The pulse of heart treatment

Nile Therapeutics to collaborate with Medtronic on clinical development of cenderitide for heart failure and renal disease

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SAN MATEO, Calif.—Nile Therapeutics Inc. has announced acollaboration with medical device giant Medtronic Inc. on a peptide to treatheart failure and renal disease.
While specific financial terms of the collaboration have notbeen revealed, Minneapolis-based Medtronic is funding and will providedrug-device expertise as Nile Therapeutics works on a Phase I clinical trialfor a peptide called cenderitide.
Joshua Kazam, CEO of Nile Therapeutics, says thecollaboration will be an "important step on our path to developing cenderitideas a potential new therapy for patients with cardiovascular and renal diseasefollowing 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 Medtronicproved to be an attractive partner for this collaboration because of its statusas a leader in insulin pump technology.
"They have been in the microneedle pump business for a longtime," he says. "We think that one or more of the designs will work well withour plan for patient dosing."
The collaboration is part of a wider plan that NileTherapeutics has for cenderitide. Cenderitide is a dual natriuretic peptidereceptor agonist. Agonizing these receptors creates intracellular cGMP, whichhas vasodilating, natriuretic, diuretic, lusitropic and antifibrotic effects,depending on cell types.
Nile Therapeutics says it recently had a productive meetingwith the U.S. Food and Drug Administration (FDA) on the development ofcenderitide as an extended subcutaneous therapy for a post-acute indication.The company has received FDA fast-track approval designation. Before the end ofthe second quarter, Nile plans to file a new Investigational New Drugapplication and to initiate a Phase I PK/PD clinical trial. Following the PK/PDtrial, Nile intends to initiate a Phase II double-blind, placebo-controlled,dose-ranging clinical trial in post-acute heart failure patients in the firsthalf of 2012.
"Assuming operational proficiency and luck in patientenrollment, we believe that this indication could be on that market as early asthe end of 2016," Evans says.
Ultimately, Nile Therapeutics wants to develop cenderitide asan outpatient therapy, given for up to 90 days after discharge from thehospital, for people with acutely decompensated heart failure. That is whenpneumonia or heart attack, for example, triggers a change in patients withchronic but stable heart failure.
The first three months following admission to the hospitalis a critical time for heart failure patients who are known to have combinedrates of readmission and mortality as high as 50 percent during that period.Nile Therapeutics believes that the cardiac unloading and renal preservingproperties of cenderitide could have a significant benefit to patients during acritical time in their recovery from acute heart failure.
Heart failure is the fastest-growing clinical cardiacdisease in the United States, according to the American Heart Association,affecting more than 5 million Americans. More than 1 million patients in theUnited States each year are hospitalized with ADHF, an acute exacerbation ofheart failure. This hospitalization rate is almost double the rate seen 15years ago, and is the most frequent cause of hospital admission in the UnitedStates for patients older than 65.
According to Richard B. Brewer, Nile Therapeutics' executivechairman, post-acute patients need sustained cardiac and renal function supportto prevent a recurrence of their acute symptoms. He noted that in multipleclinical trials in both acute and chronic heart failure patients, short-terminfusion of cenderitide has been shown to have positive effects oncardiovascular and renal parameters.
"We believe that cenderitide has an opportunity to address atrue unmet need in heart failure, and could help reduce the overall cost ofhealthcare," Brewer says.
Brian Henry, senior director of media relations forMedtronic, says his company has other collaborations that are similar to theagreement with Nile Therapeutics. Drug delivery collaborations, he says, "arean emerging area for Medtronic."
"We have drug-delivery technology that is used to delivermedication for chronic pain and diabetes," he notes. "We also have developmentcollaborations with Alnylam in Huntington's disease, and we're evaluating ourdelivery 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 pharmacompanies in the future."

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