(News Bulletin 247) – The Montpellier biotech has reported preliminary data from an intermediate clinical trial showing that its drug candidate SENS-401, a small molecule that must preserve the tissues of the inner ear, had a clinically significant effect on preservation of residual hearing.

It was a must-attend event for Sensorion: the publication of preliminary data from a clinical study for its most advanced drug candidate, SENS-401.

This molecule developed by the Montpellier biotech specializing in the treatment of hearing disorders can be administered orally. It aims to preserve the tissues of the inner ear against damage that may lead to progressive or sequelae hearing loss (ie related to the sequelae of a disease).

Sensorion had published first results in mid-June showing that this molecule crossed the labyrinthine barrier of the ear to reach the cochlea, a bony canal located in the inner ear. This channel contains cells that pick up sound frequencies from which they produce a nervous message that is then transmitted to the brain. Involvement of the cochlea was the primary endpoint of the study.

This time, the additional data from this phase 2a trial (intermediate stage before phase 3, which is the last before potential marketing) show that the secondary endpoint, namely the preservation of hearing significantly compared to the control group – i.e. study participants who did not receive SENS-401 – was reached.

This trial administered SENS-401 orally twice daily to patients seven days before cochlear implantation (a cochlear implant is a miniaturized device that stimulates the cochlea with electrodes to improve hearing). Patients in the study then received the treatment for 42 days after implantation. The idea is that the Sensorion molecule should make it possible to reduce residual hearing loss due to the placement of the implant electrode. This will then facilitate post-implant rehabilitation and therefore the improvement of the patient’s hearing.

>> Access our exclusive graphic analyses, and enter into the confidence of the Trading Portfolio

Towards a potential licensing agreement with Cochlear

In the end, patients treated with SENS-401 “demonstrated the preservation of 21 decibels of their residual hearing compared to the control group, six weeks after cochlear implantation at 500 hertz,” the company said in a press release.

“In the group treated with SENS-401 (N=5 or a population of five patients), the change was only 12 decibels, contrasting with a more significant change of 33 decibels observed in the control group with four participants not treated with SENS-401. This resulted in a clinically significant difference of 21 decibels between the two groups, demonstrating that SENS-401 had a protective effect on early residual hearing loss after cochlear implantation.”

“This level of residual hearing preservation increases patients’ chances of better distinguishing speech from background noise and enjoying more natural sound quality with both speech and sound,” she said. Nawal Ouzren, general manager of Sensorion, quoted in a press release.

On the Paris Stock Exchange, the Sensorion share rose sharply, gaining 7.7% at the start of the afternoon following these announcements.

The clinical study is co-financed by implant specialist Cochlear, an ally of Sensorion. The Australian company also has a right of first negotiation for a worldwide licensing agreement for the treatment of patients with certain hearing implants with SENS-401. This option will be triggered when the final results of the phase 2 study are published, expected in the first half of 2024.

To continue its development, the “biotech” will work to find sources of funding by the end of the year. When publishing its annual results, the group explained that it had cash of 26.2 million euros at the end of December 2022, which allows it to ensure business continuity until the end of 2023. It should to be able to rely on the support of two reference investors: Invus Public Equities, and Sofinnova partners, two funds which own more than 40% of the current capital.