Sensorion receives approval to initiate POC clinical trial of SENS-401
Category: #health  By Pankaj Singh  Date: 2022-06-08
 | 
  • sharesocial_share_icon
  • Twitter
  • Facebook
  • LinkedIn

Sensorion receives approval to initiate POC clinical trial of SENS-401

Leading clinical-stage biotech company Sensorion has reportedly received approval from the French regulatory authorities to initiate a POC (Proof of Concept) clinical trial of Arazasetron (SENS-401).

A Phase 2a trial with SENS-401 will be conducted on patients scheduled for cochlear implantation owing to profound or moderately severe hearing impairment.

The randomized, multicenter, open-label and controlled trial will assess the presence of SENS-401 in the perilymph (cochlea) a week after administering two doses every day to adult participants before cochlear implantation. Patients will be provided with SENS-401 for 49 days.

Furthermore, the trial will evaluate measures of secondary outcome. This includes the changes in the hearing threshold of the implanted ear at different frequencies from baseline to the end of the study tenor. The first patient is expected to be enrolled by mid-2022.

Preservation of natural hearing is essential for speech recognition. At the beginning of last year, Sensorion revealed positive preclinical results exhibiting that a cochlear implant- SENS-401 molecule combination helped in reducing residual hearing loss at a frequency beyond the electrode array.

Preclinical studies were conducted in collaboration with Cochlear Ltd., a global leader in implantable hearing.

Sensorion CMO Géraldine Honnet noted that the company is seeing positive preclinical data that backs its innovative methods of consolidating cochlear implants and SENS-401. Honnet believes that it can produce substantial clinical benefits for patients diagnosed with hearing loss.

For the uninitiated, SENS-401 is a drug candidate that intends to safeguard and preserve inner ear tissue from damage leading to sequelar or progressive hearing impairment. It is a small molecule that can be administered orally or through an injection.

SENS-401 has acquired Orphan Drug Designation in Europe for treating sudden sensorineural hearing loss. It also received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for preventing platinum-induced ototoxicity in children.

Source credit:

https://www.businesswire.com/news/home/20220606005846/en/Sensorion-Announces-Approval-in-France-to-Initiate-Proof-of-Concept-Clinical-Trial-of-SENS-401-for-Residual-Hearing-Preservation-During-Cochlear-Implantation



About Author

Pankaj Singh

Email: [email protected]   linkdin twitter

Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

More News By Pankaj Singh

Rona Therapeutics obtains global rights to Sanofi's siRNA platform

Rona Therapeutics obtains global rights to Sanofi's siRNA platform

By Pankaj Singh

Rona Therapeutics Inc has reportedly acquired the global exclusive rights to the siRNA platform of delivery moiety and chemical modification from Sanofi S.A., in addition to four pre-clinical contenders for unrevealed ...

Toy maker Mattel inks multi-year agreement with Elon Musk’s SpaceX

Toy maker Mattel inks multi-year agreement with Elon Musk’s SpaceX

By Pankaj Singh

California-based toy manufacturing and entertainment company, Mattel, has recently signed a multi-year agreement with Elon Musk’s private spaceflight company, SpaceX.

T...

USHV partners with Willowbrook to provide quality cardiovascular care

USHV partners with Willowbrook to provide quality cardiovascular care

By Pankaj Singh

US Heart & Vascular (USHV) is reportedly partnering with Willowbrook Cardiovascular Associates to offer quality cardiovascular care in the Houston market.

USHV has a strong ma...