MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN / PEA-PME eligible) a pioneering clinical-stage biotech company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces that the French government has awarded the PATRIOT consortium a Structuring Research and Development Project for Competitiveness (“Projet de recherche et développement Structurant pour la Compétitivité” - PSPC) non-dilutive funding. This grant will be used to finance the development of SENS-401 in SSNHL, including work by Institut Pasteur to identify response biomarkers. This project fits with the spirit of the strategic collaboration established between Sensorion and Institut Pasteur and announced on the 27th of May 2019. The financing is conditioned upon the execution of a financing agreement with Bpifrance within three months.
The PATRIOT consortium consists of Sensorion, the French Army Biomedical Research Center (IRBA), Institut Pasteur and Electronique du Mazet1, a French MedTech company focusing on hearing assessment and diagnostics. This project structures collaborative research and development to respond to a high unmet medical need and contributes to the development of SENS-401 as a treatment option, up to regulatory approval.
The commitment and active involvement of the French ministry of Armed Forces to this project emphasizes on a clear unmet medical need and on the necessity to have efficient diagnostics and therapeutic solutions. Auditory deficit is an invisible injury causing disabilities and potential social isolation. An epidemiological surveillance report from the French armed forces’ epidemiology and public health center revealed that 62% of military personnel suffered from hearing loss following an acute noise trauma over the 2014-2016 period.2
The participation of the French Army in the Phase 2 study represents the largest military trial ever conducted in France. It will be carried out in multiple military sites where patients will be recruited according to the protocol approved by an ethics committee.
“We are extremely pleased to have the support of the French ministry of Armed Forces and the involvement of military personnel in our ongoing Phase 2 study. We believe their involvement significantly de-risks the overall study and increases the quality of the data we can collect. The project will receive €10.8m non-dilutive funding, staged over five years. Sensorion will receive €5.6m over the duration of the project,” says Nawal Ouzren, CEO of Sensorion.
SENS-401 (Arazasetron), is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment. A small molecule that can be taken orally or via an injection, SENS-401 has received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss, and Orphan Drug Designation from the US FDA for the prevention of platinum-induced ototoxicity in pediatric population. It has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).
About SENS-401 Phase 2 trial
The AUDIBLE-S Phase 2 is a multi-center, randomized, double-blind, placebo-controlled study of SENS-401 in subjects with severe or profound sudden sensorineural hearing loss (SSNHL). Included patients will receive twice a day for 4 weeks one of the following: a 43,5mg dose of SENS-401, a 29mg dose of SENS-401 or a placebo. The primary endpoint is change in pure tone audiometry PTA (dB) in the affected ear from baseline to the end of treatment visit (day 28).
Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL). 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 modalities for drug candidates. The Company has also identified biomarkers to improve diagnosis and treatment of these underserved illnesses. Sensorion has launched in the second half of 2019 two preclinical gene therapy programs aiming at correcting hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin. The Company is uniquely placed through its platforms and pipeline of potential therapeutics to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders; a significant global unmet medical need.
Ticker symbol: ALSEN
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 "Document de reference" registration document filed with the "Autorité des Marchés Financiers" (AMF French Financial Market Authority) on September 7th, 2017 under n°R.17-062 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 Through its subsidiary named ECHODIA
2 Traumatismes sonores aigus dans les armées - Résultats de la surveillance épidémiologique 2014-2016 – Centre d’épidémiologie et de santé des armées – July 12, 2018