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CD-NP, which is in Phase 2 clinical studies for an initial indication of acute decompensated heart failure (ADHF), belongs to a class of drugs called natriuretic peptides. Within the human body there are two natriuretic peptide receptor (NPR) sub-types primarily responsible for biological activity: NPR-A and NPR-B. Two NPR-A receptor agonists are on the market, Natrecor® in the US and hANP® in Japan.
Current therapies for ADHF, including diuretics (Lasix®), blood vessel dilators (nitroglycerin and Natrecor®), and inotropic agents (dobutamine), have been shown to deliver beneficial pharmacological effects, but have also been associated with certain potentially life-threatening side effects including:
- Hypotension (low blood pressure), and
- Decreased renal function
CD-NP, which acts on both the NPR-A and NPR-B receptors, was designed by scientists at the Mayo Clinic's cardio-renal research laboratory to relieve ADHF symptoms without excessive systemic blood pressure reduction, while also enhancing or preserving renal function. Clinical results to-date have demonstrated that CD-NP 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
CD-NP - A New Solution and a Unique Opportunity
CD-NP's safety and efficacy profile to-date present a promising opportunity to address the significant unmet need that currently exists in the treatment of ADHF. Specific advantages include:
- Clinical evidence of positive diuretic, cardiac and renal benefits, with minimal impact on blood pressure.
- Clear regulatory approval pathway.
- Potential to address multiple indications including chronic heart failure, acute myocardial infarction and renal protection during CABG.
CD-NP - Clinical Results
To-date, Nile has successfully completed three clinical trials of CD-NP. Whereas current therapies for ADHF have been associated with certain life-threatening side effects including decreased renal function and low blood pressure, study findings have shown CD-NP to possess an impressive safety profile.
In fact, Nile's clinical results to date have demonstrated that CD-NP may offer the diuretic and cardiac benefits necessary to effectively treat ADHF while preserving renal function and beneficially managing blood pressure. Findings from Nile's completed clinical studies have shown the following:
CD-NP - Ongoing Phase 2 Clinical Trial
CD-NP is currently being evaluated in a Phase 2 trial in ~75 ADHF patients. CD-NP is being administered for up to 72 hours on top of the standard of care in patients who have been admitted to the hospital for ADHF. Interim top-line results suggest that CD-NP is well-tolerated at dose levels of 1.25 and 2.5 ng/kg/min. Full results are expected for this trial in late 2010.
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