A Phase 2 clinical trial assessing Mesoblast's (NASDAQ:MESO) allogeneic cell therapy candidate MPC-300-IV in patients with rheumatoid arthritis (RA) who have not responded to anti-Tumor Necrosis Factor (TNF) therapy [e.g., AbbVie's Humira (adalimumab)] showed a durable improvement in symptoms, physical function and disease activity with no safety signals observed.
The study enrolled 48 patients with active RA who were on a stable regimen of methotrexate and had an inadequate response to at least one anti-TNF agent. 63% (n=30/48) has received 1 - 2 biologic agents. Participants were randomized to receive a single infusion of 1MMesenchymal Precursor Cells(MPCs)/kg (n=16), 2M MPCs/kg (n=16) or placebo (n=16). The primary study period was 12 weeks and the total study duration was 52 weeks.
Both doses of MPC-300-IV outperformed placebo at both week 12 and week 39 as measured by ACR20/50/70 (ACR20 = 20% improvement in RA symptoms). The 2M-cell cohort showed the greatest response. At week 12, for example, 27% of the 2M-cell group achieved ACR70 compared to 0% for placebo. The proportion was 36% in the subgroup (n=11) who had received 1 - 2 biologics. The treatment effect was maintained through week 39.
The clinical development of MPC-300-IV is ongoing.
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Mesoblast's cell therapy candidate MPC-300-IV shows positive treatment effect in mid-stage study in treatment ... - Seeking Alpha
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