CombinatoRx Drug Candidate CRx-102 Demonstrates Positive Phase 2 Study Results in Hand Osteoarthritis; Trial Meets Primary Endpoint with Statistically Significant Reduction in Pain
BOSTON--(BUSINESS WIRE)--Jan. 30, 2006--CombinatoRx, Incorporated
(NASDAQ: CRXX) today announced positive preliminary results of its
randomized, blinded, placebo-controlled phase 2 clinical trial of
CRx-102 in patients with osteoarthritis (OA) of the hand. The study
met its primary endpoint of improvement in the AUSCAN visual analogue
pain scale. Analysis of the primary endpoint shows mean change from
baseline in the CRx-102 group was -102.4mm (a 33% improvement in pain)
compared to mean change from baseline in the placebo group of -30.9mm
(a 10% improvement). This improvement in pain was statistically
significant with p=0.006. CRx- 102 is a novel synergistic combination
drug candidate discovered and developed by CombinatoRx using
CombinatoRx's combination high throughput screening technology.
CRx-102 was generally well tolerated and there were no serious
adverse events reported. The most common adverse events observed with
CRx-102 were headache and nausea, known side effects of one of the two
"The preliminary results from this first phase 2a trial of CRx-102
give a strong indication of efficacy in hand OA with a good safety
profile," said Dr. Jan Lessem, Chief Medical Officer of CombinatoRx.
"We look forward to completing the secondary analyses, presenting the
data in an appropriate medical forum, and finalizing our further
development plans for this product candidate."
"This preliminary data on CRx-102 has provided the first
statistically significant demonstration of a clinically beneficial
effect in chronic disease for one of our drug candidates and provides
evidence of successful translation of our drug discovery technology
platform into human clinical data," said Alexis Borisy, President and
CEO of CombinatoRx.
CRx-102 is currently under study in two further phase 2 clinical
trials in patients with rheumatoid arthritis and in a systemic
inflammatory disease model, chronic adult periodontitis. CRx-102 is
one of a portfolio of seven product candidates that CombinatoRx is
currently testing in phase 2 clinical trials.
About the Trial Design
This trial was a multi-center, blinded, placebo-controlled,
randomized study of the effect of a 6- week treatment of CRx-102
compared to placebo in a 1:1 ratio with a primary endpoint of pain
relief in subjects with hand osteoarthritis as measured by the AUSCAN
pain subscale index. The AUSCAN Osteoarthritis Index is a visual
analogue scale (VAS) developed specifically for hand osteoarthritis,
similar to the WOMAC index which is used for knee and joint
Secondary endpoints of the study include assessment of the patient
global assessment, the AUSCAN physical function subscale, pain relief
of joints of the hand, and biomarkers.
Patients were enrolled who had moderate to severe hand OA as
determined by ACR criteria and a minimum score on the AUSCAN scale.
CRx-102 was dosed in this trial using 3mg of prednisolone and two
different doses of dipyridamole. Patients received the first ratio for
the first week of treatment, and the second ratio for the following
five weeks. Enrollment of 83 subjects was completed at four Norwegian
CRx-102 is a novel orally available syncretic drug candidate in
clinical development for immunoinflammatory diseases. A syncretic drug
comprises two compounds that are designed to act together
synergistically through multiple pathways to provide a novel
therapeutic effect which neither component alone can achieve. CRx-102
contains a low dose of prednisolone and dipyridamole. The target
product profile for CRx-102 is to selectively amplify certain elements
of prednisolone's anti-inflammatory and immunomodulatory effects,
without replicating steroid toxicity.
Osteoarthritis is the most common degenerative joint disease and a
frequent cause of physical disability among older adults. In the
United States more than 21 million people suffer from the disease(1).
OA affects the hands, lower back, neck, and weight-bearing joints such
as the knees, hips, and foot joints. Symptoms of OA range from
stiffness and intermittent mild pain to severe joint pain and impaired
biomechanical function. Although there is no cure for most forms of
OA, various therapies can help patients manage symptoms such as
non-steroidal anti-inflammatory drugs, COX-2 inhibitors, local
analgesics, intra-articular corticosteroid injection and surgery.
Analyst Briefing on January 31, 2006
CombinatoRx, Incorporated will discuss these preliminary results
from this clinical trial at its analyst day meeting tomorrow, Tuesday,
Jan. 31, 2006 at 8:30 am EST. The meeting will be held at the
Millennium Broadway Hotel in New York City and may be accessed live
via webcast by visiting www.combinatorx.com.
CombinatoRx, Incorporated is a biopharmaceutical company focused
on developing new medicines built from synergistic combinations of
approved drugs, designed to attack disease on multiple fronts.
CombinatoRx applies its proprietary combination drug discovery
technology to identify new combination product candidates in a number
of disease areas, including immuno- inflammatory disease, oncology,
metabolic disease, neurodegenerative disease, and infectious disease.
By applying our proprietary screening technology, we have discovered
and advanced into clinical trials a portfolio of seven product
candidates targeting multiple diseases. For further information,
please visit the CombinatoRx website at www.combinatorx.com.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
concerning ongoing analyses of the clinical trial results and related
publications, CombinatoRx's timeframe for the announcement of results
from clinical trials of its other product candidates, its plans for
further research and development of its CRx- 102 product candidate,
its plans with respect to the research and development of its product
candidates and its drug discovery technology. These forward-looking
statements about future expectations, plans and prospects of
CombinatoRx involve significant risks, uncertainties and assumptions,
including risks related to its ability to initiate and successfully
complete clinical trials of its product candidates, the unproven
nature of the CombinatoRx drug discovery technology, potential
difficulty and delays in obtaining regulatory approval for the sale
and marketing of its product candidates, the Company's ability to
obtain additional funding for its research and development and those
other risks that can be found in the "Risk Factors" section of
CombinatoRx's Registration Statement on Form S-1 on file with the
Securities and Exchange Commission. No forward-looking statement can
be guaranteed and actual results may differ materially from those
In addition, the forward-looking statements included in this press
release represent CombinatoRx's views as of the date of this release.
CombinatoRx anticipates that subsequent events and developments will
cause its views to change. However, while CombinatoRx may elect to
update these forward-looking statements at some point in the future,
CombinatoRx specifically disclaims any obligation to do so, except as
required by applicable law. These forward-looking statements should
not be relied upon as representing CombinatoRx's views as of any date
subsequent to the date of this release. CRx-102 has not been approved
for use by the United States Food and Drug Administration for
osteoarthritis and CombinatoRx has not applied for approval of CRx-102
for the treatment of osteoarthritis.