MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN), a biotech company specializing in the treatment of inner ear diseases, today announced that initial clinical results of the phase 1b study on the SENS-111 drug candidate have been presented during a poster session at the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting & OTO EXPO, held in San Diego, California from September 18 – 21, 2016.
Poster: SENS-111, H4 Antagonist for Treatment of Peripheral Vertigo, Is Safe
The aim of this double blind randomized placebo controlled study was to evaluate the overall safety and determine the pharmacokinetic profile of SENS-111 in 100 healthy volunteers. The study consisted of assessing Treatment Emergent Adverse Events (TEAE) and was divided into two parts:
- Part 1: Single oral dose of either a placebo or SENS-111 at doses ranging from 100 to 500 mg in 5 cohorts of 8 healthy volunteers (2 receiving a placebo, 6 receiving SENS-111);
- Part 2: Once-daily oral doses of a placebo or SENS-111 over 4 or 7 consecutive days at doses ranging from 50 to 250 mg in 5 cohorts of 12 healthy volunteers (3 receiving a placebo, 9 receiving SENS-111).
The TEAE rate was lower in the SENS-111 group (16%, versus 36% in the placebo group) and no serious or severe adverse effects were reported, even at higher doses, demonstrating an excellent clinical safety profile.
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 analysis of the safety data collected via this study has enabled us to conclude that SENS-111 is a well-tolerated product with an acceptable pharmacokinetic profile. This data is all the more pertinent given that it was obtained via a fairly broad population for a phase 1 study.”
Pierre Attali, Sensorion’s Chief Medical Officer, adds: “We are delighted that our drug candidate for acute vertigo has been demonstrated to be well-tolerated and easy to take. It is now ready to be assessed in patients who are suffering from this debilitating pathology in an upcoming international phase 2 study.”
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.