Catena idebenone: Additional Phase II data

Additional data from the double-blind, international Phase II RHODOS trial in 39 evaluable patients who had severely impaired color contrast sensitivity at baseline showed that 900 mg/day Catena significantly improved blue-yellow color contrast from baseline to week 24 vs. placebo (7.3% improvement vs. 6.4% worsening, p=0.008), but non-significantly improved red-green color contrast vs. placebo (p=0.239). Data were presented at the American Neurological Association meeting in San Francisco.

Santhera previously reported data from all 82 patients in the trial showing that Catena missed the primary endpoint of significantly improving best recovery in VA in either eye as measured by change in logMAR from baseline to week 24 vs. placebo (6 vs. 3 letter improvements, p=0.291). However, the company also said that advice obtained from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and the CHMP of the European Medicines Agency (EMA) defined conditions under which "standard interpretation of p-values may not be required to demonstrate a positive risk-benefit" (see BioCentury, June 21). ...