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The pulse of heart treatment
SAN MATEO, Calif.—Nile Therapeutics Inc. has announced a collaboration with medical device giant Medtronic Inc. on a peptide to treat heart failure and renal disease.
While specific financial terms of the collaboration have not been revealed, Minneapolis-based Medtronic is funding and will provide drug-device expertise as Nile Therapeutics works on a Phase I clinical trial for a peptide called cenderitide.
Joshua Kazam, CEO of Nile Therapeutics, says the collaboration will be an "important step on our path to developing cenderitide as a potential new therapy for patients with cardiovascular and renal disease following hospitalization for acute heart failure."
This is the first time the companies have worked together, but Daron Evans, chief financial officer for Nile Therapeutics, says Medtronic proved to be an attractive partner for this collaboration because of its status as a leader in insulin pump technology.
"They have been in the microneedle pump business for a long time," he says. "We think that one or more of the designs will work well with our plan for patient dosing."
The collaboration is part of a wider plan that Nile Therapeutics has for cenderitide. Cenderitide is a dual natriuretic peptide receptor agonist. Agonizing these receptors creates intracellular cGMP, which has vasodilating, natriuretic, diuretic, lusitropic and antifibrotic effects, depending on cell types.
Nile Therapeutics says it recently had a productive meeting with the U.S. Food and Drug Administration (FDA) on the development of cenderitide as an extended subcutaneous therapy for a post-acute indication. The company has received FDA fast-track approval designation. Before the end of the second quarter, Nile plans to file a new Investigational New Drug application and to initiate a Phase I PK/PD clinical trial. Following the PK/PD trial, Nile intends to initiate a Phase II double-blind, placebo-controlled, dose-ranging clinical trial in post- acute heart failure patients in the first half of 2012.
"Assuming operational proficiency and luck in patient enrollment, we believe that this indication could be on that market as early as the end of 2016," Evans says.
Ultimately, Nile Therapeutics wants to develop cenderitide as an outpatient therapy, given for up to 90 days after discharge from the hospital, for people with acutely decompensated heart failure. That is when pneumonia or heart attack, for example, triggers a change in patients with chronic but stable heart failure.
The first three months following admission to the hospital is a critical time for heart failure patients who are known to have combined rates of readmission and mortality as high as 50 percent during that period. Nile Therapeutics believes that the cardiac unloading and renal preserving properties of cenderitide could have a significant benefit to patients during a critical time in their recovery from acute heart failure.
Heart failure is the fastest-growing clinical cardiac disease in the United States, according to the American Heart Association, affecting more than 5 million Americans. More than 1 million patients in the United States each year are hospitalized with ADHF, an acute exacerbation of heart failure. This hospitalization rate is almost double the rate seen 15 years ago, and is the most frequent cause of hospital admission in the United States for patients older than 65.
According to Richard B. Brewer, Nile Therapeutics' executive chairman, post-acute patients need sustained cardiac and renal function support to prevent a recurrence of their acute symptoms. He noted that in multiple clinical trials in both acute and chronic heart failure patients, short-term infusion of cenderitide has been shown to have positive effects on cardiovascular and renal parameters.
"We believe that cenderitide has an opportunity to address a true unmet need in heart failure, and could help reduce the overall cost of healthcare," Brewer says.
Brian Henry, senior director of media relations for Medtronic, says his company has other collaborations that are similar to the agreement with Nile Therapeutics. Drug delivery collaborations, he says, "are an emerging area for Medtronic."
"We have drug-delivery technology that is used to deliver medication for chronic pain and diabetes," he notes. "We also have development collaborations with Alnylam in Huntington's disease, and we're evaluating our delivery technology for use in other diseases such as hepatitis C and Alzheimer's. We believe we're well-positioned to be a partner to biotech and pharma companies in the future."