France-based Sensorion has announced that its hearing loss candidate SENS-401 has a protective effect on early residual hearing loss after cochlear implantation.

A Phase IIa proof of concept trial (NCT05258773) evaluating SENS-401’s (arazasetron) residual hearing preservation effect in adult patients following cochlear implantation has met a number of secondary endpoints.

These met endpoints included the change of hearing threshold from baseline to the end of the treatment period in the implanted ear at several frequencies. Sensorion has not yet confirmed whether the drug has met the primary endpoint.

On 19 June 2023, Sensorion announced that in preliminary data, SENS-401 was detected in the perilymph of all five adult patients treated at levels considered consistent with potential therapeutic effects.

GlobalData said that based on these results, SENS-401 shows therapeutic efficacy by crossing the labyrinth barrier, which positively affects residual hearing preservation.

GlobalData is the parent company of the Clinical Trials Arena.

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Difference of 21 dB

The residual hearing loss in the treated group was 12dB, compared with a loss of 33dB in the control group of four participants, with a difference of 21dB between the two groups. Sensorion said the data suggests that SENS-401 provided a protective effect on early residual hearing loss after cochlear implantation.

The trial was a multicentric, randomised, controlled open-label trial aimed at evaluating the presence of the candidate in the cochlear (perilymph) after seven days of twice-daily oral administration in adult patients with moderately severe to profound hearing impairment prior to cochlear implantation. Patients started treatment with SENS-401 seven days before implantation and continued to receive the candidate for a further 42 days.

Sensorion chief medical officer Dr Géraldine Honnet said: “Patients treated with SENS-401 showed improved hearing preservation compared to the patients in the control group, corroborating the otoprotective potential of the molecule.

“We believe SENS-401 is a groundbreaking therapy with great potential in an area of significant unmet need and we are looking forward to seeing the final results of the study.”

How SENS-401 works

SENS-401 elicits vestibuloprotective activity by antagonising histamine 4 receptors (H4R) and 5 hydroxytryptamine receptors (5-HT3). H4R is a G-protein-coupled histamine receptor that is expressed in various cell types. SENS-401 binds to H4R and suppresses the primary vestibular neuron firing.

SENS-401 has received orphan drug designation and paediatric investigation plan from the European Medicines Agency (EMA).

In January 2022, Sensorion announced that the Phase II AUDIBLE-S clinical trial of SENS-401 to treat sudden sensorineural hearing loss failed to meet the primary goal. The company is also conducting a phase II clinical trial assessing the efficacy of SENS-401 for the prevention of cisplatin-induced ototoxicity.