India-based Suven Life Sciences, a clinical-stage biopharmaceutical company developing novel medicines to treat central nervous system disorders, announced positive topline results from its phase 2 proof-of-concept study assessing the safety and efficacy of samelisant for the treatment of excessive daytime sleepiness in adult narcolepsy patients with and without cataplexy.
The study met the primary endpoint, with samelisant demonstrating a statistically significant and clinically meaningful reduction in excessive daytime sleepiness measured by the Epworth Sleepiness Scale total score compared to placebo at day 14.
Highly statistically significant effects were observed against placebo for the other efficacy endpoints like Clinical Global Impression of Severity score related to excessive daytime sleepiness, Patient Global Impression-Change, and Clinical Global Impression of Change.
Exposures of samelisant in narcolepsy patients were observed to be in agreement with the exposures from phase 1 studies in healthy subjects. These plasma concentrations of samelisant were projected to be sufficient to achieve the receptor occupancy required to demonstrate efficacy in narcolepsy patients. Samelisant was generally safe and well tolerated. There were no serious adverse events or deaths reported in the study.
“We are thrilled by these compelling topline results and the magnitude of improvement observed for narcolepsy patients in this study with samelisant as a monotherapy. We are deeply grateful to the patients and investigators who participated in the study,” says Venkat Jasti, chairman and CEO of Suven Life Sciences, in a release.
Suven plans to approach the US Food and Drug Administration (FDA) in the first quarter of 2024 for an end-of-phase-2 meeting to discuss the study results and seek the agency’s guidance for a pivotal phase 3 study.
Ramakrishna Nirogi, vice president of drug discovery and development at Suven Life Sciences adds in a release, “These results demonstrate rapid onset of action of samelisant and its ability to significantly address the symptoms of [excessive daytime sleepiness] that impair quality of life in narcolepsy patients. We look forward to working closely with the FDA as we focus on our goal to advance Samelisant to the phase 3 clinical development program.”
Topline data from the clinical trial are scheduled to be presented at Neuroscience 2023 to be held in Washington, DC, from Nov 12-15. The full study results are planned to be submitted for scientific publication at a later date.