MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (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, announces it plans to initiate a proof-of-concept clinical trial of SENS-401 to treat CIO in H2 2021. The Company also expects to start a natural history clinical study in CIO in adult cancer patients in H1 2021.
“SENS-401 has demonstrated highly encouraging efficacy in preclinical models and we are excited to progress this small molecule towards clinical trials to address this significant unmet medical need in cancer patients undergoing cisplatin treatment. Hearing loss caused by this chemotherapeutic treatment leads to permanent inner ear problems in 50-60% of cases, significantly impacting patients’ quality of life1. We look forward to further investigating the potential of SENS-401 to prevent this life-altering condition” says Géraldine Honnet, Chief Medical Officer of Sensorion.
An estimated 500,000 people will suffer from CIO in G7 countries by 2025 causing hearing loss, tinnitus and dizziness2. A critical requirement of any potential treatment for CIO is that it should not interfere with the efficacy of cisplatin, a potential differentiating feature of SENS-401. The natural history study will generate data on the course of hearing loss from CIO and contribute to the recruitment for the clinical study. Further details on the trial design will be communicated in H2 2021.
SENS-401 is a 5-HT3 receptor antagonist and calcineurin inhibitor which has been shown to siginificantly reduce hearing loss from CIO in preclinical models3. The use of SENS-401 has led to the survival of substantially more outer hair cells compared to placebo. Outer hair cells are the most vulnerable sensory cells in the inner ear which help amplify sound signals to increase hearing sensitivity. SENS-401 is also in Phase 2 development for the treatment of Sudden Sensorineural Hearing Loss (SSNHL).
Due to the impact of COVID-19, including the reinitiation of strict lockdown measures in some of the countries involved, Sensorion now expects a further delay in the availability of topline results from the Phase 2 study of SENS-401 in SSNHL. Topline data are now anticipated in Q4 2021 rather than mid-2021 as had been previously estimated. Sensorion continues to review this study and consider opportunities which could aid in its successful completion despite the challenges provided by COVID-19 and its knock-on effects.
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: SENS401 (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 is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. In the second half of 2019, Sensorion initiated two preclinical gene therapy programs aimed 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 potentially 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.
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 2020 Half-Year financial report published on October 21, 2020 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 B-ENT, 2017, 13, 85-92, Early detection of platinum-induced ototoxicity in adults E. D’heygere, R. Kuhweide, H. Pottel, L. Mus, T. Vauterin, and Bob Lerut.
2 Company estimates based on publicly available data in the US, Japan, Germany, France, UK, Italy and Spain
3 Oral Administration of Clinical Stage Drug Candidate SENS-401 Effectively Reduces Cisplatin-induced Hearing Loss in Rats. Petremann M, Tran Van Ba C, Broussy A, Romanet C, Dyhrfjeld-Johnsen J.Otol Neurotol. 2017 Oct;38(9):1355-1361.