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# Mesoblast, FDA Agree on Smaller Phase 3 Trial
- URL: https://www.fdaweb.com/mesoblast-fda-agree-on-smaller-phase-3-trial/
- Published: 2016-01-11T12:00:00.000Z
- Updated: 2026-09-15T02:26:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134392

> Mesoblast Ltd. says FDA has agreed to a smaller patient enrollment target for a Phase 3 trial involving MPC-150-IM in chronic heart failure (CHF), which should shorten the time to trial completion. The agreement follows a meeting last month between Mesoblast’s development and commercial partner, Teva Pharmaceutical Industries, and FDA that proposes a change in the trial’s primary endpoint.  
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> According to Mesoblast, the ongoing Phase 3 program is planned to be optimized as follows:FDA has agreed to a reduction in the current Phase 3 trial size from 1,165 to about 600 patients due to a proposed change in the primary endpoint The revised primary endpoint will be a comparison of recurrent heart failure-related major adverse cardiovascular events (HF-MACE) between patients treated with MPC-150-IM and controls The proposed use of recurrent HF-MACE as a primary endpoint in the Phase 3 trial is based on the fact that a single injection of MPC-150-IM successfully prevented recurrent HF-MACE over three years in a Phase 2 trialA second confirmatory study will be conducted in parallel in an identical patient population of about 600 subjects using the same primary endpoint.  
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> The company notes that in the completed Phase 2 trial, patients treated with MPC-150-IM had no HF-MACE over 36 months of follow-up, compared with 11 HF-MACE events in the control group. “In patients with advanced heart failure as defined by baseline Left Ventricular Systolic Volume >100ml, who closely resemble the patients being recruited in the Phase 3 trial, 71% of controls had at least one HF-MACE event vs 0 of those who received a single injection of MPC-150-IM (p<0.001),” it says.