Corthera Inc.
announced that an interim analysis of top-line data from Pre-RELAX-AHF, the
Phase II portion of a Phase II/III multicenter, randomized, double-blind,
international study, showed favorable efficacy and safety for relaxin, the
company's investigational drug for treatment of acute heart failure.
The interim Phase II results were presented by John R. Teerlink, M.D.,
Professor of Medicine, University of California San Francisco, in a
satellite symposium at the American Heart Association's (AHA) Scientific
Sessions 2008 in New Orleans. The data from the first 209 patients enrolled
in the trial demonstrated beneficial trends in acute heart failure (AHF)
signs, symptoms and outcomes with no evidence of renal toxicity. Relaxin
appeared safe and well-tolerated over a wide dose range.
"The data indicate that relaxin is a very promising treatment for AHF,"
said Teerlink, co-principal investigator of the study. "Compared to
placebo, relaxin's effect on the important endpoint of relieving dyspnea,
breathlessness, was apparent within 6 hours after start of treatment. These
initial effects lasted up to 14 days after treatment, something not
previously seen with other therapies for AHF. Relaxin's safety profile in
the study's patient population was benign during and following drug
treatment, while blood pressure effects were predictable and manageable.
There were also encouraging trends in other in-hospital endpoints,
including weight-loss due to diuresis, incidence of worsening heart failure
and length of hospital stay. The consistency of these improvements across
multiple measures of outcomes is very encouraging."
Corthera's Pre-RELAX-AHF/RELAX-AHF study is a Phase II/III,
multicenter, randomized, double-blind, placebo-controlled, parallel-group,
international trial designed to evaluate the efficacy and safety of relaxin
for the treatment of AHF. In the Phase II Pre-RELAX-AHF study, the
objective was proof-of-concept and dose and endpoint selection. In Phase
III RELAX-AHF, the objective is to confirm safety and efficacy. Patients
selected for the study presented to the hospital with dyspnea
(breathlessness) due to AHF and with elevated blood pressure and renal
dysfunction. The Pre-RELAX-AHF/RELAX-AHF study was designed and conducted
in collaboration with Momentum Research, headed by Dr. Gad Cotter.
Marco Metra, M.D., Professor of Cardiology at the University of
Brescia, Italy, and co-principal investigator of the Pre-RELAX-AHF study,
was also a speaker at the symposium. "Patients with AHF remain a major
clinical challenge with extremely high morbidity and mortality rates.
Promising new agents such as relaxin are needed to treat these patients and
improve their outcomes. The data from the Phase II study met the objectives
of the proof-of-concept Pre-RELAX-AHF study, allowing the selection of the
appropriate dose and endpoints for further study. Progression to the Phase
III portion of the study is now clearly warranted," said Dr. Metra.
According to the AHA, heart failure is a costly syndrome contributing
to more than three million hospitalizations each year in the U.S. The great
majority of patients with acute heart failure have fluid accumulation in
the lungs (congestion) that causes shortness of breath (dyspnea) and other
complications. For these patients, the current standard of care includes
diuretics and vasodilators. Both of these classes of agents have been
associated with renal impairment, hypotension and adverse outcomes.
About Relaxin
Relaxin is a naturally occurring peptide hormone that acts as a
systemic and renal vasodilator. Elevated levels of relaxin modulate
increases in renal and cardiac function that meet the increased hemodynamic
demands of pregnancy. Consistent with this natural role of the hormone,
pharmaceutically manufactured relaxin has been shown to have these effects
in multiple human studies of men and non-pregnant women. Data from the
Pre-RELAX study, as well as a pilot study in patients with heart failure,
support the expectation that these effects may be beneficial in relieving
the signs and symptoms of heart failure.
About Corthera
Corthera Inc. is a biopharmaceutical company committed to acquiring,
developing and commercializing therapies for illnesses in the acute care
setting. Corthera's lead product candidate, relaxin, is currently being
evaluated in clinical trials for acute heart failure. Corthera has
worldwide rights to develop and commercialize relaxin.
About Momentum Research
Momentum Research, Inc. is a consulting and management organization
with clinical expertise and leadership dedicated to the development of
cardiovascular products and studies. For more information go to
momentum-research
Corthera Inc.
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