seliforant (SENS-111) / Sensorion, Uriach Pharma - LARVOL DELTA

Management of peripheral vertigo with antihistamines: new options on the horizon. (PubMed, Br J Clin Pharmacol) - "To address these issues, the timing of administration of betahistine, the mainstay H antihistamine, can be fine-tuned, while bioavailability is also being improved. The preclinical potential of SENS-111 (Seliforant), an oral first-in-class selective H antagonist is the only such molecule to date to be translated into the clinical setting. With an excellent safety profile and notable absence of sedation, encouraging outcomes in an induced vertigo model in healthy volunteers have led to ongoing clinical studies in acute unilateral vestibulopathy, with the hope that H antagonists will offer new effective therapeutic options to patients suffering from vertigo."

Journal • Review • Anesthesia • Otorhinolaryngology • Vertigo

SENS 111-201: Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy (clinicaltrials.gov) - P2; N=107; Completed; Sponsor: Sensorion; Recruiting ➔ Completed

Clinical • Trial completion

Safety, tolerability, pharmacokinetics and pharmacokinetic-pharmacodynamic modelling of the novel H receptor inhibitor SENS-111 using a modified caloric test in healthy subjects. (PubMed, Br J Clin Pharmacol) - "SENS-111 is a well-tolerated first-in-class H receptor antagonist with acceptable PK for oral daily dosing. PK/PD modelling determined plasma concentrations and doses for efficacy studies in patients with vertigo symptoms."

Clinical • Journal • PK/PD data

Effect of the novel histamine H receptor antagonist SENS-111 on spontaneous nystagmus in a rat model of acute unilateral vestibular loss. (PubMed, Br J Pharmacol) - "The exposure/efficacy relationship for improved spontaneous nystagmus seen with SENS-111 in this in vivo model is consistent with phase 1 clinical results and provides preclinical support for pharmacokinetic/pharmacodynamic modelling and selection of effective clinical drug concentrations."

Journal • Preclinical

SENS 111-201: Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy (clinicaltrials.gov) - P2; N=105; Recruiting; Sponsor: Sensorion; Phase classification: P2/3 ➔ P2; N=207 ➔ 105; Trial completion date: Dec 2018 ➔ Dec 2019; Trial primary completion date: Dec 2018 ➔ Dec 2019

Clinical • Enrollment change • Phase classification • Trial completion date • Trial primary completion date