https://www.bostonglobe.com/2020/02/02/metro/boston-area-startups-making-slow-progress-fight-against-hearing-loss/
Boston area startups making slow progress in fight against hearing loss
www.HearingLossTreatmentReport.com
https://www.bostonglobe.com/2020/02/02/metro/boston-area-startups-making-slow-progress-fight-against-hearing-loss/
Boston area startups making slow progress in fight against hearing loss
http://www.pharmatimes.com/news/new_fast-track_system_for_tinnitus_and_hearing_loss_1321998
New ‘fast-track’ system for tinnitus and hearing loss
Action on Hearing Loss and the Medicines Discovery Catapult have teamed up to launch a new “Hearing Medicines Discovery Syndicate”, a collaboration designed to accelerate the “much-needed development” of treatments for hearing loss and tinnitus.
The collaboration will be partnering with the National Institute for Health Research (NIHR), with academic expertise in hearing research provided University College London Hospitals BRC, Nottingham BRC and Manchester BRC, and the Cell and Gene Therapy Catapult.
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/20191218005137/en/Pipeline-Therapeutics-Completes-30-Million-Series-Financing
Pipeline Therapeutics’ lead candidate, PIPE-505, is entering Phase 1b/2a testing to treat mild-to-moderate sensorineural hearing loss (SNHL) associated with cochlear synaptopathy. PIPE-505 is uniquely positioned to treat this patient population as it can have an impact on both audibility and speech intelligibility, addressing two separate pathologies associated with hearing loss.
Pipeline Therapeutics Completes $30 Million Series B Financing – Proceeds to advance PIPE-505 in hearing loss
https://medicalxpress.com/news/2019-12-reprogramming-ear-regrow-hair-cells.html
DECEMBER 4, 2019
Reprogramming inner ear to regrow hair cells promising target for hearing loss treatments
by Massachusetts Eye and Ear Infirmary
https://www.cuimc.columbia.edu/news/3d-printed-microneedles-open-ears-new-treatments
3D-Printed Microneedles Open Ears to New Treatments
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.news-medical.net/news/20191106/New-therapy-has-potential-to-repair-cells-damaged-by-noise-prevent-hearing-loss.aspx
New therapy has potential to repair cells damaged by noise, prevent hearing loss
Targeting the Inner Ear
New startups are taking aim at delivering drugs to help treat hearing loss
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
The phase 2a study of FX-322 in Adults With Stable Sensorineural Hearing Loss is now recruiting at 12 locations in 8 different states.
Previously, the only clinical trial location listed on the study page was in North Carolina. Not anymore…
Here is the expanded list featuring 11 new locations in 7 other states:
This information was found on the official FX-322 phase 2a study record page, which was recently updated to include these new study locations on Thursday, October 17, 2019.
Could even more locations be added to this phase 2a study?
It’s possible.
However, based on the study’s estimated enrollment — limited to 96 participants — it seems unnecessary.
And what about FX-322 trials outside of the United States? Nothing to report yet. (That will be the topic of a separate post.)
As of Saturday, October 19, 2019, all 12 of the study locations listed above are now recruiting participants.
https://www.biospace.com/article/releases/frequency-therapeutics-commences-dosing-in-its-phase-2a-study-of-fx-322-for-sensorineural-hearing-loss-fda-grants-fx-322-fast-track-designation/
Frequency Therapeutics Commences Dosing in its Phase 2a Study of FX-322 for Sensorineural Hearing Loss; FDA Grants FX-322 Fast Track Designation
Frequency Therapeutics is now recruiting patients for phase 2 of its clinical trial of FX-322 in patients with sensorineural hearing loss.
This phase 2a study will assess the exploratory efficacy, as well as the local and systemic safety of single and repeat intratympanic doses of FX-322 compared to placebo in approximately 96 subjects with stable mild to moderately severe sensorineural hearing loss, with a medical history consistent with either excessive noise exposure or idiopathic sudden sensorineural hearing loss.
The study was added and updated to ClinicalTrials.gov on October 9, 2019.
There IS a placebo group… and…
Estimated enrollment is 96 participants and the first recruiting location is North Carolina.
The study is titled FX-322 in Adults With Stable Sensorineural Hearing Loss and can be found on ClinicalTrials.gov at this link: https://clinicaltrials.gov/ct2/show/NCT04120116?type=Intr&cond=Hearing+Loss&lupd_s=09%2F25%2F2019&lupd_d=14&sort=nwst
https://finance.yahoo.com/news/agtc-otonomy-announce-strategic-collaboration-113000562.html
AGTC and Otonomy Announce Strategic Collaboration to Develop and Commercialize Gene Therapy for Congenital Hearing Loss
https://www.sciencedaily.com/releases/2019/09/190926073350.htm
https://www.medpagetoday.com/meetingcoverage/aaohnsf/82242
Signs of Improved Hearing With Progenitor Cell Activator
Some pure tone improvement, significant increases in word recognition
https://journals.sagepub.com/doi/full/10.1177/0194599819858141f
http://investors.otonomy.com/news-releases/news-release-details/otonomy-initiating-phase-12-clinical-trial-oto-413-hearing-loss
Otonomy Initiating Phase 1/2 Clinical Trial of OTO-413 in Hearing Loss
Results expected in second half of 2020
https://www.wsj.com/articles/cures-for-hearing-loss-may-be-found-in-new-drugs-11568599440
Cures for Hearing Loss May Be Found in New Drugs
Researchers are trying to counter the biological causes of hearing loss—rather than just treating the effects
https://www.businesswire.com/news/home/20190913005035/en/Akouos-Launches-Sing-Registry-Inform-Future-Therapeutic
Akouos Launches The Sing Registry to Inform Future Therapeutic Development for Genetic Sensorineural Hearing Loss
https://www.businesswire.com/news/home/20190912005094/en/Akouos-Discloses-Lead-Program-AK-OTOF-Potential-Gene
Akouos Discloses Lead Program, AK-OTOF, a Potential Gene Therapy for Sensorineural Hearing Loss
https://finance.yahoo.com/news/strekin-ag-announces-completion-patient-061500086.html
https://www.strekin.com/images/Press/20190911-Strekin-PR-recruitment-E.pdf
Strekin AG Announces Completion of Patient Recruitment in the RESTORE Phase 3 Clinical Study of STR001
https://xconomy.com/boston/2019/09/06/frequency-plans-ipo-for-hearing-loss-drug-more-regenerative-meds/
Frequency Plans IPO for Hearing Loss Drug & More Regenerative Meds
https://www.wdrb.com/news/national/strekin-ag-secures-financing-to-complete-development-of-str-in/article_e72a63e6-c808-57a8-9463-c5aea14c766e.html
Strekin AG Secures Financing to Complete Development of STR001 in Sudden Sensorineural Hearing Loss and to Prepare NDA Filing in Europe
https://www.sciencedaily.com/releases/2019/08/190805101127.htm
Researchers find proteins that might restore damaged sound-detecting cells in the ear
Date:
August 5, 2019
Source:
Johns Hopkins Medicine
Summary:
Using genetic tools in mice, researchers say they have identified a pair of proteins that precisely control when sound-detecting cells, known as hair cells, are born in the mammalian inner ear. The proteins may hold a key to future therapies to restore hearing in people with irreversible deafness.
https://www.frequencytx.com/news-events/news-events-press-release-07-23-2019.php
Investor dollars flow to Frequency Therapeutics as company prepares to advance lead clinical candidate, FX-322, into Phase 2a study of sensorineural hearing loss, a condition for which there are no approved therapies…
https://www.nature.com/articles/s41420-019-0195-1
https://www.ncbi.nlm.nih.gov/pubmed/31312524?dopt=Abstract
Avenanthramide-C prevents noise- and drug-induced hearing loss while protecting auditory hair cells from oxidative stress.
Cell Death Discov. 2019;5:115
Authors: Umugire A, Lee S, Kim D, Choi M, Kim HS, Cho HH
Abstract
Noise exposure or ototoxic drugs instigate various types of damage to the cochlea, resulting in hearing loss (HL). While the incidence of HL is growing continuously, there are, so far, no adequate drugs to prevent or treat HL. Avenanthramide (AVN), a natural product extracted from oats, has been reported to possess anti-oxidant/inflammatory properties, and protect several types of cells. In this study, we investigated whether AVN-C can protect auditory hair cells, and preserve hearing from noise trauma and ototoxic drugs. Wild-type C57BL/6 mice were used to generate several HL models. Serum and perilymphatic fluid samples were analyzed using mass spectrophotometry to detect AVN-C. AVN-C crossed the blood-labyrinth barrier, and was detected in the perilymph after systemic injection. Pretreatment by AVN-C 24โh before exposure to temporary threshold shift noise contributed to the preserving hearing. Moreover, in the case of permanent threshold shift, AVN-C provided significant protection from noise. AVN-C also strongly protected against deterioration in hearing due to kanamycin and furosemide (Kโ+โF). According to the results of our scanning electron microscopy analysis, many outer hair cells (OHCs) were destroyed by noise trauma, while AVN-C prevented these losses. OHC loss due to Kโ+โF was even more severe, even affecting the apex. Strikingly, AVN-C treatment maintained OHCs at a level comparable to normal cochlea. AVN-C reduced the dichlorofluorescin (DCF)-positive population in gentamicin-treated HEI-OC1 in vitro. The expressions of TNF-a, BAK, IL-1b, and Bcl-2 were attenuated by AVN-C, revealing its antioxidant effects. The results of this study show that AVN-C crosses the blood-labyrinth barrier and provide a significant protection against noise- and drug-induced ototoxicity. Hence, AVN-C is a good candidate for future therapy aimed at protecting against sensorineural HL.
PMID: 31312524 [PubMed]
https://www.fiercebiotech.com/biotech/astellas-picks-up-frequency-s-regenerative-hearing-loss-med-outside-u-s-for-80m
https://scrip.pharmaintelligence.informa.com/SC125552/Astellas-Adds-To-Regenerative-Medicine-Portfolio-In-Hearing-Loss-Deal-With-Frequency
Astellas Adds To Regenerative Medicine Portfolio In Hearing Loss Deal With Frequency
https://finance.yahoo.com/news/sensorion-receives-fda-ind-approval-053000700.html
Sensorion Receives FDA IND Approval for Arazasetron (SENS-401)
https://interestingengineering.com/research-highlights-different-types-of-hearing-loss-and-need-for-new-unique-treatments
Research Highlights Different Types of Hearing Loss And Need for New Unique Treatments
New research shows that different types of hearing loss are best treated by specially tailored solutions.
https://journals.lww.com/thehearingjournal/Fulltext/2019/07000/Inner_Ear_Drug_Delivery__Tomorrow_s_Treatment_for.1.aspx
Inner Ear Drug Delivery
Tomorrow’s Treatment for Hearing Loss?
Optimized gene-editing system halts hearing loss in mice with hereditary deafness
https://www.thelondoneconomic.com/lifestyle/health/radical-cure-for-deafness-may-have-been-found-thanks-to-lab-animals/03/07/
Radical cure for deafness may have been found thanks to lab animals
Scientists revealed that hearing has been salvaged in mice by ‘snipping’ a mutation out of their DNA.
https://finance.yahoo.com/news/sound-pharmaceuticals-announces-positive-topline-130000754.html
Sound Pharmaceuticals announces positive topline results from SPI-1005 Phase 2b clinical trial… clinically relevant improvements in sensorineural hearing loss… 65% over placebo at 8 weeks
http://www.koreabiomed.com/news/articleView.html?idxno=5927
Daewoong to develop hearing loss treatment using ion-channel platform tech
https://www.ncbi.nlm.nih.gov/pubmed/31192900?dopt=Abstract
https://journals.lww.com/otology-neurotology/Abstract/2019/07000/Intratympanic_Triamcinolone_Acetonide_as_Treatment.4.aspx
Intratympanic Triamcinolone Acetonide as Treatment Option for Idiopathic Sudden Sensorineural Hearing Loss.
Otol Neurotol. 2019 Jul;40(6):720-727
Authors: Dahm V, Nieratschker M, Riss D, Kaider A, Auinger A, Honeder C, Arnoldner C
Abstract
INTRODUCTION: Corticosteroids represent the most commonly used treatment option for patients with idiopathic sudden sensorineural hearing loss. In the past, these compounds were mainly formulated and tested for intravenous or oral administration. Intratympanic application is increasingly being used, often as salvage treatment. The most suitable corticosteroid for local application has yet to be identified. Trials have suggested that triamcinolone acetonide has superior molecular properties for this treatment modality.
METHODS: The main aim of this study was to retrospectively assess the first audiometric results of patients diagnosed with idiopathic sudden sensorineural hearing loss and treated simultaneously with systemic prednisolone and intratympanic triamcinolone acetonide. This data was then compared to systemic treatment only, as well as to historic cohorts treated intratympanically with widely used corticosteroids, namely dexamethasone or methylprednisolone.
RESULTS: 90 patients received intravenous prednisolone only, and 89 individuals underwent intravenous treatment combined with three to four simultaneous intratympanic applications of triamcinolone. Eight patients received intratympanic triamcinolone as first-line treatment. After adjusting data for sex, time since onset, age, and severity of hearing loss, no statistically significant difference between the two main treatment groups could be identified. No major adverse events were observed, specifically no otitis media or persistent vertigo. Two perforated tympanic membranes healed spontaneously within several days.
CONCLUSION: While the exact role of intratympanic injections requires additional trials, triamcinolone resulted in similar outcomes compared to studies using dexamethasone or methylprednisolone. Due to favorable pharmacological properties, triamcinolone represents a safe and efficacious alternative for intratympanic treatment in idiopathic sensorineural hearing loss.
PMID: 31192900 [PubMed – in process]
https://www.sciencedaily.com/releases/2019/06/190611133953.htm
Drug to treat malaria could mitigate hereditary hearing loss
https://www.apnews.com/Business%20Wire/d2f0d4c0a9864ab795c75f837f1792b0
https://finance.yahoo.com/news/rinri-therapeutics-secures-1-4-060000946.html
https://clinicaltrials.gov/ct2/show/NCT02132130?type=Intr
https://www.drugdevelopment-technology.com/news/frequency-fx-322-hearing-restoration-data/
https://www.fiercebiotech.com/biotech/frequency-shows-early-positive-results-for-small-molecule-hearing-loss-therapy
https://www.standard.co.uk/news/health/drug-being-tested-in-london-could-be-breakthrough-in-treating-hearing-loss-a4083811.html
https://www.wcvb.com/article/local-company-working-on-treatment-to-reverse-hearing-loss/26596728
https://futurism.com/the-byte/gene-therapy-deafness-mice
SCIENTISTS USED GENE THERAPY TO CURE DEAFNESS IN MICE
https://www.b3cnewswire.com/201902051883/audion-therapeutics-and-regain-consortium-announce-positive-phase-i-results-in-patients-with-sensorineural-hearing-loss.html
https://www.biospace.com/article/releases/audiocure-pharma-s-ac102-receives-ema-orphan-drug-designation-for-the-treatment-of-sudden-sensorineural-hearing-loss-ssnhl-/
https://www.abc.net.au/news/2018-11-08/nanoparticle-treatment-possible-for-common-form-of-hearing-loss/10477498
http://investors.otonomy.com/news-releases/news-release-details/otonomy-presents-data-highlighting-potential-oto-413-otic
https://medicalxpress.com/news/2018-10-therapy-loss.html
https://www.fiercebiotech.com/research/cochlear-neuron-discovery-could-mean-new-treatments-for-hearing-loss
Cochlear neuron discovery could yield new treatments for hearing loss
https://www.sciencedirect.com/science/article/abs/pii/S1359644617303173?via%3Dihub
https://pubmed.ncbi.nlm.nih.gov/29733894/
Cochlear hair cell regeneration: an emerging opportunity to cure noise-induced sensorineural hearing loss
Author links open overlay panelIbrahimaYoumWeiLi
https://doi.org/10.1016/j.drudis.2018.05.001