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Mesoblast (MESO) results from ongoing P2 trial in rheumatoid arthritis showed sustained clinical responses - BUY

February 16, 2016 7:17am

Top line results showed that a single intravenous infusion of the lower dose of MESO's proprietary Mesenchymal Precursor Cell product candidate, MPC-300-IV, was safe and resulted in early and sustained clinical responses.

The lower MPC dose was evaluated in the first cohort of 24 patients, of whom 16 had failed 1-2 biologics.

The second cohort of 24 patients, evaluating the higher dose of MPCs, is actively recruiting.

The trial's primary endpoint is safety, with pre-specified efficacy endpoints at 12 weeks including the American College of Rheumatology (ACR) 20%, 50% and 70% response criteria (ACR20/50/70).

The Bottom Line; Trial results for both cohorts are expected to be reported in Q3 2016.

Key top line results for cohort 1 were:

Cell infusions were well tolerated with no cell-related adverse events
The trial's 12 week, pre-specified ACR20 efficacy endpoint was achieved by 47% of all MPC-treated patients and by 60% of MPC-treated patients who failed 1-2 biologics, vs 25% and 17%, respectively, of matched placebo-treated controls
71% of MPC-treated patients who achieved ACR20 responses did so as early as week 1
Remission at week 12, as defined by Disease Activity Score (DAS28/CRP)

MESO closed at $4.36 - BUY

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