0759 Phase 2 Proof Of Concept Study Of SUVN-G3031, A Histamine H3 Receptor Inverse Agonist For The Potential Treatment Of Narcolepsy

Abstract

Abstract Introduction SUVN-G3031 is a potent inverse agonist at histamine H3 receptor (H3R) with selectivity over 70 other targets. SUVN-G3031 has excellent pharmacokinetics in rats and dogs. SUVN-G3031 demonstrated dose dependent receptor occupancy in rats with marked wake-promoting and anticataplectic effects in orexin knockout mice supporting its potential therapeutic utility in the treatment of narcolepsy. Long-term safety studies in animals and Phase 1 evaluation for safety, tolerability and pharmacokinetics demonstrated no concern for further development of SUVN-G3031. Methods SUVN-G3031 is currently being evaluated in a Phase 2 proof of concept study in USA for the treatment of narcolepsy with and without cataplexy (ClinicalTrials.gov Identifier: NCT04072380). This is a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SUVN-G3031 in comparison to placebo in patients with narcolepsy with and without cataplexy. Participants with an ESS score of ≥ 12; and mean MWT time of < 12 min are being randomized at a ratio of 1:1:1 to 2 mg SUVN-G3031, 4 mg SUVN-G3031 or placebo. Patients are to be stratified based on the type of narcolepsy. Each patient will receive study drug once daily for 14 days. The primary objective of the study is to evaluate the effectiveness of SUVN-G3031 compared to placebo as measured by an improvement in the maintenance of wakefulness test (MWT) score. Various secondary, exploratory, safety endpoints and steady state plasma concentrations will be evaluated. Results This study has been initiated in Q3 2019 and subject recruitment is expected to be completed by Q2 2020. Conclusion This study is a phase 2 clinical trial evaluating the efficacy and safety of SUVN-G3031 as a monotherapy in patients with narcolepsy with and without cataplexy. Safety and efficacy results from the study are expected in Q3 2020. Support None