Suven Life Sciences Ltd shares settled at ₹75.56 per piece, locked in the upper circuit of 20% on the BSE in Monday’s trading, as the Street turned bullish on the pharma scrip. Suven Life announced positive topline results for a study that addresses excessive daytime sleepiness (EDS) in adults with narcolepsy patients.

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The biopharmaceutical company said that the Phase-2 study for the safety and efficacy of Samelisant in order to treat EDS in adult narcolepsy patients with and without cataplexy has garnered positive topline results, it said in an exchange filing.

Suven Life Sciences stated that ‘Samelisant’ achieves a primary efficacy endpoint and meaningfully reduces the total score of the Epworth Sleepiness Scale (ESS) compared to placebo at Day 14 when utilised as a monotherapy.

“Highly statistically significant effects were observed against placebo for the other efficacy endpoints like the Clinical Global Impression of Severity (CGI-S) score related to EDS, Patient Global Impression-Change (PGI-C), and Clinical Global Impression of Change (CGI-C),” noted the life sciences company in the release.

Samelisant was generally found safe and well tolerated, while no serious adverse events or death was reported in the study conducted by Suven Life Sciences.

The company now plans to approach the United States Food and Drug Administration (USFDA) in the first quarter of 2024 for an End-of-Phase-2 (EOP2) meeting in order to discuss the study results and seek the regulator’s guidance for the pivotal Phase-3 study.

Suven will also present the topline data from the aforementioned clinical trial at the Neuroscience-2023 (Society for Neuroscience’s annual meeting) scheduled to be held in Washington, DC, from November 12 to 15.

However, the results of the full study will be submitted by the company for scientific publication at a later date.

(Edited by : Ajay Vaishnav)