Safety and pharmacokinetic profile of the MEANING-401 confirmed
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Montpellier, June 8, 2017 Sensorion (FR0012596468 ALSEN / Eligible PEA-PME), a biotechnology company specializing in the treatment of inner-ear diseases, today announces positive results from phase 1 clinical trial of its drug candidate MEANING-401 for the treatment, by the oral, lesions of the inner ear.
The SENSE-401 is a small molecule whose ability of anti-injury to the indications for cochlear have been identified by the screening platform of Sensorion and verified in preclinical models.
The phase 1 study was conducted in Britain in 36 healthy volunteers with the aim of assessing the tolerance of different doses of the SENSE-401 versus placebo, and to define its pharmacokinetic profile, allowing the choice of the doses to use in phase 2. The SENSE-401 was administered orally at doses of 29 mg and 43.5 mg, one to two times per day for 7 days. The study has demonstrated a very good clinical tolerance of the SENSE-401.
The plasma concentrations obtained correspond to those observed in the animal models that have demonstrated the activity of the SENSE-401 in the hearing loss severe induced by trauma acoustique1 or by a cancer, the cisplatine2, a chemotherapy widely used in humans.
These results reinforce the clinical progress of the company and confirm the ability of the technology platform Sensorion to identify good candidates for clinical phases and anticipating on the proper dosage to administer in humans.
Pierre Attali, Chief medical officer of Sensorion, commented : “This study validates the safety and pharmacokinetic profile of the MEANING-401, and supports our desire to continue the clinical development of this compound in the treatment of lesions of the inner ear. ”
Nawal Ouzren, Director-general of Sensorion, concludes : “The data obtained can support our efforts with the regulatory authorities in order to define the optimal strategy for the clinical development of phase 2 of the SENSE-401 in the severe hearing loss. This condition is very disabling, induced by various factors such as acoustic shock, or certain drugs, is marked by major therapeutic needs unmet. ”
1 See press release dated November 17, 2016 on the preclinical data of the SENSE-401 in the hearing loss acute sensorineural, presented at the congress of Neuroscience 2016
2 See press release dated may 2, 2017 on the preclinical data of the SENSE-401 in the hearing loss induced by cisplatin, presented at the congress COSM 2017
About the MEANING-401
The SENSE-401, R-azasetron besylate is a drug candidate designed to protect and preserve the tissues of the inner ear in the case of damage arising that may lead to hearing problems, evolutionary or following. This is one of the two enantiomeric forms of the azasetron, a molecule racemic of the family of setrons marketed in Asia under the name of Serotone. The enantiomers are products having an identical chemical structure but a configuration in the space is different, in the mirror, as for example a right hand and a left hand. Tests of pharmacological and pharmacokinetic carried out showed a profile of drug candidate superior to the SENSE-401 compared to the other enantiomer and the racemic form. MEANING-401 is a small molecule that can be administered by oral or injectable, and has obtained in Europe, Orphan Drug Designation in the hearing loss acute sensorineural.
About Sensorion :
Sensorion is a biotechnology company specializing in the treatment of the pathologies of the inner ear such as severe dizziness, tinnitus or hearing loss. Two products are in clinical development, the MEANING-111 in phase 2 in the vestibular neuritis acute, and the SENSE-401 has completed a phase 1 study. Based within the Inserm, the Company has strong experience in pharmaceutical R&D and a technological platform to complete to develop medicines for first-in-class easily administrable, in particular oral, for the treatment and prevention of hearing loss and the symptoms of attacks of vertigo and tinnitus. Based in Montpellier, Sensorion has received financial support from Bpifrance, through the funds InnoBio and Inserm Transfert Initiative.
Sensorion is listed on Alternext Paris since the month of April 2015. www.sensorion-pharma.com. www.sensorion-pharma.com.
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