—Fusidic acid met primary endpoint and
secondary efficacy endpoints—
Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company
focused on developing differentiated anti-infectives for the acute
care and community settings to meet critical medical needs in the
treatment of infectious diseases, today announced positive topline
results from a phase 3 study of oral fusidic acid in 716 patients
with acute bacterial skin and skin structure infections (ABSSSI).
Fusidic acid was well tolerated in the study and achieved the
primary endpoint, demonstrating non-inferiority (NI) (10% NI
margin) of oral fusidic acid compared to oral linezolid for early
clinical response (ECR) in the intent to treat (ITT) patient
population.
Study Design and Demographics
The double-blind study was conducted at 62 sites in the United
States. Patients randomized to treatment with oral fusidic acid
received a loading dose of 1500 mg every 12 hours for two doses,
followed by 600 mg every 12 hours thereafter, until the end of a 10
day course of therapy. Patients randomized to treatment with the
active comparator, oral linezolid, received 600 mg every 12 hours
for 10 days. Randomization was 1:1 and was stratified by type of
infection (cellulitis, wound infection, major cutaneous abscess),
by age and by prior use of an antibiotic within 36 hours prior to
randomization.
Overall, 67.5 percent of study subjects had an infection
associated with intravenous drug abuse. Less than five percent of
study subjects received an antibiotic prior to randomization.
Balanced Baseline Demographic
Characteristics
ITT Population |
Fusidic AcidN=359 |
LinezolidN=357 |
Sex, n (%) |
|
|
Male |
244 (68.0) |
218 (61.1) |
Female |
115 (32.0) |
139 (38.9) |
Infection Type, n (%) |
|
|
Major Cutaneous Abscess |
46 (12.8) |
47 (13.2) |
Cellulitis |
92 (25.6) |
92 (25.8) |
Wound Infection |
221 (61.6) |
218 (61.1) |
Prior Antibiotic Usage, n (%) |
|
|
Yes |
17 (4.7) |
18 (5.0) |
No |
342 (95.3) |
339 (95.0) |
Recent or Ongoing IV Drug Abuse, n (%) |
|
|
Yes |
245 (68.2) |
238 (66.7) |
No |
114 (31.8) |
119 (33.3) |
Consistent Efficacy at ECR,
End-of-Treatment (EOT) and Post-therapy Evaluation
(PTE)
The primary endpoint, ECR in the ITT population,
was defined as the proportion of patients alive and achieving a ≥
20 percent reduction from baseline in lesion size at 48-72 hours
after the start of study drug, without receiving rescue
antibiotics. In the study, 87.2 percent of ITT patients receiving
fusidic acid demonstrated ECR, compared to 86.6 percent of ITT
patients receiving linezolid (treatment difference 0.6%, 95%
confidence interval (CI) -4.6, +5.9), demonstrating non-inferiority
to linezolid.
Fusidic acid also showed comparable efficacy to
linezolid in investigator-assessed clinical response in the ITT and
clinically evaluable (CE) populations at EOT and PTE (7-14 days
post-EOT) visits.
Clinical Response by
Population
|
Fusidic Acid |
Linezolid |
Treatment Difference (95% CI) |
ITT Population |
|
|
|
ECR (Primary Endpoint) |
87.2 % (313/359) |
86.6 % (309/357) |
+0.6 (-4.6, +5.9) |
Clinical Success at EOT |
91.9 % (330/359) |
89.6 % (320/357) |
+2.3 (-2.2, +6.8) |
Clinical Success at PTE |
88.6 % (320/359) |
88.5 % (316/357) |
+0.1 (-4.9, +5.0) |
CE Populations |
|
|
|
Clinical Success at EOT (CE-EOT) |
97.1 % (303/312) |
97.3 % (288/296) |
-0.2 (-3.1, +2.8) |
Clinical Success at PTE (CE-PTE) |
95.7 % (292/305) |
96.9 % (283/292) |
-1.2 (-4.5, +2.2) |
Strong Activity Against Key Pathogens,
Including MRSA
Microbiological response rates by pathogen were
high in both treatment groups in both the microbiological ITT
(mITT) and microbiologically-evaluable (ME) patient populations
(patients with isolation of a baseline pathogen, who were also
clinically evaluable). The most common pathogens identified were
Staphylococcus aureus, Streptococcus anginosus group species,
Streptococcus pyogenes and Clostridium species. Notably, the
microbiological success rate among fusidic acid recipients in each
ME population with methicillin-resistant S. aureus (MRSA) infection
was 100 percent (99/99) at both the EOT and PTE visits.
Fusidic Acid Well Tolerated
Fusidic acid was well tolerated in the study. The rates of
treatment-emergent adverse events (TEAEs) were comparable between
treatment groups (37.9 percent fusidic acid, 36.1 percent
linezolid). The most common TEAEs in both treatment groups were
gastrointestinal events (22.8 percent fusidic acid, 18.2 percent
linezolid). Serious adverse events (SAEs) occurred in six fusidic
acid recipients and eight linezolid recipients, and were considered
study-drug related in one fusidic acid recipient (vomiting) and in
two linezolid recipients (one drug induced liver injury, one
vomiting). Adverse events led to study drug discontinuation in 2.2
percent of fusidic acid recipients, and 2.0 percent of linezolid
recipients. There was one death in the study, an event due to
illicit drug overdose and aspiration which occurred in a patient
receiving linezolid. Rates of treatment-emergent ALT elevation to
>3x ULN occurred in 1.0 percent of fusidic acid recipients and
0.7 percent of linezolid patients.
“Considering complicated skin infections are one of the most
rapidly growing reasons for hospitalizations and emergency
department visits each year, the results with fusidic acid in this
study are promising, especially for an outpatient population where
there is a need for new oral drugs that are effective against
MRSA,” said William O’Riordan, M.D., chief medical officer of
eStudySite, leaders in evaluating new therapeutic approaches for
complicated skin infections.
Cempra plans to submit the full data from this study for
presentation at an upcoming scientific forum.
“We are excited that the results of this phase 3 study with
fusidic acid confirm the results of our phase 2 study and are
consistent with the more than 40 years of experience that the
product has accumulated outside the United States,” said David
Oldach, M.D., chief medical officer of Cempra.
“We look forward to meeting with the FDA to discuss the next
steps required to bring fusidic acid to patients in the United
States,” Oldach added.
About Fusidic Acid
Cempra is developing fusidic acid exclusively in the U.S. for
ABSSSI and is exploring its use for the long term oral treatment of
refractory bone and joint infections. Fusidic acid is orally active
against gram-positive bacteria, including Staphylococcus aureus
strains such as healthcare-acquired methicillin-resistant
Staphylococcus aureus (HA-MRSA) and community-acquired MRSA. Cempra
completed a phase 2 clinical trial in patients with ABSSSI, which
is frequently caused by MRSA, demonstrating a tolerability profile
and efficacy comparable to linezolid, one of the few oral
antibiotics with FDA approval for the treatment of MRSA. A phase 2
trial in patients with primarily staphylococcal infections of
prosthetic hip and knee joints demonstrated that fusidic acid, in
combination with rifampin, was generally comparable to intravenous
standard of care antibiotics. Cempra has an ongoing exploratory
study of fusidic acid for chronic oral treatment of refractory
infections in bones and joints.
About Cempra, Inc.
Cempra, Inc. is a clinical-stage pharmaceutical company focused
on developing differentiated anti-infectives for the acute care and
community settings to meet critical medical needs in the treatment
of infectious diseases. Cempra's two lead product candidates are
currently in advanced clinical development. Solithromycin has been
evaluated in two phase 3 clinical trials for community-acquired
bacterial pneumonia (CABP). Cempra is currently seeking approval
for both intravenous and oral capsule formulations from the U.S.
Food and Drug Administration and the European Medicines Agency.
Solithromycin is licensed to strategic commercial partner Toyama
Chemical Co., Ltd., a subsidiary of FUJIFILM Holdings Corporation,
for certain exclusive rights in Japan. Solithromycin is also in a
phase 3 clinical trial for uncomplicated urogenital urethritis
caused by Neisseria gonorrhoeae or chlamydia. Cempra is contracted
with BARDA for the development of solithromycin for pediatric use
and has commenced enrollment in a global phase 2/3 trial to
evaluate the safety and efficacy of solithromycin versus standard
of care antibiotics in children and adolescents from two months to
17 years of age. Fusidic acid is Cempra's second product candidate,
which has completed an initial phase 3 trial comparing fusidic acid
to linezolid in patients with acute bacterial skin and skin
structure infections (ABSSSI). Cempra also has an ongoing
exploratory study of fusidic acid for chronic oral treatment of
refractory infections in bones and joints. Both products seek to
address the need for new treatments targeting drug-resistant
bacterial infections in the hospital and in the community. Cempra
is also studying solithromycin for ophthalmic conditions and has
synthesized novel macrolides for non-antibiotic uses such as the
treatment of chronic inflammatory diseases, endocrine diseases and
gastric motility disorders. Cempra was founded in 2006 and is
headquartered in Chapel Hill, N.C. For additional information about
Cempra please visit www.cempra.com.
Please Note: This press release contains
forward-looking statements regarding future events. These
statements are just predictions and are subject to risks and
uncertainties that could cause the actual events or results to
differ materially. These risks and uncertainties include, among
others: our ability to address the issues identified by the FDA in
the complete response letter relating to our new drug applications
for solithromycin for community acquired bacterial pneumonia; our
ability to obtain FDA and foreign regulatory approval of
solithromycin as a treatment for community acquired bacterial
pneumonia; the impact of the recently announced changes in senior
management and our ability to retain and hire necessary employees
and to staff our operations appropriately; our anticipated capital
expenditures and our estimates regarding our capital requirements,
including the costs of addressing the complete response letter; our
dependence on the success of solithromycin and fusidic acid; our
and our strategic commercial partners' ability to obtain FDA and
foreign regulatory approval of our product candidates; the costs,
sources of funds, enrollment, timing, regulatory review and results
of our studies and clinical trials and those of our strategic
commercial partners; results of our and our strategic commercial
partners' pre-clinical studies and clinical trials are not
predictive of results from subsequent clinical trials for any
possible therapy; our need to obtain additional funding and our
ability to obtain future funding on acceptable terms; the
unpredictability of the size of the markets for, and market
acceptance of, any of our products, including solithromycin and
fusidic acid; our ability to commercialize and launch, whether on
our own or with a strategic partner, any product candidate that
receives regulatory approval; our ability to produce and sell any
approved products and the price we are able to realize for those
products; the possible impairment of, or inability to obtain,
intellectual property rights and the costs of obtaining such rights
from third parties; our ability to compete in our industry;
innovation by our competitors; and our ability to stay abreast of
and comply with new or modified laws and regulations that currently
apply or become applicable to our business. The reader is referred
to the documents that we file from time to time with the Securities
and Exchange Commission.
Company Contact:
John Bluth
Cempra, Inc.
+1 984 209 4534
jbluth@cempra.com
Investor Contact:
Robert Uhl
Westwicke Partners, LLC
+1 858 356 5932
robert.uhl@westwicke.com
Media Contact:
Melyssa Weible
Elixir Health PR
+1 201 723 5805
mweible@elixirhealthpr.com
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