R&D, In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Younger recruitment for Diamyd's type 1 diabetes vaccine trial: Diamyd Medical is now recruiting type 1 diabetes patients aged 10 to 20 for the Phase III trial of the Diamyd diabetes vaccine, the firm announced Aug. 27. When Diamyd filed the IND for the trial, the lower age limit was 16 (1Pharmaceutical Approvals Monthly January 2008). FDA lowered the enrollment age in June to 10 years old, and the firm is now increasing its investment in the development program with more clinics and expanded recruitment activities. It will retain 13 of the original clinics and is aiming to add about 30 more. The vaccine, based on autoantigen GAD65, is designed to slow down autoimmune destruction of insulin-producing beta cells. It already has been shown in Phase II to preserve beta cell function for at least 21 months in patients with recent-onset type 1 diabetes. Other ongoing trials are aimed at better understanding natural production of insulin and the immunological mechanism of action of the vaccine, and studying the disease process of developing type 1 diabetes. The firm aims to gain approval for the vaccine in 2012
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R&D In Brief
Lacosamide Phase III diabetic neuropathic pain results: UCB's Phase III trial of Vimpat (lacosamide) for treatment of diabetic neuropathic pain met its primary endpoint of sustained reduction in average daily pain scores, firm announces Dec. 11. The randomized, double-blind, placebo-controlled trial in 551 patients showed that the change in the average daily pain was significantly greater with lacosamide 400 mg per day given in standard titration than placebo (p=0.0410). The trial was designed to evaluate lacosamide in two different titration schemes: a standard titration regimen in which patients reached their target dose at day 22, and a fast titration scheme in which the target dose was reached at day eight. The change in pain score with the fast titration regimen was numerically better than placebo, but not statistically significant (p=0.2902). The median time to achieve pain relief was 10 and 11 days for the lacosamide standard and fast titration regimens, respectively, compared with 31 days for placebo. The sodium channel/CRMP-2 agent is under review at FDA with a user fee goal date of July 29, 2008...