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Cenderitide belongs to a class of drugs called natriuretic peptides. Preclinical and clinical data have shown that the natriuretic peptide class can act on multiple disease processes that play a role in the negative outcomes associated with heart failure. Two natriuretic peptides are currently on the market, Natrecor® in the US and hANP® in Japan, both approved to treat acutely decompensated heart failure (ADHF).
Cenderitide was designed by scientists at the Mayo Clinic to be the only dual natriuretic peptide receptor agonist. This differentiated mechanism of action may provide a unique therapeutic window to relieve symptoms of heart failure. Clinical results to-date have demonstrated that cenderitide may represent a superior treatment solution by offering the following therapeutic benefits:
- Reduction in cardiac pressure;
- Improved diuresis;
- Preservation/enhancement of renal function; and
- Managed blood pressure reduction
Post Acute Indication
Cenderitide is being developed as an outpatient therapy for patients to be taken continuously for 90 days following admission for ADHF, the "post-acute" period.
There are over 1.2 million admissions for ADHF per year in the United States according to the American Heart Association. Within 90 days following admission for ADHF (the post-acute period), approximately 40% of patients return to the hospital. Post-acute patients need sustained cardiac and renal function support to prevent a recurrence of their acute symptoms.
In multiple clinical trials in both acute and chronic heart failure patients, a short-term infusion of cenderitide has been shown to have positive effects on cardiovascular and renal parameters. Nile believes that the continuous and extended infusion of cenderitide through a subcutaneous pump will provide patients with sustained symptomatic relief in the outpatient setting that could contribute to a reduction in post-acute hospitalizations and persistent improvement in cardio-renal functions.
Cenderitide is expected to improve 90 day post-acute re-hospitalization through:
- Prolonged reduction of wedge pressure and blood pressure
- Additional diuretic and natriuretic effects on top of standard oral diuretics
- Improved medication compliance with a continuous subcutaneous pump delivery
- Possible prevention of the progression of maladaptive ventricular hypertrophy
- Suppression of cardiac fibroblast proliferation and a reduction in scarring
Clinical Results
To-date, Nile has successfully completed four clinical trials of cenderitide. Findings from Nile's completed clinical studies have shown the following:
Additionally, top line from a recently completed trial of cenderitide in ADHF patients showed that:
- IV infusion at 1.25, 2.5 and 3.75 ng/kg/min appeared to be well tolerated with a dose-dependent effect on blood pressure
- Dose escalation was limited by significant blood pressure reduction at 5 ng/kg/min
- Lower doses of cenderitide appeared to preserve or enhance renal function compared to placebo, as evidenced by favorable trends in several biomarkers correlated with kidney function, including creatinine and cystatin-c
Data will be presented at the American College of Cardiology conference in early April.
Clinical Development Plan
In the second quarter of 2011, Nile intends to initiate dosing of a Phase I clinical trial to assess the pharmacokinetics and phamacodynamics of cenderitide delivered through a subcutaneous pump. Cenderitide will be delivered to heart failure patients for up to 24 hours through continuous subcutaneous infusion. Nile expects to complete the trial by the first quarter of 2012.
Following the Phase I study, Nile intends to initiate a larger Phase II double-blind, placebo-controlled, dose ranging study in patients admitted to the hospital for ADHF. The planned Phase II study will evaluate the endpoints of cardiac remodeling, renal function, re-hospitalization and mortality in patients after 90 days of continuous cenderitide therapy via subcutaneous pump.
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