cempra
is well-funded and is committed to developing commercially and
medically differentiated and novel products that reduce development
risk and provide a high financial return. The company is also
utilizing its proprietary compound library and chemistry technology
to develop novel macrolides without antibacterial activity for
non-antibiotic uses such as COPD, chronic inflammatory and GI
disorders. Additional information about Cempra can be found at
www.cempra.com.
Media Contacts: Robert E. Flamm, Ph.D. Russo Partners, LLC (212) 845-4226 Robert.flamm@russopartnersllc.com Tony Russo, Ph.D. Russo Partners, LLC (212) 845-4251 Tony.russo@russopartnersllc.com
Source: Cempra Pharmaceuticals
CONTACT: Robert E. Flamm, Ph.D., Russo Partners, LLC,
+1-212-845-4226,
Robert.flamm@russopartnersllc.com;
Tony Russo, Ph.D., Russo Partners, LLC,
+1-212-845-4251, Tony.russo@russopartnersllc.com
Web Site: http://www.cempra.com/
Posted: May 2010
