Daiichi Sankyo Announces Positive Top-line Results from Phase 3 Clinical Trial Evaluating Mirogabali

Daiichi Sankyo announced positive top-line results from REDUCER (an Asian, phase 3, multicenter, RandomizEd, Double-blind, placebo-controlled 14-week stUdy of mirogabalin in patients with diabetiC pEripheral neuRopathic pain, followed by a 52-week open-label extension).

In the REDUCER clinical trial, mirogabalin demonstrated statistically significant reduction compared to placebo in the primary endpoint, change in weekly average daily pain score (ADPS) from baseline to Week 14. Preliminary and ongoing analyses indicated no significant safety concerns in the REDUCER trial. The REDUCER trial was followed by a 52-week open-label extension at approximately 200 centers in Japan, Taiwan, China, South Korea and Malaysia.

"The top-line results from the REDUCER trial provide us with important data on the clinical profile of mirogabalin in patients with diabetic peripheral neuropathic pain," said Marielle Cohard-Radice, MD, Executive Vice President, Global Head of Development, Daiichi Sankyo, Inc. "These results, along with the positive data from the NEUCOURSE trial in post-herpetic neuralgia, support mirogabalin's potential use in specific pain syndromes and our path forward for bringing this innovative medicine to patients who need relief from pain."

The primary objective of the 14-week REDUCER trial was to evaluate the efficacy of mirogabalin by comparing the change in the ADPS from baseline to Week 14 in patients receiving 10 mg or 15 mg of mirogabalin twice-daily versus placebo. Weekly ADPS is based on daily pain scores reported by the patient that best describes his or her pain over the previous 24 hours. Secondary objectives in the REDUCER trial included a comparison of the change in ADPS from baseline to Week 14 in patients receiving mirogabalin 15 mg once-daily versus placebo, as well as a comparison of the proportion of patients by treatment group with greater than or equal to 30 and 50 reductions in ADPS from baseline to Week 14.

The REDUCER trial is an integral component of Daiichi Sankyo's global clinical development program for mirogabalin in neuropathic pain, also inclusive of the NEUCOURSE trial. Top-line results from the NEUCOURSE trial were announced in June 2017. Further results from the REDUCER trial will be disclosed in upcoming scientific forums.