Latest news with #Sensorion
Yahoo
13-05-2025
- Business
- Yahoo
Sensorion Publishes Results of Combined Shareholders' General Meeting Resolutions
MONTPELLIER, France, May 13, 2025--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced the results of resolutions presented at its Combined General Meeting (CGM), held on May 12, 2025, and made them available on the dedicated section of its website. All resolutions recommended by the Board and submitted to the Combined General Meeting were adopted. 81.7% of the capital was present and represented. The results of the votes on all proposed resolutions can be found on Sensorion's website ( in the Investors section under the Governance tab. 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 programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion's small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation 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: SENSORIONISIN: FR0012596468Mnemonic: 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 2024 full year report published on March 14, 2025, 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 Contacts Investor Relations Noémie Djokovic, Investor Relations and Communication Press Relations Ulysse CommunicationBruno Arabian / 00 33(0)6 87 88 47 26barabian@ Nicolas Entz / 00 33 (0)6 33 67 31 54nentz@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
06-05-2025
- Business
- Business Wire
Sensorion Announces its Participation in the American Society of Cell and Gene Therapy (ASGCT) Annual Meeting
MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today announced its participation at the 28 th Annual American Society of Cell and Gene Therapy Meeting (ASGCT), taking place on May 13-17, 2025, in New-Orleans, United States of America. On this occasion, Rafik Boudra, Preclinical Group Leader Technology & Innovation Platform at Sensorion, will present the 2 following posters on May 15, 2025: Poster N°1556 Title: Safety and efficacy of GJB2-GT, an adeno associated viral vector-based gene therapy treatment candidate for the autosomal recessive non-syndromic deafness 1A (DFNB1A) Poster N° 1559 Title: GJB2 gene therapy-response of two pre-clinical mouse models of the most frequent form of human deafness, DFNB1A This poster is presented in collaboration with the Auditory Therapies Innovation Laboratory headed by Professor Christine PETIT at Hearing Institute, research center of the Institut Pasteur Date: May 15, 2025 Time: 5.30 pm - 7.00 pm CT Room: Morial Convention Center, Poster Hall, Hall I2 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 programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion's small molecule progresses in a Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing. Sensorion, with partner Cochlear Limited, completed in 2024 a Phase 2a study of SENS-401 for the residual hearing preservation 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. 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 2024 full year report published on March 14, 2025, 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.
Associated Press
14-03-2025
- Business
- Associated Press
Sensorion Reports Full-Year 2024 Results, Provides Corporate Update and Announces Availability of Full-Year Report
Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company specializing in the development of novel therapies to restore, treat and prevent hearing loss disorders, today reported its full-year 2024 results, provided a corporate update, and announced the availability of the full-year report. 'This past year has been an exceptional period of progress on clinical and corporate development fronts,' commented Nawal Ouzren, Chief Executive Officer of Sensorion. 'Our portfolio of next generation treatments for hearing loss disorders achieved important development milestones highlighted by the first cohort being enrolled in Audiogene, our first gene therapy clinical trial, and with SENS-401's Phase 2a POC study meeting its primary and secondary endpoints in preserving residual hearing following cochlear implantation. On the operational side, we executed two successful financings totaling over €65 million which enabled us to maintain development pace for the entire pipeline of programs while welcoming some of the healthcare sector's leading institutional investors to the registry. We head into 2025 well positioned to execute on our clinical and corporate growth plan and on behalf of the entire team, I extend gratitude to our longstanding shareholders, to the patients and to the doctors for their continued support as we remain steadfast in bringing to market disruptive treatments for hearing loss disorders.' Pipeline Highlights and Upcoming Milestones Gene Therapies for Hereditary Monogenic Hearing Loss In 2024, Sensorion advanced its portfolio of gene therapies developed in collaboration with the Institut Pasteur. The Company achieved several notable milestones with lead candidate SENS-501, for the treatment of hearing loss caused by otoferlin deficiency. SENS-501: Gene therapy program to restore hearing in OTOF patients Sensorion's SENS-501 dual vector AAV (adeno-associated virus) gene therapy development product aims at restoring hearing in patients with mutations in OTOF gene who suffer from severe to profound sensorineural prelingual non syndromic hearing loss. Otoferlin related hearing loss is responsible for up to 8% of all cases of congenital hearing loss, with around 20,000 people affected in the US and Europe 1. On January 19, 2024, Sensorion announced the approval to initiate the Phase 1/2 gene therapy clinical trial of SENS-501, Audiogene. The study design consists of two cohorts of two doses followed by an expansion cohort at the selected dose. Safety will be the primary endpoint for the dose escalation cohort, and the auditory brainstem response (ABR) will be the primary efficacy endpoint of the dose expansion cohort. Audiogene will also assess the clinical safety, performance, and usability of the administration device system developed by Sensorion. Additionally, Sensorion received the European Medicines Agency's decision agreeing on a Pediatric Investigation Plan (PIP) for SENS-501, in September 2024. In September 2024, Sensorion reported the injection of the first patient recruited in the Audiogene trial, and, during the symposium it held during the World Congress of Audiology, reported initial safety data of the first patient. On December 27, 2024, Sensorion announced the patient recruitment completion of the first cohort of patients in the Audiogene study, with all first three toddlers and infants having received an injection of the gene therapy product, SENS-501. On February 21, 2025, Sensorion received a positive recommendation from the Data Monitoring Committee of Audiogene, after reviewing the first cohort tolerability and safety data. Sensorion plans on completing the recruitment of the second cohort of patients and on hosting a KOL event to present new data in H1 2025. GJB2-GT: Gene therapy program to restore hearing in GJB2 patients Sensorion's AAV-based GJB2 gene therapy program developed in collaboration with the Institut Pasteur, has the potential to address three pathologies related to GJB2 mutations: pediatric congenital deafness, progressive forms of hearing loss in children, and early onset of presbycusis in adults. The Company provided GJB2-GT Proof-of-Concept data at the European Society of Cell & Gene Therapy (ESGCT), which took place on October 22-25, 2024, Rome, Italy. Sensorion is advancing the candidate into CTA/IND-enabling activities for anticipated submission in Q1 2026. SENS-401, Sensorion's small molecule for the treatment and prevention of hearing loss SENS-401 (Arazasetron) is a small molecule that Sensorion develops in three indications: (i) to treat Sudden Sensorineural Hearing Loss SSNHL (Phase 2b completed), (ii) to preserve residual hearing following cochlear implantation (Phase 2a completed), and (iii) to prevent Cisplatin-Induced Ototoxicity (Phase 2a ongoing). SENS-401 is an orally available small molecule that aims at protecting and preserving inner ear tissue from damage, responsible for hearing impairment. SENS-401 has been granted Orphan Drug Designation in Europe for the treatment of SSNHL, and in the U.S. for the prevention of Cisplatin-Induced Ototoxicity in pediatric population. The Company is conducting strategic business discussions to partner it small molecule, SENS-401. SENS-401 to preserve residual hearing after cochlear implantation Sensorion's Phase 2a Proof of Concept clinical trial of SENS-401 in patients scheduled for a cochlear implantation was a multicentric, randomized, controlled open-label trial aimed at evaluating the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult patients prior to cochlear implantation due to moderately severe to profound hearing impairment. Patients started treatment with SENS-401 7 days before implantation and continued to receive SENS-401 for a further 42 days. This study was developed in collaboration with Cochlear Limited, the global leader in implantable hearing solutions. On February 1, 2024, Sensorion announced the completion of patient inclusion in the Phase 2a POC clinical trial. On March 11, 2024, Sensorion announced that the primary endpoint of assessing the presence of SENS-401 in the inner ear perilymph at a level sufficient to elicit a therapeutic benefit was met in 100% of the patients sampled, 7 days after the start of the treatment. On September 20, 2024, study investigator Professor Stephen O'Leary, M.D., Ph.D., during a symposium organized by Sensorion at the World Congress of Audiology, and Professor Christophe Vincent in a dedicated session on auditory implants for adults, reported analysis of Sensorion's final data of SENS-401. After 7 weeks of treatment with SENS-401 (and 6 weeks after cochlear implantation), the reduction in residual hearing loss was systematically better at the 3 frequencies 250, 500 & 750Hz in the group treated with SENS-401. This protective effect was maintained 8 weeks after cessation of treatment (14 weeks after cochlear implantation). The results show that patients treated with SENS-401 have 'complete' hearing preservation (40% of patients) compared with the control group (0% of patients) according to the Skarzynski index. In addition, the favorable safety profile of SENS-401 has been validated, in line with previous studies on SENS-401. SENS-401 to prevent Cisplatin-Induced Ototoxicity (CIO) Cisplatin and other platinum-based compounds are essential chemotherapeutic agents in the treatment of many cancers. A serious side effect of these therapies is ototoxicity, permanent and irreversible hearing loss, which occurs in 40 to 60% 2 of adult and pediatric patients treated. This indication represents a significant unmet medical need for patients and constitutes a potential large global market. The Phase 2a Proof-of-Concept (POC) NOTOXIS trial is a multicenter, randomized, controlled, open-label study, designed to evaluate the efficacy of SENS-401 to prevent ototoxicity induced by cisplatin in adult patients with a neoplastic disease 4 weeks after the completion of cisplatin-based chemotherapy. The trial assesses several outcome measures, including the rate and severity of ototoxicity, the change from baseline in Pure Tone Audiometry (PTA) (dB) throughout the study and the tolerance. On July 23, 2024, Sensorion announced a positive recommendation from the Data Safety Monitoring Board (DSMB) regarding the continuation of NOTOXIS. On September 20, 2024, Professor Yann Nguyen reported preliminary safety and efficacy data in Sensorion's NOTOXIS trial, during the World Congress of Audiology. The preliminary data show that a cumulative dose of cisplatin is a key factor of ototoxicity severity. A good safety profile of SENS-401 is confirmed in the long term, with the drug being administered for the first time for an average duration of up to 23 weeks. The preliminary results suggest a trend toward an otoprotective effect of SENS-401 beyond a cisplatin dose of 300 mg/m2. Despite significant exposure to cisplatin in the treatment group, most participants showed only mild ototoxicity. On March 7, 2025, the Company announced the end of patient enrollment in NOTOXIS, its Phase 2a POC clinical trial of SENS-401 in Cisplatin-Induced Ototoxicity. Sensorion plans on reporting the topline data by the end of 2025. Strengthening the Board of Directors and senior leadership On January 25, 2024, Sensorion announced the nomination of Dr. Federico Mingozzi as board member. Dr. Federico Mingozzi has previously worked at Spark Therapeutics, where he served as Chief Science and Technology Officer. Federico brings over 25 years of experience in gene therapy, immunology, as well as biochemistry and molecular biology in academia and industry. He is well known for his significant contributions to the development of gene therapies for the treatment of various diseases. Furthermore, he has played a key role in advancing the understanding of the interactions between gene therapy vectors and the host immune system, as well as in the formulation of strategies to overcome immune responses to anti-AAV vectors. On June 27, 2024, Sensorion appointed Laurene Danon as Chief Financial Officer. Laurene brings to Sensorion more than 15 years of experience in investment banking and international equity capital markets. A graduate of HEC, she began her career in London with the investment bank J.P. Morgan in a corporate finance advisory capacity, before specializing in equity capital markets at J.P. Morgan and later at Jefferies International. Prior to joining Sensorion, she founded the strategic advisory firm Concorde Advisory, where she supported and managed the execution of strategic corporate finance projects for her clients. In total, Laurene has led executions for 70 transactions totalling over $35 billion raised. Expected future milestones and estimated timelines H1 2025 – SENS-501: Enrollment completion of the second cohort of patients in Audiogene trial and KOL event to present new data H2 2025 – SENS-401 in Cisplatin-Induced Ototoxicity: Topline results Q1 2026 – GJB2-GT: Clinical Trial Applications filing Full Year 2024 financial highlights Cash Position Cash & Cash Equivalents, and short-term deposits, amounted to c. €77m as of December 31, 2024, compared to €37.0m as of December 31, 2023. R&D expenses increased by 13 % from €22.8 million in 2023 to €25.7 million in 2024. General And Administrative (G&A) Expenses G&A expenses were €9.4 million for 2024, compared to €5.3 million for 2023. Net Loss Net loss was -€26.0million for 2024, compared to -€22.1 million for 2023. Financial guidance Based on cash and cash equivalents and short-term deposit classified in other current assets of €77.0 million at 31 December 204, the Company has sufficient net working capital to meet its cash requirements until the end of Q1 2026. Financial results The annual accounts as at December 31, 2024, were prepared according to IFRS standards and approved by the Board of Directors on March 13, 2025. The simplified income statement as of December 31, 2024, is as follows: In thousands of Euros – IFRS standards 31.12.2024 31.12.2023 Operating income 6,653 5,698 Research & Development expenses -25,664 -22,755 General & Administrative expenses -9,390 -5,253 Total operating expenses -35,054 -28,009 Operating loss -28,401 -22,310 Financial result 2,555 544 Corporate Income Tax -126 -297 Net loss -25,972 -22,063 The simplified balance sheet as of December 31, 2024, is as follows: In thousands of Euros – IFRS standards 31.12.2024 31.12.2023 Non-current Assets 3,574 3,236 Other Current Assets 18,934 6,292 Of which short term deposit 10 214 Cash & cash equivalent 66,769 36,974 Total Assets 89,277 46,502 Equity 72,138 33,275 Non-current Liabilities 3,486 3,646 Current Liabilities 13,653 9,581 Total Liabilities 89,277 46,502 2024 certified accounts On March 13, 2025, the Board of Directors approved the Company's full year results as of December 31, 2024. The Full Year Report can be found on Sensorion's website ( in the investor section under financial information. The full year accounts of 2024 have been subject to a limited review by the Company's statutory auditors and an unqualified report is being issued. About SENS-501 SENS-501 (OTOF-GT) is an innovative gene therapy program developed to treat a specific form of congenital deafness linked to mutations in the OTOF (otoferlin) gene. This gene plays a key role in the transmission of auditory signals between the hair cells of the inner ear and the auditory nerve. When this gene is defective, affected individuals are born with severe to profound hearing loss. The aim of SENS-501 (OTOF-GT) is to restore hearing by introducing a functional copy of the OTOF gene directly into hair cells via viral vector technology (AAV). This therapy aims to restore the normal process of converting sound into electrical signals, enabling patients to regain their hearing ability. Currently in the clinical research phase, this gene therapy program represents significant hope for families affected by this rare form of genetic deafness. SENS-501 (OTOF-GT) embodies a commitment to scientific innovation in the field of hearing, with the potential to dramatically improve the quality of life of patients suffering from genetic deafness. This gene therapy for patients suffering from otoferlin deficiency has been developed in the framework of RHU AUDINNOVE, a consortium composed of Sensorion with the Necker Enfants Malades Hospital, the Institut Pasteur, and the Fondation pour l'Audition. The project is partially financed by the French National Research Agency, through the 'investing for the future' program (ref: ANR-18-RHUS-0007). About the Audiogene Trial Audiogene aims to evaluate the safety, tolerability and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing loss in infants and toddlers aged 6 to 31 months at the time of gene therapy treatment. By targeting the first years of life, when brain plasticity is optimal, the chances of these young children with pre-linguistic hearing loss acquiring normal speech and language are maximized. The study comprises two cohorts of two doses followed by an expansion cohort at the selected dose. While safety will be the primary endpoint of the first part of the dose escalation study, auditory brainstem response (ABR) will be the primary efficacy endpoint of the second part of the expansion. Audiogene will also evaluate the clinical safety, performance and ease-of-use of the delivery system developed by Sensorion. About SENS-401 SENS-401 (Arazasetron), Sensorion's clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion developed SENS-401 in three Phase 2 clinical trials: (i) for the prevention of Cisplatin-Induced Ototoxicity, (ii) to prevent residual hearing loss in patients scheduled for cochlear implantation, and (iii) to treat sudden sensorineural hearing loss. The last two studies are completed. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population. 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 programs of a clinical-stage small molecule, SENS-401 (Arazasetron), for the treatment and prevention of hearing loss disorders. Sensorion's small molecule progressed in three Phase 2 proof of concept clinical study: firstly, in Cisplatin-Induced Ototoxicity (CIO) for the preservation of residual hearing, for which the recruitment is completed and the follow-up is ongoing. Secondly, with partner Cochlear Limited, a study of SENS-401 for the residual hearing preservation in patients scheduled for cochlear implantation, completed in 2024. Thirdly, a Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in 2022. Label: SENSORION 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 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. 1 Rodríguez-Ballesteros M, Reynoso R, Olarte M, Villamar M, Morera C, Santarelli R, Arslan E, Medá C, Curet C, Völter C, Sainz-Quevedo M, Castorina P, Ambrosetti U, Berrettini S, Frei K, Tedín S, Smith J, Cruz Tapia M, Cavallé L, Gelvez N, Primignani P, Gómez-Rosas E, Martín M, Moreno-Pelayo MA, Tamayo M, Moreno-Barral J, Moreno F, del Castillo I. A multicenter study on the prevalence and spectrum of mutations in the otoferlin gene (OTOF) in subjects with nonsyndromic hearing impairment and auditory neuropathy. Hum Mutat. 2008 Jun;29(6):823-31. doi: 10.1002/humu.20708. PMID: 18381613. 2 JCO Oncology practice, ASCO, volume 19, Issue 5/ CIO: a concise review of the burden, prevention and interception strategies, May 2024 Chattaraj. [email protected] Press Relations Bruno Arabian / 00 33(0)6 87 88 47 26 [email protected] Nicolas Entz / 00 33 (0)6 33 67 31 54 [email protected] KEYWORD: EUROPE UNITED STATES NORTH AMERICA FRANCE INDUSTRY KEYWORD: HEALTH GENETICS RESEARCH PHARMACEUTICAL SCIENCE BIOTECHNOLOGY SOURCE: Sensorion Copyright Business Wire 2025. PUB: 03/14/2025 02:30 AM/DISC: 03/14/2025 02:29 AM
Associated Press
12-02-2025
- Business
- Associated Press
Sensorion Announces its Participation in the Association for Research in Otolaryngology ARO 48th Annual Midwinter Meeting
Regulatory News: Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent loss disorders, today announces its participation in the Association for Research in Otolaryngology (ARO) 48 th Annual Midwinter Meeting, taking place on February 22-26, 2025, in Orlando, Florida, USA. Laurent Désiré, Ph.D., Head of Preclinical Development at Sensorion, and the team of Professor Christine Petit, Professor at the Hearing Institute, an Institut Pasteur center, at the IHU reConnect, and Professor Emeritus at the Collège de France, Winner of the Kavli Prize in 2018, will co-present the following posters during the ARO meeting: Presentation type: Poster Presentation Title: GJB2-GT, a Novel Adeno Associated Vector-Based Gene Therapy as a Treatment for the Autosomal Recessive Non-Syndromic Deafness 1A (DFNB1A) Date: Sunday, February 23, 2025 Time: 1.30pm – 3pm ET Room: Peninsula Ballroom Presentation type: Poster Presentation Title: GJB2 Gene Therapy-Response of Two Pre-Clinical Mouse Models of the Most Frequent Form of Human deafness, DFNB1 Date: Sunday, February 23, 2025 Time: 1.30pm – 3pm ET Room: Peninsula Ballroom 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. 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, has completed 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 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 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. 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 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. [email protected] Relations Ulysse Communication Bruno Arabian / 00 33(0)6 87 88 47 26 [email protected] Entz / 00 33 (0)6 33 67 31 54 [email protected] KEYWORD: EUROPE UNITED STATES NORTH AMERICA FRANCE FLORIDA SOURCE: Sensorion Copyright Business Wire 2025. PUB: 02/12/2025 05:30 AM/DISC: 02/12/2025 05:29 AM
Globe and Mail
06-02-2025
- Health
- Globe and Mail
Hearing Loss Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight
DelveInsight's, 'Hearing Loss Pipeline Insight' report provides comprehensive insights about 32+ companies and 35+ pipeline drugs in Hearing Loss pipeline landscape. It covers the Hearing Loss pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hearing Loss therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Stay ahead with the latest insights! Download DelveInsight's comprehensive Hearing Loss Pipeline Report to explore emerging therapies, key Hearing Loss Companies, and future Hearing Loss treatment landscapes @ Hearing Loss Pipeline Outlook Report Key Takeaways from the Hearing Loss Pipeline Report In January 2025:- AudioCure Pharma GmbH- The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL). In January 2025:- Laboratoires Thea:- The purpose of this Phase 2b study is to evaluate the safety and tolerability of Ultevursen administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene. This is a multicenter Double-masked, Randomized, Sham-controlled study which will enroll 81 subjects. In January 2025:- Akouos Inc.:- This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance. DelveInsight's Hearing Loss pipeline report depicts a robust space with 32+ active players working to develop 35+ pipeline therapies for Hearing Loss treatment. The leading Hearing Loss Companies such as Acousia Therapeutics, Decibel Therapeutics, Otonomy Inc., Sensorion, Autifony Therapeutics, Auris Medical, Sound Pharmaceuticals, Anida Pharma Inc., Gateway Biotechnology, Myrtelle Inc., Lineage Cell Therapeutics, Inc., Altamira Therapeutics, Hoba Therapeutics, Rinri Therapeutics, Autifony Therapeutics, Otologic Pharmaceutics, Audion Therapeutics, Perha Pharmaceuticals, Applied Genetic Technologies Corporation, Akouos, Inc., Oricula Therapeutics, Spiral Therapeutics, Pipeline Therapeutics, Prime Medicine, Boehringer Ingelheim, Autigen, Heyu (Suzhou) Pharmaceutical Technology Co., Ltd, Astellas Pharma, Mogrify Limited and others. Promising Hearing Loss Therapies such as AM-111, FX-322, AUT00063, FX-322 (One Dose), AC102 Gel, Prednisolone, OTO-413, andothers. Discover how the Hearing Loss treatment paradigm is evolving. Access DelveInsight's in-depth Hearing Loss Pipeline Analysis for a closer look at promising breakthroughs @ Hearing Loss Clinical Trials and Studies Hearing Loss Emerging Drugs Profile SENS-401: Sensorion SENS-401 (Arazasetron), Sensorion's clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion is currently developing SENS-401 in a Phase IIa clinical trial for the prevention of residual hearing loss in patients scheduled for cochlear implantation, and in a Phase II clinical trial for 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, and by the FDA in the US for the prevention of platinum-induced ototoxicity in pediatric population. It is currently being evaluated in Phase II/III stage of development. ACOU085: Acousia Therapeutics ACOU085 is a proprietary small-molecule drug candidate under clinical development, with a particular focus on its use as an etiology-agnostic otoprotectant for patients with acute forms of sensorineural hearing loss. The company has successful completed Phase Ib study, following the final visit of the last patient treated with the highest ACOU085 dose. The next step is a clinical Phase II study using ACOU085 to protect the inner ears of testicular cancer patients undergoing chemotherapy from cisplatin-induced ototoxicity. It will be initiated in early 2023. OTO-413: Otonomy Inc. OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies have demonstrated that local administration of BDNF repairs the connections between inner hair cells and auditory nerve fibers in the cochlea that are damaged due to noise trauma or exposure to ototoxic chemicals. Furthermore, Otonomy has demonstrated in preclinical studies that repair of synaptic connections is associated with a restoration of hearing function. Initial clinical studies have demonstrated that a single intratympanic injection of OTO-413 is well-tolerated and improves hearing function across multiple clinically validated speech-in-noise hearing tests. Currently, the drug is being evaluated in the Phase I/II stage of development. DB-020: Decibel Therapeutics DB-020 is a proprietary formulation of sodium thiosulfate (STS) optimized for local delivery to the ear and is being investigated for its potential to protect against cisplatin-induced hearing loss without impacting the beneficial effect of cisplatin. DB-020 is designed to achieve high cochlear concentrations of STS following a local injection through the ear drum, or transtympanically, into the middle ear. Transtympanic injection is a brief, minimally invasive, routine, office-based procedure performed by ENTs and is generally well-tolerated. A randomized, double-blind, placebo-controlled Phase I clinical trial of DB-020 in normal healthy volunteers was completed in 2019. A randomized, double-blind, placebo-controlled, multicenter Phase Ib clinical trial of DB-020 in patients undergoing treatment with cisplatin is ongoing. DB-020 has been granted Fast Track designation by the US Food and Drug Administration (FDA). DB-020 is an investigational therapy for the prevention of cisplatin-induced hearing loss, a serious and debilitating condition for which there are no currently approved therapies. Currently, the drug is in the Phase I stage of development. Hearing Loss Companies Acousia Therapeutics, Decibel Therapeutics, Otonomy Inc., Sensorion, Autifony Therapeutics, Auris Medical, Sound Pharmaceuticals, Anida Pharma Inc., Gateway Biotechnology, Myrtelle Inc., Lineage Cell Therapeutics, Inc., Altamira Therapeutics, Hoba Therapeutics, Rinri Therapeutics, Autifony Therapeutics, Otologic Pharmaceutics, Audion Therapeutics, Perha Pharmaceuticals, Applied Genetic Technologies Corporation, Akouos, Inc., Oricula Therapeutics, Spiral Therapeutics, Pipeline Therapeutics, Prime Medicine, Boehringer Ingelheim, Autigen, Heyu (Suzhou) Pharmaceutical Technology Co., Ltd, Astellas Pharma, Mogrify Limited and others. Hearing Loss pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Hearing Loss Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Download DelveInsight's latest report to gain strategic insights into upcoming therapies and key developments @ Hearing Loss Market Drivers and Barriers, and Future Perspectives Scope of the Hearing Loss Pipeline Report Coverage- Global Hearing Loss Companies- Acousia Therapeutics, Decibel Therapeutics, Otonomy Inc., Sensorion, Autifony Therapeutics, Auris Medical, Sound Pharmaceuticals, Anida Pharma Inc., Gateway Biotechnology, Myrtelle Inc., Lineage Cell Therapeutics, Inc., Altamira Therapeutics, Hoba Therapeutics, Rinri Therapeutics, Autifony Therapeutics, Otologic Pharmaceutics, Audion Therapeutics, Perha Pharmaceuticals, Applied Genetic Technologies Corporation, Akouos, Inc., Oricula Therapeutics, Spiral Therapeutics, Pipeline Therapeutics, Prime Medicine, Boehringer Ingelheim, Autigen, Heyu (Suzhou) Pharmaceutical Technology Co., Ltd, Astellas Pharma, Mogrify Limited and others. Hearing Loss Therapies- AM-111, FX-322, AUT00063, FX-322 (One Dose), AC102 Gel, Prednisolone, OTO-413, andothers. Hearing Loss Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Hearing Loss Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Which companies are leading the race in Hearing Loss drug development? Find out in DelveInsight's exclusive Hearing Loss Pipeline Report—access it now! @ Hearing Loss Emerging Drugs and Major Companies Table of Content Introduction Executive Summary Hearing Loss: Overview Pipeline Therapeutics Therapeutic Assessment Hearing Loss– DelveInsight's Analytical Perspective Mid Stage Products (Phase II/III) SENS-401: Sensorion Drug profiles in the detailed report….. Early Stage Products (Phase I/II) OTO-413: Otonomy Inc. Drug profiles in the detailed report….. Early Stage Products (Phase I) ACOU085: Acousia Therapeutics Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Research programme: Hearing Loss: Autifony Therapeutics Drug profiles in the detailed report….. Inactive Products Hearing Loss- Unmet Needs Hearing Loss- Market Drivers and Barriers Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 9650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
