Dipraglurant-IR: Phase IIa data
Top-line data from a double-blind, placebo-controlled, international Phase IIa trial in 76 patients with moderate to severe PD-LID showed that oral dipraglurant-IR plus levodopa was well tolerated and met the primary safety endpoint with no changes in liver function tests reported. Additionally, the incidence of adverse events was similar in patients receiving dipraglurant and placebo (88.5% vs. 75%). On exploratory endpoints, dipraglurant significantly reduced peak mAIMS scores on day 1 and on day 14 vs. placebo (p=0.042 and p=0.038, respectively). Addex said dipraglurant achieved the targeted effect of either a 30% reduction from baseline in mAIMS score or a 20% reduction vs. placebo on days 1, 14 and 28. Additionally, dipraglurant significantly reduced the area under the curve (AUC) of mAIMS scores over the 3-hour post-levodopa dosing period from baseline by about 30% at days 14 (p=0.042) and 28 (not significant). ...