Date: 2015-11-19
Type of information: Results
phase: 1b
Announcement: results
Company: Sensorion (France)
Product: SENS-111
Action
mechanism: histamine-H4 receptor antagonist. SENS-111 is the first representative of the histamine type 4 receptor antagonist class tested in inner-ear pathologies. This drug candidate displays a neuromodulation effect of the neurosensorial inner ear cell function and is being developed for the symptomatic treatment of bouts of vertigo or tinnitus. SENS-111 is a small molecule that can be taken orally or via a standard injection, and is currently tested in human in phase 1b.
Disease: inner-ear pathologies
Therapeutic area: Otorhinolaryngology
Country:
Trial details:
Latest
news: * On November 19, 2015, Sensorion, a biotech specialising in the treatment of inner ear diseases, announced the success of phase 1b of the clinical trial on the SENS-111 drug candidate . Increasing doses of the SENS-111 compound were assessed among 100 healthy volunteers in a phase 1b clinical trial aimed at supplementing the initial clinical tolerance data available (with 50mg and 100mg doses). This study aimed to establish, from pharmacokinetic and pharmacodynamic data, the range of potentially efficient * On April 23, 2015, Sensorion announced the successful completion of the first part of the clinical trial on its SENS-111 drug candidate and the continuation of the second part. SENS-111, which aims to treat severe bouts of vertigo, is one of a comprehensive portfolio of drug candidates chosen by Sensorion to cover all severe inner ear pathologies. A phase 1b clinical trial is currently taking place to supplement the existing pharmacokinetic and clinical tolerance data on the SENS-111 product and to provide information regarding use of the caloric test, a pharmacodynamics test used in clinical practice by ENT specialists on patients suffering from dizziness. This study, for which the recruitment of healthy volunteers began in January 2015, comprises two parts:
doses for treating bouts of severe vertigo. Following the very positive results obtained in part 1 of the study (see the press release of April 23, 2015), part 2 of the study, which consisted in administering repeated oral doses of SENS-111 or a placebo over a period
of 4 to 7 days with increasing doses (up to 500mg), has confirmed very high tolerance and the compound’s pharmacokinetic profile. No significant adverse effects were observed in the group of subjects treated with SENS-111, even at very high doses, illustrating this drug candidate’s excellent safety profile.
Pharmacokinetic data showed a good correlation between the administered dose and plasma concentrations. Combined with the caloric test whose aim was to reproduce the symptoms of patients with severe vertigo in healthy subjects, they enabled the range of doses that should be tested in vestibular pathologies to be determined. These results will allow the Company to begin, as planned, the phase 2 clinical trial among patients with severe vertigo associated with vestibulopathy during the 2nd quarter of 2016.
- Part 1: a study of single oral doses of SENS-111 or a placebo, with increasing doses;
- Part 2: a study of repeated oral doses of SENS-111 or a placebo over 4 to 7 days, with increasing doses and the carrying out of the caloric test.
In part 1 of this study, involving 4 cohorts of 8 subjects, the doses foreseen by the protocol were achieved with no significant adverse effects observed. The plasma concentrations obtained with SENS-111 were significantly higher than those identified as efficient by Sensorion via its screening platform. The study’s steering committee has therefore decided to end the recruitment of further subjects for this part of the study. Regarding part 2 of the study, no significant adverse effects have been observed on the first 2 cohorts of 12 subjects involved in the study in accordance with the study’s schedule. Recruitment for this part of the study is continuing, and the pharmacokinetic and pharmacodynamic data – notably the results of the caloric tests – will be available during the final quarter of 2015.
These results mean that the development of SENS-111 for the symptomatic treatment of severe vertigo can continue on schedule. The phase 2 clinical trial on SENS-111 should thus be able to begin in 2016 in patients from the general population or presenting an orphan disease of the inner ear.
