Daiichi Sankyo reported mixed results from the Phase III NEUCOURSE and ALDAY clinical trials with its oral pain management candidate mirogabalin. The 14-week, placebo-controlled NEUCOURSE study in Asian patients with post-herpetic neuralgia met its primary endpoint and demonstrated that treatment using one or two doses of mirogabalin twice daily resulted in statistically significant reductions in the weekly average daily pain score (ADPS). The NEUCOURSE study involved 765 patients aged 20 years and older in Japan, Taiwan, Korea, Singapore, Malaysia, and Thailand. The double-blind phase of the study was followed by a one-year, open-label extension.

In contrast, three 13-week ALDAY trials assessing mirogabalin in the treatment of pain associated with fibromyalgia failed to meet their primary efficacy endpoint of statistically significant reductions from baseline in the weekly average of worst daily pain score. The three identical global ALDAY studies evaluated mirogabalin in over 3600 patients aged 18 years and over.  A separate one-year, open-label study involving about 2000 patients, including newly enrolled participants and patients from ALDAY, has also been completed. 

“The NEUCOURSE and ALDAY results provide us with important data and insights regarding the clinical profile of mirogabalin in specific pain populations,” said Marielle Cohard-Radice, M.D., Daiichi Sankyo evp and global head of development. “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 program.”

The NEUCOURSE and ALDAY trials are part of Daiichi Sankyo’s broad clinical program evaluating mirogabalin in pain syndromes, including diabetic peripheral neuropathic pain.

Mirogabain is an oral therapy designed to bind to the α2δ-1 (alpha-2 delta-1) subunit on calcium channels in areas of the nervous system that mediate pain transmission and processing. Daichii Sankyo’s global Phase III clinical program for mirogabalin comprises multiple Phase III studies, including the REDUCER study in diabetic peripheral neuropathic pain.

In March, Daiichi Sankyo and Heptares Therapeutics reported a drug discovery and licensing deal worth $12 million in upfront and research funding to develop small-molecule drug candidates targeting G protein-coupled receptors (GPCRs) for potential applications in pain relief.  

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