Conatus Pharmaceuticals Inc.
CNAT today announced that its late-breaking abstract was accepted for
a poster presentation at The Liver Meeting®, the annual meeting of the
American Association for the Study of Liver Diseases (AASLD) in Boston,
November 7-11, 2014. The poster, entitled "Rapid and statistically significant
reduction of markers of apoptosis and cell death in subjects with mild,
moderate and severe hepatic impairment treated with a single dose of the
pan-caspase inhibitor, emricasan," will be presented on Monday, November 10,
2014. The abstract is available at www.aasld.org/.
In the abstract, Conatus disclosed that its lead drug candidate, the orally
active pan-caspase protease inhibitor emricasan, reduced key biomarkers in a
recently completed, single-dose, pharmacokinetic (PK)/pharmacodynamic (PD)
Phase 1 clinical trial in subjects with mild, moderate or severe hepatic
impairment (defined using the Child-Pugh criteria). Emricasan was administered
to 28 subjects with hepatic impairment and 8 matched control subjects, and
serial blood samples were collected over a 48 hour period. Levels of three key
biomarkers of apoptosis (caspase-cleaved cytokeratin 18), cell death
(full-length cytokeratin 18), and caspase enzymatic activity (caspase 3/7)
were elevated at study baseline correlating to disease severity, and
demonstrated rapid and statistically significant reductions after a single 50
mg oral dose of emricasan in all hepatic impairment subjects.
"We are encouraged by emricasan's ability to reduce key disease-elevated
biomarkers of caspase activity, apoptosis and cell death rapidly after even a
single dose," said Conatus President and Chief Executive Officer, Steven J.
Mento, Ph.D. "Our ongoing Phase 2 trials in patients across a broad spectrum
of liver disease are designed to assess whether reductions of these potential
drivers of liver disease progression result in corresponding clinical
benefit."
The company is conducting three clinical trials investigating the PK and PD
activity of emricasan in patients with impaired organ function to support dose
selection and prioritization for advancement in its overall clinical
development program: the Phase 1 clinical trial in patients with various
degrees of hepatic impairment described above; a Phase 1 clinical trial in
patients with severe renal impairment; and a Phase 2b clinical trial in
patients with acute-on-chronic liver failure (ACLF) who may have simultaneous
impairment of both liver and kidney function as well as other organ
involvement. Preliminary PK data from the Phase 1 hepatic impairment trial and
Phase 1 severe renal impairment trial were sufficient to identify the
appropriate patients for inclusion in a recently initiated Phase 2 clinical
trial in patients with liver cirrhosis. Since patients with variable degrees
of liver and kidney function are expected to be assessed in future clinical
trials, final PK data from all three of the above clinical trials will be
evaluated in the aggregate after completion of the ACLF trial, and are
expected to inform on optimal dosing of emricasan in future studies in
potential target patient populations.
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