Mr. Donald McCaffrey reports
RESVERLOGIX ANNOUNCES COMBINED RVX-208 FINDINGS FROM SUSTAIN & ASSURE PHASE 2B TRIALS
Resverlogix Corp. has released new information arising from its continuing analysis of data
from both the SUSTAIN and ASSURE trials in atherosclerotic patients
with high risk for recurrent events. This analysis, performed by an
independent firm, focuses on the potential benefit of RVX-208, a first-in-class BET inhibitor, to impact major adverse cardiac events (MACE)
over a short time period of six months.
When MACE data (n equals 499) from both SUSTAIN and ASSURE trials were
combined, it demonstrated that treatment with RVX-208 lead to a
significant reduction in MACE. RVX-208-treated patients (n equals 331) had
less cumulative events of 6.74 per cent versus 15.09 per cent (p equals 0.02) in the placebo-treated group (n equals 168). Furthermore, in patients who had elevated CRP (C-reactive protein) over
two milligrams per decilitre (n equals 283), the benefit of RVX-208 treatment of patients (n equals 179)
appeared more striking with a cumulative event rate of 6.42 per cent versus 20.53 per cent
(p equals 0.007) in the placebo group (n equals 104).
"Analysis of the ASSURE and SUSTAIN data arising from similar
atherosclerotic patients with high risk of recurrent events provides
important MACE information," stated Donald McCaffrey, president and
chief executive officer of Resverlogix. "A reduction in MACE will be a
critical factor for registration of RVX-208. This analysis provides
important information that RVX-208 when used in high-risk
atherosclerosis patients improves the most central measurement of all,
the reduction of MACE in back-to back-trials," said Mr. McCaffrey.
"We are very excited to have this independent MACE analyses performed
from the combined ASSURE and SUSTAIN trials to assess the RVX-208
impact on death, non-fatal myocardial infarct, hospitalizations from
cardiac events and percutaneous invasive procedures or
revascularizations," stated Dr. Jan Johansson, senior vice-president of
medical affairs at Resverlogix. "This early data is valuable to have as
it illustrates in a cumulative fashion that RVX-208 has the potential
to really impact cardiac events in those patients who are at very high
risk," Dr. Johansson added.
About MACE
Major adverse cardiac events refers to adverse events caused by
disease processes generally affecting the coronary arteries. These may
include what are termed hard events, such as deaths that are
attributed to coronary artery disease and non-fatal myocardial
infarctions, but also occasionally soft events such as angina or
revascularizations for progressive coronary artery disease.
About RVX-208
RVX-208 is a first-in-class small molecule that inhibits BET
bromodomains. RVX-208 functions by removing atherosclerotic plaque via
reverse cholesterol transport (RCT), the natural process through which
atherosclerotic plaque is transported out of the arteries and removed
from the body by the liver. RVX-208 increases production of
Apolipoprotein A-I (ApoA-I), the key building block of functional high-density lipoprotein (HDL) particles and the type required for
RCT. These newly produced, functional HDL particles are flat and empty,
and can efficiently remove plaque and stabilize or reverse
atherosclerotic disease. Analysis of recent clinical trials data showed
that RVX-208 significantly reduces coronary atherosclerosis and major
adverse cardiac events in patients with CVD (cardiovascular disease) who have a low level of HDL
and elevated CRP, a population with unmet medical need. ApoA-I may also
exert beneficial effects in Alzheimer's disease and diabetes mellitus.
We seek Safe Harbor.
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