Sensorion a pioneering clinical-stage biotechnology company dedicated to the development of innovative therapies to restore, treat and prevent hearing loss, today publishes a complementary analysis of its phase 2a clinical trial of proof of concept (POC) conducted with SENS-401 in the preservation of residual hearing in adult patients following cochlear implantation. The analysis of this preliminary data will be presented during the KOL webinar organized by the Company this Wednesday, July 5, 2023 (details of the event below).

On June 19, 2023, Sensorion announced that in preliminary data from the Phase 2a study, SENS-401 was detected in the perilymph of all 5 adult patients treated with the product. SENS-401 levels were considered consistent with potential therapeutic effects after seven days of repeated oral treatment.

A number of secondary endpoints were also assessed in the study, including the change in hearing threshold between the start and end of the treatment period in the implanted ear, at multiple frequencies. Study entry criteria required that patients have a pure tone audiometry (PTA) threshold of 80 dB or better (i.e., <80 dB) at 500 Hz, defined as indicating a level minimal residual hearing. Further analysis indicates that patients treated with SENS-401 demonstrated preservation of 21 dB of their residual hearing compared to the control group, six weeks after cochlear implantation at 500 Hz.

In the SENS-401 treated group (N=5), the residual hearing loss was only 12 dB, contrasting with a greater loss of 33 dB observed in the control group with four participants not treated with SENS -401. This results in a clinically significant difference of 21 dB between the two groups, demonstrating that SENS-401 had a protective effect on early residual hearing loss after cochlear implantation. These original and promising results reinforce the hypothesis that SENS-401, by crossing the labyrinthine barrier to reach the cochlea, has a positive effect on the preservation of residual hearing.

The Phase 2a trial is a multicenter, randomized, controlled, open-label trial to evaluate the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult patients prior to cochlear implantation to treat moderately severe to profound hearing loss. Patients start treatment with SENS-401 7 days before implantation and continue to receive SENS-401 for 42 days.

Nawal Ouzren, Chief Executive Officer of Sensorion, said : “We are very pleased to present such promising new preliminary data for our ongoing Phase 2a clinical study of SENS-401. This is great news for our program and reinforces our confidence in the potential of our innovative therapy to prevent residual hearing loss in adult patients with moderately severe to profound hearing impairment. This level of preservation of residual hearing increases the chances of patients better distinguishing speech in noise and enjoying a more natural sound quality with both speech and sound.

Geraldine Honnet, MD, Medical Director of Sensorion, added “Two weeks ago, we demonstrated that SENS-401 crosses the labyrinthine barrier to the cochlea. Today, after new positive analyses, we go much further and are able to prove that SENS-401 has the potential to preserve early residual hearing six weeks after cochlear implantation. Better preservation of hearing was observed in patients treated with SENS-401, compared to patients in the control group, which confirms the otoprotective potential of the molecule. We believe SENS-401 is an innovative therapy with great potential in an area of unmet need and we look forward to the final results of the study.

Online seminar

Sensorion's webinar, taking place today Wednesday, July 5, 2023, will include a presentation by KOL Professor Yann Nguyen MD, Ph.D., who will outline the reasons for the importance of preserving residual hearing and will provide an overview of the surgical procedure developed for perilymph harvesting.

Members of Sensorion's leadership team will share further analysis of preliminary data from the Phase 2a POC study of SENS-401 for preservation of residual hearing in patients undergoing cochlear implants due to severe to profound hearing loss. The study was developed in collaboration with Cochlear Ltd., world leader in implantable hearing solutions and partner of Sensorion.

A question and answer session will follow the presentation, which will be live captioned.

Professor Yann Nguyen is a professor in the ear, nose and throat department of the Pitié Salpêtrière University Hospital (Sorbonne University, AP-HP), in Paris, France. His clinical activities are devoted to middle ear surgery, cochlear implantation and lateral skull base surgery. He holds a doctorate in “robotic surgery for cochlear implantation”. He currently works at the Hearing Institute (Institut Pasteur/Inserm), where he devotes his work to robotics and directs the “RobOtol” project. Professor Nguyen aims to design and evaluate surgical solutions for the treatment of hearing loss, from the laboratory to the operating room.

Sensorion KOL Webinar Wednesday, July 5, 2023
11:00 a.m. - 12:00 p.m. ET / 5:00 p.m. - 6:00 p.m. CET

To register for the KOL webinar, please click here .

About SENS-401

SENS-401 (Arazasetron), Sensorion's lead clinical-stage drug candidate, is a small molecule that can be taken orally and is intended to protect and preserve the tissues of the inner ear against damage that can lead to loss of progressive or sequelae hearing. Sensorion is currently developing SENS-401 in a Phase 2a for the prevention of residual hearing loss in cochlear implant patients and in a Phase 2 clinical study in the prevention of cisplatin-induced ototoxicity. SENS-401 has been granted orphan drug designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss as well as by the FDA in the United States, in the prevention of platinum-induced ototoxicity in the pediatric population .

Proposals from Sensorion

Sensorion is a pioneering clinical-stage biotechnology company dedicated to developing innovative therapies to restore, treat and prevent hearing impairment, a significant unmet medical need.

Sensorion has developed a unique R&D platform to deepen its understanding of the pathophysiology and etiology of inner ear diseases, allowing it to select the best therapeutic targets and mechanisms of action suitable for its drug candidates.

Sensorion is developing, as part of the implementation of a broad strategic collaboration targeting the genetics of hearing with the Pasteur Institute, two gene therapy programs aimed at correcting hereditary monogenic forms of deafness. OTOF-GT targets hearing loss caused by mutations in the gene encoding otoferlin and GJB2-GT targets hearing loss caused by mutations in the GJB2 gene , to potentially treat large segments of hearing loss in adults and children . The company is also working on the identification of biomarkers in order to improve the diagnosis of these diseases that are little or badly treated.

Sensorion's portfolio also includes clinical-stage small molecule programs for the treatment and prevention of hearing disorders.

Its clinical-stage product portfolio includes a Phase 2 product: SENS-401 (Arazasetron) which is progressing in a Proof of Concept clinical study in cisplatin-induced ototoxicity (CIO), and in a study in partnership with Cochlear Limited, in patients to receive a cochlear implant. A Phase 2 study of SENS-401 in Sudden Sensorineural Hearing Loss (SSNHL) was also finalized in January 2022.

www.sensorion.com

Etiquette: SENSORION
ISIN: FR0012596468
Mnemonique: ALSEN

Warning

This release contains forward-looking statements regarding Sensorion and its business. Sensorion believes that these forward-looking statements are based on reasonable assumptions. However, no guarantee can be given as to the achievement of the forecasts expressed in these forward-looking statements which are subject to risks, including those described in the 2022 Annual Financial Report published on March 30, 2023 and available on the Company's website, and changes in economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements in this release are also subject to risks unknown to Sensorion or that Sensorion does not believe are material as of this date. The realization of all or part of these risks could cause the actual results, financial conditions, performances or achievements of Sensorion to differ materially from the results, financial conditions, performances or achievements expressed in these forward-looking statements. This press release and the information it contains do not constitute or be interpreted as an offer or an invitation to sell or subscribe, or the solicitation of any order or invitation to buy or subscribe to Sensorion shares in any country. The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons in possession of the press release must therefore inform themselves of any local restrictions and comply with them. Sensorion's performance or achievements differ materially from the results, financial conditions, performance or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute or be interpreted as an offer or an invitation to sell or subscribe, or the solicitation of any order or invitation to buy or subscribe to Sensorion shares in any country. The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons in possession of the press release must therefore inform themselves of any local restrictions and comply with them. Sensorion's performance or achievements differ materially from the results, financial conditions, performance or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute or be interpreted as an offer or an invitation to sell or subscribe, or the solicitation of any order or invitation to buy or subscribe to Sensorion shares in any country. The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons in possession of the press release must therefore inform themselves of any local restrictions and comply with them. This press release and the information it contains do not constitute or be interpreted as an offer or an invitation to sell or subscribe, or the solicitation of any order or invitation to buy or subscribe to Sensorion shares in any country. The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons in possession of the press release must therefore inform themselves of any local restrictions and comply with them. This press release and the information it contains do not constitute or be interpreted as an offer or an invitation to sell or subscribe, or the solicitation of any order or invitation to buy or subscribe to Sensorion shares in any country. The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons in possession of the press release must therefore inform themselves of any local restrictions and comply with them. The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons in possession of the press release must therefore inform themselves of any local restrictions and comply with them. The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons in possession of the press release must therefore inform themselves of any local restrictions and comply with them.

Contacts
Investor Relations Investors
Noemie Djokovic, Head of Investor Relations and Communication
ir.contact@sensorion-pharma.com

Ulysse Communication
Pierre-Louis Germain / +00 33 (0)6 64 79 97 51
plgermain@ulysse-communication.com

Bruno Arabian /+00 33 (0)6 87 88 47 26
barabian@ulysse-communication.com

Press relations
Consilium Strategic Communication
Jessica Hodgson/Sue Stuart/Isabelle Abdou
+44 7561 424788
sensorion@consilium-comms.com

 

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