MONTPELLIER, FRANCE — French biotech firm, Sensorion, announced the upcoming publication this week in the Journal of Otology & Neurotology of a new study showing oral clinical-stage SENS-401 (the company’s investigative drug) significantly prevented cisplatin-induced hearing loss in preclinical models.
Cisplatin, a commonly-used chemotherapy agent to treat various forms of cancer, causes significant levels of hearing loss in 50-60% of treated patients. At this time there are no pharmaceutical treatments available to address this issue.
Preventing Hearing Loss from Chemotherapy Treatment
In the studies, rats randomly received either a daily oral administration of SENS-401 or placebo. Auditory brainstem response (ABR) and distortion product otoacoustic emission (DPOAE) tests were performed at baseline, and after 14 days of SENS-401 administration at varying doses (6.6, 13.2, 26.4 mg/kg/d)
According to the study results:
- All dose levels showed significant activity versus placebo in the preventing of cisplatin-induced hearing loss (greater than 50%)
- All dose levels of oral SENS-401 significantly reduced the loss of outer hair cells, by up to 10 fold
- SENS-401 did not reduce the cytotoxic effect of cisplatin on human cancer cell lines in vitro at concentrations close to 30 fold the expected therapeutic concentrations.
In vivo, all SENS-401 doses significantly improved ABR threshold shift (up to 30 dB) and DPOAE amplitude loss (up to 19 dB), compared with placebo. Significantly more surviving outer hair cells were found to be present after SENS-401 treatment when compared with placebo, with up to eleven times more surviving outer hair cells found in the basal turn of the cochlea.
Hearing Drug Data Submitted to FDA
According to Sensorion, the in vivo and in vitro data support the otoprotective potential and tolerance of SENS-401 without negatively impacting the chemotherapeutic potential of cisplatin.
“These preclinical results further demonstrate the activity of SENS-401 in the prevention and treatment of cisplatin-induced hearing loss. These data also support the activity of this drug candidate shown in models of noise-induced hearing loss. Collectively, the results from these studies confirm the therapeutic potential of SENS-401.” –Pierre Attali, Chief Medical Officer of Sensorion
The data from the studies has been submitted to the FDA, which the company said supports the Orphan Drug Designation recently granted to SENS-401 for prevention of platinum-induced ototoxicity in pediatric patients.
The company intends to conduct Phase 2 clinical trials for SENS-401 in 2018.
Oral Administration of Clinical Stage Drug Candidate SENS-401 Effectively Reduces Cisplatin-Induced Hearing Loss in Rats. M Petremann et al. Otol Neurotol. 2017 Aug 08