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Frequency Therapeutics Begins Recruiting for Phase 2 Study of FX-322 in Patients with Sensorineural Hearing Loss

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

Signs of Improved Hearing With Progenitor Cell Activator (FX-322)

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

WSJ: Cures for Hearing Loss May Be Found in New Drugs

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

Researchers find proteins that might restore damaged sound-detecting cells in the ear

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.

Research Spotlight: Avenanthramide-C (AVN-C) prevents noise- and drug-induced hearing loss while protecting auditory hair cells from oxidative stress

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 24โ€‰h 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€‰+โ€‰F). 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€‰+โ€‰F 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]

Sound Pharmaceuticals announces positive topline results from SPI-1005 Phase 2b clinical trial… clinically relevant improvements in sensorineural hearing loss… 65% and 95% over placebo at 8 weeks…

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

Triamcinolone a Safe and Efficacious Treatment Option for Idiopathic Sudden Sensorineural Hearing Loss, Study Says

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]

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