Biotechnology company Sensorion has enrolled the first patient in its Phase IIa Proof of Concept clinical trial of SENS-401 (Arazasetron) in patients suffering from cisplatin-induced ototoxicity.
Cisplatin and other platinum-based compounds are essential chemotherapeutic agents for many cancers. A serious side effect of these therapies is ototoxicity, or permanent and irreversible hearing loss, which occurs in up to 50-60% of adult patients and 90% of paediatric patients who survive cancer.
The exploratory Phase IIa study, NOTOXIS, aims at evaluating the efficacy of SENS-401 to prevent ototoxicity induced by cisplatin in adult patients with a neoplastic disease.
“The need to find a solution for cisplatin-induced ototoxicity is paramount,” said Géraldine Honnet, Chief Medical Officer of Sensorion. “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.”
In a preclinical model of cisplatin-induced ototoxicity (Petremann et al, 2017), SENS-401 demonstrated an ability to significantly reduce hearing loss.
Clinical trial details
The NOTOXIS amended clinical trial application (CTA) was approved in October 2022 in France and in December 2022 in Israel.
Eligible participants will be randomised on Day 1 to either Arm A or Arm B in ratio 1:1 (the aim is to enroll maximum 58 participants in total: 29 participants per arm).
Arm A participants will be treated with cisplatin-based chemotherapy without receiving SENS-401. This control arm will provide natural history data.
Arm B participants will receive 43.5mg of oral SENS-401 one week prior to the initiation of the cisplatin treatment, during the whole duration of the chemotherapy treatment and four weeks after receiving the last cycle of cisplatin.
The primary objective of the study will be to assess SENS-401 efficacy, measuring the change from baseline of the average of the Pure Tone Audiometry (PTA) four weeks after the completion of cisplatin treatment.
The trial will also assess a number of secondary outcome measures, including the rate and severity of ototoxicity, the change in PTA (dB) throughout the study and tolerance.
Sensorion anticipates the publication of interim data in H1 2023.
