www.HearingLossTreatmentReport.com
https://www.businesswire.com/news/home/20210218006082/en/Sensorion-Presents-New-Preclinical-Data-on-SENS-401-at-ARO-2021
Sensorion Presents New Preclinical Data on SENS-401 at ARO 2021
SENS-401 yields significant treatment benefits in rats with severe hearing loss when initiated with a delay up to 7 days after the initial acoustic trauma
Sensorion presenting three posters at Association for Research in Otolaryngology (ARO) meeting
ARO will be hosted virtually on February 20-24, 2021
https://www.businesswire.com/news/home/20210104005852/en/Sensorion-Provides-an-Update-on-Plans-and-Progress-in-the-Development-of-SENS-401-for-the-Prevention-of-Hearing-Loss
Sensorion Provides an Update on Plans and Progress in the Development of SENS-401 for the Prevention of Hearing Loss
Clinical trial to treat patients suffering from Cisplatin Induced Ototoxicity (CIO) with SENS-401 expected to start in H2 2021
Natural history study in CIO expected to start in H1 2021 to generate data on disease evolution
Phase 2 topline results from SENS-401 study in SSNHL delayed further due to COVID-19 and now expected in Q4 2021
https://www.businesswire.com/news/home/20201214005892/en/Sonova-Invests-%E2%82%AC5-Million-in-Sensorion-as-the-Companies-Plan-a-Collaboration-in-Hearing-Loss
Sonova Invests €5 Million in Sensorion as the Companies Plan a Collaboration in Hearing Loss
Sonova invests at €1.70 per share, to hold circa 3.7% stake in Sensorion
Companies signed a letter of intent relating to a collaboration to develop new solutions for hearing loss
https://clinicaltrials.gov/ct2/show/NCT03603314?type=Intr&cond=Hearing+Loss&lupd_s=05%2F05%2F2020&lupd_d=14&sort=nwst
Condition : Severe Sudden Sensorineural Hearing Loss
Interventions : Drug: SENS-401; Other: Placebo Oral Tablet
Sponsor : Sensorion
Recruiting
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
NCT03603314
Fri, 27 Jul 2018 12:00:00 EDT
Last Update Posted: 05/19/20 06:40AM
https://www.businesswire.com/news/home/20201020006234/en/Sensorion-reports-2020-first-half-results
Preclinical data from these studies are expected by the end of 2020.
Sensorion reports 2020 first half results
Financial position strengthened with €31m (US$36.5m) capital raise in September 2020
Gene therapy agreement expands pipeline and preclinical data
SENS-401 Phase II trial progressing with results expected in mid-2021
Cash position of €30.7m as of June 30, 2020, further reinforced by September capital raise
Cash runway now extended to H2 2022
https://finance.yahoo.com/news/sensorion-provides-sens-401-ssnhl-063000237.html
Sensorion provides update on SENS-401 SSNHL Phase 2 AUDIBLE-S trial enrollment
https://www.businesswire.com/news/home/20191222005022/en/
https://www.biospace.com/article/releases/sensorion-announces-5-6m-non-dilutive-funding-to-support-sens-401-phase-2-study-in-sudden-sensorineural-hearing-loss-french-ministry-of-armed-forces-to-participate-in-the-study/
Sensorion Announces €5.6m Non-Dilutive Funding to Support SENS-401 Phase 2 Study in Sudden Sensorineural Hearing Loss; French Ministry of Armed Forces to Participate in the Study
https://www.businesswire.com/news/home/20191106005839/en/Sensorion-Announces-Oral-Presentation-New-SENS-401-Preclinical/
Sensorion Announces an Oral Presentation of New SENS-401 Preclinical Data at ISIET 2019 in Hannover: An oral presentation on the capacity of SENS-401 to reduce central auditory neuron loss after acoustic trauma in preclinical studies
SENS-401 shows capacity to reduce central auditory neuron loss after acoustic trauma in preclinical studies
https://www.businesswire.com/news/home/20191022006061/en/Sensorion-Announces-Poster-Presentation-New-SENS-401-Preclinical
Sensorion Announces a Poster Presentation of New SENS-401 Preclinical Data at SFN 2019 in Chicago
A poster presentation on the absence of impact due to acoustic trauma on the SENS-401 inner ear exposure in preclinical studies
Sensorion Announces a Poster Presentation of New SENS-401 Preclinical Data at SFN 2019 in Chicago
A poster presentation on the absence of impact due to acoustic trauma on the SENS-401 inner ear exposure in preclinical studies
https://journals.lww.com/otology-neurotology/Abstract/2019/02000/SENS_401_Effectively_Reduces_Severe_Acoustic.29.aspx
https://www.ncbi.nlm.nih.gov/pubmed/30570608
SENS-401 Effectively Reduces Severe Acoustic Trauma-Induced Hearing Loss in Male Rats With Twice Daily Administration Delayed up to 96 hours
Abstract
HYPOTHESIS:
SENS-401 (R-azasetron besylate) is effective against severe acoustic trauma-induced hearing loss.
BACKGROUND:
SENS-401 has calcineurin inhibiting properties and attenuates cisplatin-induced hearing loss in a rat model. Cisplatin-induced and acoustic trauma-induced hearing loss share common apoptotic pathways.
METHODS:
The dose-response relationship of SENS-401 (6.6 mg/kg BID, 13.2 mg/kg BID, 26.4 mg/kg QD) and treatment time-window (13.2 mg/kg BID starting 24, 72, and 96 h posttrauma) versus placebo for 28 days were evaluated in a male rat model of severe acoustic trauma-induced hearing loss (120 dB SPL, 2 h) using auditory brainstem response (ABR) and distortion product otoacoustic emissions (DPOAE) measures followed by cochlear outer hair cell (OHC) counting with myosin-VIIa immunolabeling.
RESULTS:
All SENS-401 doses improved ABR threshold shift and recovery, reaching statistical significance (p < 0.05) for ABR threshold recoveries after 28-days treatment. DPOAE amplitude loss and recovery improved markedly for 13.2 mg/kg BID SENS-401, reaching significance after 14 days (p < 0.05). Significant improvements in ABR threshold shifts/recovery and DPOAE amplitude loss occurred with up to 96-hours delay in initiating SENS-401 (p < 0.05), and in DPOAE amplitude recovery with up to 72-hours delay (p < 0.05). Significantly more surviving OHCs were present after SENS-401 treatment compared with placebo after 24 to 96-hours delay posttrauma, with up to 5.3-fold more cells in the basal cochlea turn.
CONCLUSIONS:
In vivo data support the otoprotective potential of twice daily oral SENS-401. Improvements in hearing loss recovery make SENS-401 a promising clinical candidate for acoustic trauma-induced hearing loss, including when treatment is not initiated immediately.
