ASN meeting highlights Otsuka's tolvaptan' Alexion's Solaris and Roche's aleglitazar research

Japan’s Otsuka Pharmaceutical (TYO: 4768) that the clinical trial results for tolvaptan, an investigational drug for the treatment of compound for autosomal Dominant polycystic kidney disease ADPKD, were presented for the first time at the American Society of Nephrology (ASN) annual meeting, which took place over past the weekend, and simultaneously published on-line in the New England Journal of Medicine.

Tolvaptan met its primary endpoint of demonstrating a statistically significant (p<0.001) reduction (nearly 50% reduction) in the rate of increase in total kidney volume (TKV) over the three-year study period as compared to placebo among patients with ADPKD. These findings are from the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3:4 Study, a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial involving more than 1,400 patients.

Trial results were presented by Vicente Torres, professor of medicine, Division of Nephrology and Hypertension, Mayo Clinic, said: "In most patients with this disease, relentless cyst growth within the kidneys destroys the tissue, causes hypertension and painful complications, and negatively impacts the quality of life. The results of this study reveal a potential treatment that blunts kidney growth, lessens associated symptoms and slows kidney function decline when given over three years."