{"id":50531,"date":"2022-11-07T08:02:45","date_gmt":"2022-11-07T07:02:45","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/sensorion-announces-us-fda-grants-rare-pediatric-disease-designation-to-otof-gt-for-the-treatment-of-otoferlin-gene-mediated-hearing-loss\/"},"modified":"2022-11-07T08:02:45","modified_gmt":"2022-11-07T07:02:45","slug":"sensorion-announces-us-fda-grants-rare-pediatric-disease-designation-to-otof-gt-for-the-treatment-of-otoferlin-gene-mediated-hearing-loss","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/sensorion-announces-us-fda-grants-rare-pediatric-disease-designation-to-otof-gt-for-the-treatment-of-otoferlin-gene-mediated-hearing-loss\/","title":{"rendered":"Sensorion Announces US FDA Grants Rare Pediatric Disease Designation to OTOF-GT for the Treatment of Otoferlin Gene-Mediated Hearing Loss"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>OTOF-GT targets the restoration of hearing in people living with otoferlin deficiency<\/i>\n<\/li>\n<li>\n<i>Sensorion is on track to file a CTA for OTOF-GT in H1 2023<\/i>\n<\/li>\n<\/ul>\n<p>MONTPELLIER, France&#8211;(BUSINESS WIRE)&#8211;Regulatory News:\n<\/p>\n<p>\n<b>Sensorion (FR0012596468 \u2013 ALSEN) <\/b>a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, announces that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to the Company\u2019s lead therapy gene candidate, OTOF-GT, a gene therapy intended for the treatment of otoferlin gene mediated hearing loss.\n<\/p>\n<p>\nSensorion\u2019s OTOF-GT gene therapy development program aims to restore hearing in people living with otoferlin deficiency, one of the most common forms of congenital deafness. The otoferlin protein is large and is delivered to the inner ear using two standard gene therapy vectors (AAV) and assembled in place. Patients with <i>OTOF<\/i> mutations suffer from severe to profound sensorineural prelingual non syndromic hearing loss. Otoferlin deficiency could be responsible for up to 8% of all cases of congenital hearing loss, around 20,000 people are affected in the United States and in Europe.<sup>1<\/sup>\n<\/p>\n<p>\nSensorion has progressed preclinical and clinical development plans for OTOF-GT and is on track to file a Clinical Trial Application (CTA) in the first half of 2023. In September 2022, the Company received a positive opinion on an application for Orphan Drug Designation (ODD) from the European Medicines Agency (EMA). The European Commission issued the decision on October 11, 2022.\n<\/p>\n<p>\n<i>\u201c<\/i>We are really pleased that the FDA has acknowledged the urgent need to develop solutions for this condition, for which there are currently no approved therapies. This important regulatory designation will support us in advancing this potentially transformative therapy to patients<i>,\u201d <\/i>said<i> <\/i><b>G\u00e9raldine Honnet, Chief Medical Officer of Sensorion<\/b><i>. \u201c<\/i>This is a key milestone for our important gene therapy franchise, which offers the potential for permanent solutions for these debilitating conditions and is increasingly central to Sensorion\u2019s strategic roadmap. The designation is another key piece in the puzzle that helps advance Sensorion towards clinical development in OTOF-GT in 2023<i>.\u201d<\/i>\n<\/p>\n<p>\nThe FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the United States.\n<\/p>\n<p>\nUnder this designation, a sponsor who receives an approval for a drug or biologic for a \u201crare pediatric disease\u201d may be eligible for a voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product or sold to another sponsor for priority review of their marketing application, an opportunity for which there is a robust market.\n<\/p>\n<p>\n<b>About Sensorion<\/b>\n<\/p>\n<p>\nSensorion 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.\n<\/p>\n<p>\nSensorion has built a unique R&amp;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. Its portfolio combines both small molecule programs and a preclinical portfolio of inner ear gene therapies.\n<\/p>\n<p>\nIts clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study 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.\n<\/p>\n<p>\nSensorion pursues its broad strategic collaboration with Institut Pasteur focused on the genetics of hearing. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness including OTOF-GT, targeting deafness caused by a mutation of the gene encoding for otoferlin, and hearing loss related to mutation in <i>GJB2<\/i> gene to potentially address important hearing loss segments in adults and children (GJB2-GT). The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.\n<\/p>\n<p>\n<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.sensorion.com&amp;esheet=52961717&amp;newsitemid=20221106005040&amp;lan=en-US&amp;anchor=www.sensorion.com&amp;index=1&amp;md5=f3b162f8ff1b331f00800ecd8b156bee\" rel=\"nofollow noopener\" shape=\"rect\">www.sensorion.com<\/a>\n<\/p>\n<p>\nLabel: <b>SENSORION<br \/>\n<br \/><\/b>ISIN: <b>FR0012596468<br \/>\n<br \/><\/b>Mnemonic: <b>ALSEN<\/b>\n<\/p>\n<p>\n<b>Disclaimer<\/b>\n<\/p>\n<p>\nThis 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 2021 full year financial report published on April 28, 2022, 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.\n<\/p>\n<p>\n____________________________<br \/>\n<br \/><sup>1<\/sup> Rodr\u00edguez-Ballesteros M, Reynoso R, Olarte M, Villamar M, Morera C, Santarelli R, Arslan E, Med\u00e1 C, Curet C, V\u00f6lter C, Sainz-Quevedo M, Castorina P, Ambrosetti U, Berrettini S, Frei K, Ted\u00edn S, Smith J, Cruz Tapia M, Cavall\u00e9 L, Gelvez N, Primignani P, G\u00f3mez-Rosas E, Mart\u00edn 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.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Investor Relations<\/b><br \/>Noemie Djokovic<br \/>\n<br \/>Investor Relations &amp; Communication<br \/>\n<br \/>+33 6 76 67 98 31<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#58;&#105;&#114;&#46;cont&#x61;&#x63;&#x74;&#x40;&#x73;&#x65;&#110;&#115;&#111;&#114;&#105;on-&#x70;&#x68;&#x61;&#x72;&#x6d;&#x61;&#46;&#99;&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">ir&#46;conta&#99;&#116;&#64;&#115;&#101;&#110;&#115;&#111;&#114;&#105;&#x6f;&#x6e;&#x2d;&#x70;&#x68;&#x61;&#x72;&#x6d;&#x61;&#x2e;&#x63;&#x6f;&#x6d;<\/a>\n<\/p>\n<p>\n<b>International Media Relations<\/b><br \/>Consilium Strategic Communications<br \/>\n<br \/>Matthew Cole\/Jessica Hodgson<br \/>\n<br \/>+44 7739 788014<br \/>\n<br \/>+44 7561 424788<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;t&#x6f;:&#83;&#x65;&#110;&#x73;o&#x72;i&#111;&#x6e;&#64;&#x63;o&#x6e;s&#105;&#x6c;&#105;&#x75;m&#x2d;c&#111;&#x6d;&#109;&#x73;&#46;&#x63;o&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x53;&#x65;&#x6e;&#x73;&#x6f;&#x72;&#x69;&#x6f;&#x6e;&#x40;&#x63;&#x6f;&#x6e;&#x73;&#x69;&#x6c;&#x69;&#x75;&#x6d;&#x2d;&#x63;&#x6f;&#x6d;&#x6d;&#x73;&#x2e;&#x63;&#x6f;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>OTOF-GT targets the restoration of hearing in people living with otoferlin deficiency Sensorion is on track to file a CTA for OTOF-GT in H1 2023 MONTPELLIER, France&#8211;(BUSINESS WIRE)&#8211;Regulatory News: Sensorion (FR0012596468 \u2013 ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, announces &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/sensorion-announces-us-fda-grants-rare-pediatric-disease-designation-to-otof-gt-for-the-treatment-of-otoferlin-gene-mediated-hearing-loss\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-50531","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Sensorion Announces US FDA Grants Rare Pediatric Disease Designation to OTOF-GT for the Treatment of Otoferlin Gene-Mediated Hearing Loss - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/sensorion-announces-us-fda-grants-rare-pediatric-disease-designation-to-otof-gt-for-the-treatment-of-otoferlin-gene-mediated-hearing-loss\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sensorion Announces US FDA Grants Rare Pediatric Disease Designation to OTOF-GT for the Treatment of Otoferlin Gene-Mediated Hearing Loss - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"OTOF-GT targets the restoration of hearing in people living with otoferlin deficiency Sensorion is on track to file a CTA for OTOF-GT in H1 2023 MONTPELLIER, France&#8211;(BUSINESS WIRE)&#8211;Regulatory News: Sensorion (FR0012596468 \u2013 ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, announces ... 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