Sensorion’s bid to rebuild confidence in its hearing loss drug candidate SENS-401 has gathered another data point. After seeing the small molecule fail in one indication last year, the French biotech has now provided very early evidence that it may protect against hearing loss in another setting.
In the earlier trial, the drug candidate failed to provide the hoped for 15-decibel improvement compared to placebo in patients with sudden sensorineural hearing loss (SSNHL), causing the phase 2 study to miss its primary endpoint. Sensorion continues to see a future for the asset in SSNHL and wants to partner for late-stage development, but its teams are now focused on generating data in other hearing conditions.
Hearing preservation after cochlear implantation is one of two other indications targeted by the biotech. Last month, Sensorion reported (PDF) that SENS-401 was found at a level “compatible with therapeutic efficacy” in a fluid in the inner ears of five patients who took the drug before cochlear implantation.
Now, the biotech has shared secondary endpoint data from the phase 2a trial. The update reveals that the loss of residual hearing in the five recipients of SENS-401 was 12 decibels, compared to a loss of 33 decibels in the control cohort.
“This level of residual hearing preservation means patients have a better chance of understanding speech against background noise and perceiving more natural sound quality with speech and sounds,” Sensorion CEO Nawal Ouzren said in a statement.
The clinical trial is small, and its findings need validating in larger studies before Sensorion can conclude that SENS-401 improves outcomes in patients undergoing cochlear implantation. Sensorion is working to show the candidate is effective in the cochlear indication while also testing its ability to prevent damage to the ear in patients receiving the chemotherapy drug cisplatin.
Shares in Sensorion rose 9% to 34 euro cents ($0.36) by 2 p.m. trading in Paris in the wake of the cochlear data. The stock traded around 2 euros before Sensorion released news of the failure of SENS-401 in SSNHL early last year.