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Positive efficacy data for Sensorian’s candidate I QUANTUNG Pharma

SENS-401 has been developed for hearing preservation among adult patients following cochlear implantation

Sensorion – a company which focuses on the development of novel therapies to treat hearing loss disorders – has reported further analysis from its proof-of-concept phase 2a clinical trial of SENS-401. The candidate has been developed for residual hearing preservation in adult patients following cochlear implantation.

The phase 2a trial is a randomised, controlled open-label trial aimed at evaluating the presence of the SENS-401 candidate in the perilymph after seven days of twice-daily oral administration in adult patients.

Sensorion had recently announced that in preliminary data from the phase 2a research, SENS-401 was detected in the perilymph of all five individuals treated with the therapy. Indeed, levels of the candidate were consistent with potential therapeutic effects after a week of repeated oral treatment.

Pivotally, the new data also demonstrates that the study met a number of secondary endpoints, including the change of hearing threshold from baseline to the end of the treatment period in the implanted ear at several frequencies.

Meanwhile, in the SENS-401-treated group, the loss of residual hearing was only 12 dB, in contrast with a more significant loss of 33 dB observed in the control group of four participants who were not provided with the treatment.

This resulted in a difference of clinical significance, suggesting that SENS-401 had delivered a protective effect on early residual hearing loss after cochlear implantation.

Géraldine Honnet, chief medical officer at Sensorion, reflected: “Two weeks ago we demonstrated that SENS-401 crossed the labyrinthine barrier to the cochlea. Today, following further analysis, we have gone much further and have shown SENS-401 potential to preserve early residual hearing six weeks after cochlear implantation.”

She added: “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 ground-breaking therapy with great potential in an area of significant unmet need and we are looking forward to seeing the final results of the study.”

Nawal Ouzren, chief executive officer at Sensorion, concluded: “We are very excited to see such promising new preliminary data for our ongoing phase 2a clinical study of SENS-401. This is great news for our programme and supports our confidence in the potential of our innovative therapy to prevent residual hearing loss in adult patients suffering from moderately severe to profound hearing disorders.

“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.”


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