SUVN-G3031 (Samilisant)

A potent, selective, brain penetrant and orally active Histamine H3 inverse agonist for the treatment of cognitive dysfunction associated with AD / Schizophrenia. SUVN-G3031 completed all the Pre-clinical, Safety, early Tox and GLP Tox studies. US IND has been approved in Sept-2014. Phase-1 SAD & MAD studies have been completed. SUVN-G3031 demonstrated   excellent safety profile and PK.

 

A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN‑G3031 Compared to Placebo in Patients with Narcolepsy with and without Cataplexy commenced in Aug 2019 with a targeted enrollment of 114 subjects in USA.

 

The ongoing phase 2 study in USA has been presented to the Data Safety Monitoring Board (DSMB) for interim analysis and the DSMB did not find any safety related issues. During the meeting DSMB suggested for better outcome of the trial, a key secondary endpoint ESS (Epworth Sleepiness Scale) in addition to the Primary end point of MWT (Maintenance of Wakefulness Test) which is being tested at present. This led to addition of 57 patients and with this the total number of patients increased from 114 to 171 and the study is expected to complete by end of the year 2022. 

  

Covid conditions in US affected this study in enrollment of patients and with the increase of 57 patients for the study it is going to be taking another 18 months to close this study.