Mesoblast (ASX:MSB; USOTC: MBLTY) has announced that Phase 2 trial results of its lead product candidate for the treatment of diabetic nephropathy have been selected for presentation at the late-breaking scientific sessions of the 75th American Diabetes Association (ADA) Scientific Sessions in June.
The annual meeting, which is being held in Boston, is the largest diabetes meeting in the world, bringing together approximately 14,000 participants, including clinicians and researchers from 124 countries.
Mesoblast is developing its allogeneic mesenchymal precursor cell (MPC) product candidate, MPC-300-IV, for intravenous delivery in the treatment of specific conditions caused by excessive inflammation and endothelial dysfunction, including biologic-refractory rheumatoid arthritis and diabetic nephropathy.
According to the company, by down-regulating pro-inflammatory cytokines produced by monocytes and T cells, MPCs may counteract the destructive inflammatory processes and vascular dysfunction implicated in these diseases.
"As many as 40-50% of people with type 2 diabetes develop progressive decline in renal function due to nephropathy (or kidney disease), despite use of existing therapies," it said. "These patients have a high rate of progression to dialysis and death due to cardiovascular events. Abnormal chronic inflammation and microvascular dysfunction which persist in the diabetic kidney over many years are thought to be important causal factors in the development of progressive diabetic nephropathy."
It continued, "To establish an MPC dose range that is safe and effective for use in diabetic patients, Mesoblast initially performed a randomised, placebo-controlled, dose-escalating Phase 2 trial in patients with type 2 diabetes, insulin resistance and poor glycemic control, but without kidney disease.
"In that trial, a single infusion of allogeneic MPCs resulted in a dose-dependent improvement in hemoglobin A1c levels (HbA1c), the recommended primary endpoint by the FDA for glycemic control in diabetic patients. The greatest decrease relative to placebo was seen at eight weeks following a single dose of 2 million MPCs/kg or a total dose of at least 150 million MPCs (p<0.05).
"Using results from this dose-ranging study as a guide, Mesoblast conducted a double-blind, randomised, placebo-controlled, dose-escalating Phase 2 trial in 30 patients with type 2 diabetes and moderate to severe renal impairment, stage 3b-4 chronic kidney disease."
The company said the objectives of the trial were to evaluate safety and tolerability of a single infusion of 150 or 300 million MPCs in patients with diabetic nephropathy, and to explore potential efficacy signals in terms of renal function and biomarkers of inflammation at 12 weeks, with ongoing follow-up for an additional 48 week period.
Initial results for this trial will be presented by the trial's principal investigator at the upcoming ADA meeting.