Sensorion has introduced that the primary affected person has been enrolled in its section 2a proof of idea scientific trial of SENS-401 (Arazasetron) in sufferers affected by cisplatin-induced ototoxicity.
Cisplatin and different platinum-based compounds are important chemotherapeutic brokers for a lot of cancers. A severe aspect impact of those therapies is ototoxicity, or everlasting and irreversible listening to loss, which happens in as much as 50-60% of grownup sufferers and 90% of pediatric sufferers who survive most cancers.
This indication represents a major unmet want for sufferers and is a big potential market with an estimated incidence of greater than 500,000 sufferers within the U.S., the European Union and Japan.
Want is ‘paramount’
The exploratory section 2a, multicenter, randomized, managed, open-label research, NOTOXIS, goals at evaluating the efficacy of SENS-401 to stop ototoxicity induced by cisplatin in grownup sufferers with a neoplastic illness.
“The necessity to discover a answer for cisplatin-induced ototoxicity is paramount,” stated Géraldine Honnet, chief medical officer of Sensorion.
“Whereas Cisplatin is a extremely efficient remedy for a lot of cancers, it’s related to listening to loss in so many grownup and pediatric sufferers. The preclinical and scientific knowledge gathered throughout SENS-401 growth help Sensorion’s confidence in its potential to protect listening to for sufferers receiving cisplatin with out impacting chemotherapeutic potential and we’re subsequently very excited to be commencing this trial.”
Approvals in France and Israel
In a preclinical mannequin of cisplatin-induced ototoxicity (Petremann et al., 2017), SENS-401 demonstrated a capability to considerably scale back listening to loss. Additional evaluation of the AUDIBLE-S research earlier in 2022, to evaluate the impact of SENS-401 in sudden sensorineural listening to loss (SSNHL), demonstrated a statistically vital and clinically significant remedy impact. These knowledge have knowledgeable the NOTOXIS trial design to increase exposition to SENS-401 remedy, with a purpose to cowl all of the cycles of cisplatin and to concentrate on the prevention of listening to loss.
The NOTOXIS amended scientific trial software (CTA) was accepted in October 2022 in France and in December 2022 in Israel.
The first goal of the research shall be to evaluate SENS-401 efficacy measuring the change from baseline of the common of the pure tone audiometry (PTA) 4 weeks after the completion of cisplatin remedy.
The trial can even assess secondary end result measures, together with the speed and severity of ototoxicity, and the change in PTA (dB) all through the research and tolerance.
Sensorion anticipates the publication of interim knowledge in H1 2023.
About Sensorion’s SENS-401
SENS-401 (Arazasetron), Sensorion’s scientific stage lead drug candidate, is an orally obtainable small molecule that goals to guard and protect inside ear tissue from injury accountable of progressive or sequelae listening to impairment. Sensorion is at present growing SENS-401 in a section 2a scientific trial for the prevention of residual listening to loss in sufferers scheduled for cochlear implantation, and in a section 2 scientific trial for the prevention of cisplatin-induced ototoxicity.
Sensorion’s SENS-401 has been granted orphan drug designation by the EMA in Europe for the remedy of sudden sensorineural listening to loss, and by the FDA within the U.S. for the prevention of platinum-induced ototoxicity within the pediatric inhabitants.