Cenderitide

Cenderitide Phase II

Cenderitide

In 2015, a Phase II study was completed in 14 patients with stable, chronic heart failure. Patients received up to eight consecutive days of Cenderitide through subcutaneous infusion using Insulet’s drug delivery system based on the OmniPod technology. This open-label trial assessed the safety, tolerability, pharmacokinetic profiles and pharmacodynamic response to increasing dose levels of Cenderitide administered in a stepwise fashion. The drug was well-tolerated and there were no significant adverse events. Capricor has recently completed an additional study to further assess the safety, tolerability, pharmacokinetic profiles and pharmacodynamic response to increasing dose levels of Cenderitide in patients with stable heart failure with moderate renal impairment.


Status of Studies:

Enrollment Complete.

Previous Clinical Results:

A pharmacokinetic/pharmacodynamic (PK/PD) in 58 patients with chronic heart failure was conducted to determine the doses required to achieve pre-determined plasma levels of Cenderitide when delivered through subcutaneous pump technology of Medtronic, Inc. The top line results included:

  • Primary end-point was met: Cenderitide achieved target PK levels when delivered through Medtronic’s subcutaneous pump technology
  • Delivery method well-tolerated: 24-hour subcutaneous delivery of Cenderitide through Medtronic’s pump technology was well-tolerated, with no injection site irritation
  • Absorption: subcutaneously delivered Cenderitide has an acceptable bioavailability profile
  • Delivery Method: Cenderitide’s PK profile achieved steady-state when delivered through subcutaneous infusion
  • Dosing: weight-based dosing reduced PK variability, as compared to a fixed dosing regimen

Prior to the Phase I PK/PD subcutaneous clinical trial, four intravenous (IV) clinical trials were successfully completed, including a Phase II clinical trial in 77 hospitalized patients with Acute Decompensated Heart Failure (ADHF). In the Phase II trial, IV Cenderitide or placebo was administered to ADHF patients with mild to moderate renal function for up to 72 hours. The primary endpoint of the trial was safety and tolerability. Secondary endpoints included several measures of drug activity, including renal biomarkers.

Results from the previous Phase II trial showed:

  • 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 that correlated with kidney function

Data from the previous Phase II trial were presented at the American College of Cardiology (ACC) conference in April 2011.


More Information:

Please visit Clinicaltrials.gov (NCT02603614) for more information on the current Phase II study.

Please visit Clinicaltrials.gov (NCT02359227) for more information on the recently completed Phase II study.

Please visit Clinicaltrials.gov (NCT01316432) for more information on the completed Cenderitide PK/PD study.