Hearing Loss, Sudden

AC102 restores hearing in a preclinical model of sudden hearing loss by protecting inner ear neurons and their neuronal connections A Phase-2-clinical study evaluates the efficacy of AC102 in sudden hearing loss patients BERLIN--(BUSINESS WIRE)-- A single application of the novel compound AC102 almost completely restores noise-induced hearing loss in preclinical models. This is the key finding of a recent publication in the prestigious scientific journal PNAS by the Berlin-based start-up AudioCure Pharma. Sudden hearing loss is often treated with anti-inflammatory corticosteroids without regulatory approval or reliable evidence of effectiveness. Therefore, new treatment options are urgently needed for this condition. This press release features multimedia. View the full release here: Inner hair cells in the inner ear (picture: Nemes Laszlo/Shutterstock.com) Noise-induced hearing loss was used to evaluate the efficacy of AC102 in a preclinical model. A single middle ear application of AC102 after noise trauma restores hearing to near pre-trauma levels after 14 days. In contrast, treatment without the active compound resulted in a profound hearing loss. Further experiments show that AC102 targets the two suspected main causes of sudden hearing loss in the inner ear: It prevents the death of outer hair sensory cells and protects the connections between neurons and the auditory nerve. “It is fascinating how a single molecule has such diverse effects in the inner ear. In laboratory experiments, we see that AC102 protects neurons by increasing their energy production and reducing the production of free radicals. At the same time, it stimulates the regeneration of neurons and sensory cells enabling the reformation of lost connections,” explains Professor Hans Rommelspacher, CSO and founder of AudioCure Pharma. Sudden hearing loss is a debilitating condition that can severely impair speech understanding and have a negative impact on a patient's life. Corticosteroids have been used to treat this condition for 50 years, despite lack of approval. Also, their effectiveness has been questioned. Recently, a large study (HODOKORT) showed that more than 60% of patients with sudden hearing loss did not fully recover after corticosteroid treatment. Dr. Reimar Schlingensiepen, CEO of AudioCure Pharma, explains, "The HODOKORT study highlights the treatment gap for sudden hearing loss. We are therefore very excited about the promising effects of AC102 in our preclinical models and hope that patients will also benefit from it." Following successful safety and tolerability testing, AC102 is currently being evaluated for efficacy in a pan-European Phase 2 clinical study in patients with sudden hearing loss. View source version on businesswire.com: Contacts AudioCure Pharma GmbH Frauke Luers Phone: +49 30 2218 397-0 E-Mail: pr@ac-clinical.com Web: Source: AudioCure Pharma GmbH Smart Multimedia Gallery Photo Inner hair cells in the inner ear (picture: Nemes Laszlo/Shutterstock.com) Logo View this news release and multimedia online at:

MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: Sensorion (FR0012596468 – ALSEN) (Paris:ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces the publication of the March 2024 Letter to Shareholders. Read the Letter to Shareholders by clicking here. The Letter is being made available on Sensorion’s website ( ), in the financial information section. About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2023 full year financial report published on March 14, 2024, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. View source version on businesswire.com: Contacts Investor Relations Noémie Djokovic, Investor Relations and Communications Associate ir.contact@sensorion-pharma.com Press Relations Ulysse Communication Pierre-Louis Germain / 00 33 (0)6 64 79 97 51 plgermain@ulysse-communication.com Bruno Arabian / 00 00(0)6 87 88 47 26 barabian@ulysse-communication.com Source: Sensorion View this news release online at:

MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces its participation in the Bioprocessing Summit Europe, taking place on March 19-21, 2024, in Barcelona, Spain. Christine Le Bec, PhD, Head of CMC Gene Therapy, will chair a session entitled “Advancing Technical Development of Gene Therapies”, on March 19, 2024, at 8.25am CET (3.25am EDT). Christine will also make the following presentation “Manufacturing Challenges and Control Strategies for Dual AAV Vectors”, on March 19, 2024, at 2.50pm CET (9.50am EDT). About Sensorion Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, a significant global unmet medical need. Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) currently being developed in a Phase 1/2 clinical trial, targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022. Label: SENSORION ISIN: FR0012596468 Mnemonic: ALSEN Disclaimer This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2022 full year financial report published on March 30, 2023, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. View source version on businesswire.com: Contacts Investor Relations Noémie Djokovic, Investor Relations and Communications Associate ir.contact@sensorion-pharma.com Press Relations Ulysse Communication Pierre-Louis Germain / 00 33 (0)6 64 79 97 51 plgermain@ulysse-communication.com Bruno Arabian / 00 00(0)6 87 88 47 26 barabian@ulysse-communication.com Source: Sensorion View this news release online at: