Date: 2017-06-08
Type of
information: Results
phase: 1
Announcement: results
Company: Sensorion (France)
Product: SENS-401
Action
mechanism:
- setron/selective-5-ht3-receptor-antagonist. R-azasetron besylate aims to protect and preserve inner ear tissue when lesions are present that can cause progressive or sequelar hearing impediments. It is one of the two enantiomer forms of SENS-218, azasetron, a racemic molecule belonging to the family of setrons marketed in Asia under the name Serotone.
Disease: inner ear lesions
Therapeutic
area: Otorhinolaryngology
Country: UK
Trial
details:
Latest
news:
- • On June 8, 2017, Sensorion announced the positive results of the phase 1 clinical trial of SENS-401 treatment of inner ear lesions. The study has validated the compound's safety and
pharmacokinetic profile. The phase 1 trial was carried out in the United Kingdom on 36 healthy volunteers with the aim of assessing SENS-401’s tolerability at various doses compared to a placebo and defining its pharmacokinetic profile.
SENS-401 was administered orally at 29 mg and 43.5 mg doses once or twice a day over a 7-day period. The trial confirmed the very good clinical tolerance of SENS-401 and the pharmacokinetic data enable Sensorion to select the doses to be used in phase 2 testing.
The plasma concentrations obtained correspond to those observed in animal models that showed the effect of SENS-401 on severe noise-induced hearing loss1 or Cisplatin-induced hearing loss. Sensorion will now define the optimal strategy for the phase 2 clinical development of SENS-401 to treat severe hearing loss.
Is
general: Yes
