Daiichi Sankyo reports top-line results from Phase III trials of mirogabalin
Japanese pharmaceutical firm Daiichi Sankyo has reported top-line results from its Phase III NEUCOURSE and ALDAY clinical trials of mirogabalin to treat post-herpetic neuralgia and fibromyalgia.
Mirogabalin is an oral therapeutic candidate that selectively binds to the alpha-2 delta-1 (α2δ-1) subunit of calcium channels in nervous system areas that are involved in pain transmission and processing.
The NEUCOURSE trial met the primary efficacy endpoint of decreasing the weekly average daily pain score (ADPS) from baseline to week 14, while the ALDAY clinical trials did not meet the endpoint of a decrease in the weekly ADPS score by week 13.
The Phase III NEUCOURSE trial assessed twice-daily 10mg and 15mg mirogabalin doses in 765 Asian subjects with post-herpetic neuralgia over a 14-week period.
The trial took place at 200 sites across Japan, Taiwan, Korea, Singapore, Malaysia and Thailand.
A one-year, open-label extension phase was conducted in subjects who completed the double-blind phase to investigate the therapeutic candidate’s long-term safety and efficacy.
Daiichi Sankyo executive vice-president and Development global head Marielle Cohard-Radice said: “Daiichi Sankyo is committed to bringing innovative medicines to patients who need relief from pain, and we will continue to study mirogabalin and its potential use in pain syndromes as part of our ongoing global clinical development programme.”
The ALDAY clinical programme included three identical Phase III trials that investigated once-a-day and twice daily 15mg mirogabalin in more than 3,600 patients with fibromyalgia over 13 weeks.
The trials were performed at 300 centres across North and South America, Eastern and Western Europe, and the Asia Pacific.
Analyses of both the NEUCOURSE and ALDAY trials indicated no unexpected safety concerns.