Column 1 0 Mesoblast Ltd (MESO - NASDAQ - $6.04 ) 1 Buy 2 Target Price: $18.00 Faster Than We Thought – Pivotal Trial Being Shortened
Following FDA Discussions: Company May Have POC Data
Column 1 0 Summary: 1
- The ongoing phase 3 program will be revised (based on a review of the data and powering assumptions) as follows:
- The FDA has agreed to a reduction in the current phase 3 trial size from 1,165 to approximately 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 vs. control;
- 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 the phase 2 trial; and
- A second confirmatory study will be conducted in parallel in an identical patient population of approximately 600 subjects using the same primary endpoint.
- Conclusion. We have not factored in this shorter timeline to the marketplace. As a result, our estimates may be too conservative.
2 Details: 3 Recall the following:
· The P3 trial enrollment criteria have been enriched by enrolling patients who have had an HF-related hospitalization in the past nine months and high baseline NT-proBNP levels (these patients typically have large baseline LVESV and high rates of HF-MACE).
· The P3 trial originally was going to use an ent analysis of heart failure-related major adverse cardiovascular events (HF-MACE) as the primary endpoint. Based on the prior P2 data, patients have a greater probability of remaining free of heart failure-related major adverse cardiovascular events (HF-MACE) vs. control (0% vs. 33%, p=0.026 by log-rank). This allowed Mesoblast to reduce the target enrollment from 1,730 to 1,165 without any sacrifice of power. The change just announced allows the power to now come down to n=600.
· We know that an interim analysis had been planned in the ongoing phase 3 trial when 50% of the HF-MACE have occurred, which will include a test for superiority allowing for the possibility of stopping the trial early based on overwhelming efficacy. We have to review how this may be revised.
· A second, confirmatory study is planned to be conducted in parallel in an identical patient population of approximately 600 subjects using recurrent HF-MACE as the primary endpoint. The use of recurrent HF-MACE as a primary endpoint is supported by the P2 trial (again) where the MPC-150-IM patients had no HF-MACE over 36 months versus 11 recurrent HF-MACE in the control group (p<0.001, log rank test).
Conclusion. We view these revisions as very positive, as the interim analysis at 50% HF-MACE events will test for superiority. If that happens, we could see a fast-track pathway to the global marketplace emerge.
Valuation. Our 12-month price target for Mesoblast is based on three metrics, free-cash-flow (FCF), discounted-EPS, and sum-of-the-parts (SOP) models, equally weighted, which point to an $18.00 price target.
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