France-based Sensorion has announced preliminary safety data from the Phase IIa trial investigating SENS-401 in patients suffering from cisplatin-induced ototoxicity.
The Phase IIa named NOTOXIS trial showed that SENS-401 (arazasetron) had a favourable safety profile when administered continuously for up to 11 weeks in adult patients undergoing cisplatin-based chemotherapy.
Cisplatin-induced ototoxicity is hearing impairment caused by cisplatin treatment, which can manifest as ringing in the ear (tinnitus), high-frequency hearing loss, and at late stages, a decreased ability to hear normal conversation.
The multicentre, randomised, controlled, open-label study (NCT05628233) aims to assess several outcome measures, including the rate and severity of ototoxicity, the change from baseline in Pure Tone Audiometry (PTA) (dB) and tolerance.
Participants were randomised in a ratio of 1:1 into two cohorts. Patients in the treatment arm are receiving 43.5 mg of oral SENS-401 for up to 23 weeks, starting one week before the initiation of the cisplatin treatment and ending four weeks after stopping chemotherapy.
In the control arm, patients are receiving cisplatin-based chemotherapy without receiving SENS-401. All subjects will be followed up to 12 weeks after the completion of the cisplatin therapy.
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Patients in the study will receive high doses of cisplatin, exceeding 70mg/m² per treatment cycle and totalling at least 210mg/m² throughout their chemotherapy regimen. The primary completion date for the study is set for June 2024, according to the ClinicalTrials.gov registry.
Professor Yann Nguyen, an ear, nose and throat (ENT) surgeon at Hospital Pitié Salpêtrière in Paris, said: “It has become paramount to acknowledge the severe and irreversible hearing losses that frequently follow cisplatin treatments and to encourage the development of therapeutic solutions to mitigate this severe effect without interfering with cisplatin efficacy.”
SENS-401 is also progressing in a Phase IIa trial for the prevention of residual hearing loss following Cochlear implantation alongside partner Cochlear. In July 2023, Sensorion announced the trial met its secondary endpoints.
Last year, the asset failed to meet the primary endpoint in a Phase II trial investigating the candidate as a treatment for sudden sensorineural hearing loss (SSNHL).
According to GlobalData’s Pharmaceutical Intelligence Centre, Sensorion has two ongoing trials, seven completed trials, one withdrawn trial and three planned trials of SENS-401.
GlobalData is the parent company of the Clinical Trials Arena.