Eisai Co Ltd and Purdue Pharma LP will present data on their investigational sleep-wake regulation agent lemborexant (development code: E2006), in an oral presentation at the 43rd Annual Meeting of the Japanese Society of Sleep Research (JSSR), July 11-13, Sapporo, Japan. The presentation will focus on the latest lemborexant data from both clinical and non-clinical studies relating to insomnia, a sleep-wake disorder.

Eisai will present results of SUNRISE 1, a placebo-controlled, double-blind active comparator Phase 3 pivotal study of the safety and efficacy of lemborexant versus placebo and versus an active comparator (zolpidem tartrate extended release, “zolpidem ER”) in approximately 1,000 patients 55 years and older with insomnia. Topline results of SUNRISE 1 were announced earlier this year.

“With a robust polysomnography data set, SUNRISE 1 is the first-ever Phase 3 study with a direct head-to-head comparison versus zolpidem ER,” says Lynn Kramer, MD, chief clinical officer and chief medical officer, neurology business group at Eisai. “Our aspiration for lemborexant is to bring patients with sleep disorders a treatment option for sleep-wake regulation that improves their ability to fall asleep and stay asleep, without impairing them the next morning.”

SUNRISE 1 evaluated change from baseline for both sleep onset (primary objective) defined by latency to persistent sleep (LPS) and sleep maintenance variables (key secondary objectives), including the time spent awake in the second half of the night. The study used objective polysomnography (PSG) to determine if lemborexant 5 mg and 10 mg had a shorter time to sleep onset and prolonged sleep maintenance compared to the recommended dose of zolpidem ER. It also assessed the ability to maintain postural stability—a predictor of risk for falls—and cognition the next morning. In this study, lemborexant had rates of discontinuation due to adverse events comparable to placebo, and the most common AEs in the lemborexant arms were headache and somnolence.

These data build on growing clinical evidence for lemborexant, including two, key Phase 1 studies (Study 108 and Study 106) which were recently presented at the 32nd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2018) meeting.

“The ability to fall asleep quickly and sleep throughout the night and to awake without meaningful residual effects is important for overall health and well-being, and we are pleased to be part of the development of a new potential treatment that makes a difference for people with insomnia,” says Marcelo Bigal, MD, PhD, chief medical officer at Purdue Pharma, in a release. “In collaboration with our partners at Eisai, we’re looking forward to announcing additional near-term milestones for lemborexant.”

Non-clinical research data from the course of discovery of lemborexant, including medicinal chemistry and pharmacological evaluation, will also be presented at the meeting.

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.