Mesoblast (ASX: MSB, MESO) P2 Trial Results in Diabetic Kidney Disease Published

October 6, 2016 7:19am

Safety profile for MPC-300-IV treatment was similar to placebo, with no treatment-related adverse events. Efficacy testing showed that patients receiving a single MPC infusion at either dose had improved renal function relative to placebo, as defined by preservation or improvement in GFR at 12 weeks.

Results from the randomized, placebo-controlled P2 trial of its proprietary allogeneic Mesenchymal Precursor Cell (MPC) product candidate, MPC-300-IV, in patients with diabetic kidney disease have been published in the current issue of the peer-reviewed journal EBioMedicine.

The paper, entitled ‘Allogeneic Mesenchymal Precursor Cells (MPC) in Diabetic Nephropathy: A Randomized, Placebo Controlled, Dose Escalation Study’, concluded that a single intravenous infusion of MPC-300-IV was well tolerated and had positive effects on renal function at the 12-week primary endpoint in a P2 trial in adult patients with type 2 diabetic nephropathy.

• The study was conducted by researchers at the University of Melbourne, Epworth Medical Centre and Monash Medical Centre in Australia.

The P2, double-blind, randomized, placebo-controlled, dose-escalating trial evaluated MPC-300-IV in patients with type 2 diabetes and moderate to severe renal impairment, stage 3b-4 chronic kidney disease (CKD), who were already on a stable regimen of the standard of care therapy for diabetic nephropathy (renin-angiotensin system inhibition with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers). A total of 30 patients were randomized to receive a single infusion of 150 million MPCs, 300 million MPCs, or saline control on top of maximal therapy.

The Bottom Line: The efficacy signal observed with respect to preservation or improvement in GFR is exciting, especially given that this trial was not powered to show statistical significance. Patients receiving a single infusion of MPC-300-IV showed no evidence of developing an immune response to the administered cells, suggesting that repeat administration is feasible and may in the longer term be able to halt or even reverse progressive chronic kidney disease. P3 clinical trial NEEDED to test as soon as possible for ... validation of "claims".

MESO closed at $4.29 which was UP +$0.03. Results are not earth shattering but, definitely a need for a P3.

Still a BUY

Diabetic nephropathy is the single leading cause of end-stage kidney disease, accounting for nearly half of all end-stage kidney disease cases in the United States and over 40% of new patients entering dialysis treatment. There were almost 2 million cases of moderate to severe diabetic nephropathy in 2013.  Diabetic nephropathy occurs even when glucose levels are well controlled, and is thought to be due to chronic infiltration of the kidneys by inflammatory monocytes which secrete pro-inflammatory cytokines resulting in endothelial dysfunction and fibrosis.