The exploratory, randomised, multicentre, controlled, open-label NOTOXIS clinical trial will assess SENS-401’s efficacy for the prevention of ototoxicity induced by the cisplatin compound in adult neoplastic disease patients.
Eligible trial participants will be randomised on day one into either Arm A or Arm B on a 1:1 basis.
A maximum of 58 participants in total are expected to be enrolled, with 29 participants in each arm.
Participants in Arm A will receive treatment with cisplatin-based chemotherapy without receiving SENS-401.
Arm B subjects will be given 43.5mg of oral SENS-401 one week before starting the cisplatin treatment, during the complete duration of the chemotherapy treatment, and four weeks after receiving the last cisplatin cycle.
The trial’s primary objective will be the evaluation of SENS-401 efficacy measuring the change from baseline of the average Pure Tone Audiometry (PTA) four weeks after concluding cisplatin treatment.
In addition, the trial will evaluate several secondary outcome measures including the change in PTA (dB) throughout the study, tolerance, and the rate and severity of ototoxicity.
Sensorion chief medical officer Géraldine Honnet said: “While Cisplatin is a highly effective treatment for many cancers, it is associated with hearing loss in so many adult and paediatric patients.
“The preclinical and clinical data gathered during SENS-401 development support Sensorion’s confidence in its potential to preserve hearing for patients receiving cisplatin, without impacting chemotherapeutic potential, and we are therefore very excited to be commencing this trial.”
Interim data from the trial is expected in the first half of this year.
Ototoxicity, or permanent and irreversible hearing loss, occurs in up to 50-60% of adult and 90% of paediatric patients who survive cancer.
In January last year, Sensorion’s Phase II AUDIBLE-S clinical trial of SENS-401 to treat sudden sensorineural hearing loss failed to meet the primary goal.