MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (FR0012596468 – ALSEN) (Paris:ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announces that the results of the caloric test undertaken during the phase 1b clinical trial on SENS-111 have been presented at the EACPT (European Association for Clinical Pharmacology and Therapeutics) conference held in Opatija, Croatia, from October 6 to 9, 2016.
The caloric test, developed by Robert Barany Nobel Prize laureate in Medicine in 1914, is a diagnostic test used in clinical practice to explore the balance (vestibular) system in patients suffering from vertigo. Cold and hot water are in turn instilled into both ears via a nozzle; this test determines whether the vestibular system is functioning correctly.
Within the phase 1b clinical trial with SENS-111, Sensorion used this test in 60 healthy volunteers, modifying it to induce the symptoms of vertigo and thus to assess the activity of SENS-111 administered via daily oral doses increasing from 50mg to 250mg over 4 to 7 days.
The resulting data analysis proved that SENS-111 slowed the appearance of vertigo in a statistically significant manner at plasma concentrations of up to 500ng/mL. Above this concentration level, this positive effect progressively disappeared. In a consistent way, the duration of the vertigo was gradually and significantly reduced up to these same levels of SENS-111 plasma concentration.
Prof. Frédéric Venail M.D. Ph.D., ENT department of the Gui de Chauliac University Hospital in Montpellier, INSERM U1051 Physiopathology of Sensory and Motor Deficits unit, stated: “The results of the caloric test show that SENS-111 has an effect in reducing bouts of vertigo induced in healthy volunteers. These results are of crucial importance for clinicians and patients, given the debilitating nature of crises of vertigo and the limited efficacy of the treatments that are currently available. We are eager to assess SENS-111’s efficacy profile on a broader scale within a phase 2 clinical trial.”
Pierre Attali, Sensorion’s Chief Medical Officer, adds: “The results obtained with SENS-111 in the caloric test are entirely consistent with those obtained in preclinical tests in our screening platform. They confirm the latter’s ability to identify first-in-class orally active molecules, validating one of the major differentiating factors of our technology. These results have enabled us to define the optimal dose of SENS-111 for the international phase 2 study in patients with acute severe vertigo that is currently being prepared.”
SENS-111 is the first representative of the histamine type 4 receptor antagonist class tested in inner-ear pathologies. This drug candidate displays a neuromodulation effect of the sensorineural inner ear cell function and is being developed for the symptomatic treatment of vertigo crises or tinnitus. SENS-111 is a small molecule that can be taken orally or via a standard injection, and has been successfully assessed in humans in phase 1b.
Sensorion specializes in the treatment of pathologies of the inner ear such as acute vertigo, tinnitus and hearing loss. The company was founded by Inserm (the French Institute of Health and Medical Research) and is utilizing its pharmaceutical R&D experience and comprehensive technology platform to develop first-in-class easy-to-administer, notably orally active, drug candidate programs for treating hearing loss and the symptoms of vertigo and tinnitus, for preventing and treating complications associated with progressive lesions in the inner ear, and for preventing the toxicity of chemotherapy in the inner ear. Based in Montpellier, southern France, Sensorion received financial support from Bpifrance, through the InnoBio fund, and Inserm Transfert Initiative.
Sensorion is listed on Alternext Paris since April 2015. www.sensorion-pharma.com
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 référence registration document filed with the Autorité des marchés financiers (AMF- French Financial Market Authority) on July 28, 2016 under n°R.16-069 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.
ISIN code: FR0012596468