New York, USA, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Hearing Loss Clinical Trial Pipeline Insights Featuring 35+ Companies | DelveInsight
DelveInsight’s hearing loss pipeline report depicts a robust space with 35+ active players working to develop 45+ pipeline therapies for hearing loss treatment.
DelveInsight’s 'Hearing Loss Pipeline Insight 2022' report provides comprehensive global coverage of available, marketed, and pipeline hearing loss therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the hearing loss pipeline domain.
Key Takeaways from the Hearing Loss Pipeline Report
- DelveInsight’s hearing loss pipeline report depicts a robust space with 35+ active players working to develop 45+ pipeline therapies for hearing loss treatment.
- Key hearing loss companies such as Sensorion, Pipeline Therapeutics, Frequency Therapeutics, Otonomy, Inc., Strekin AG, Heyu (Suzhou) Pharmaceutical Technology Co., Ltd, Sound Pharmaceuticals Incorporated, Novartis, Gateway Biotechnology, Inc., Decibel Therapeutics, Akouos, Acousia Therapeutics GmbH, AGTC, BridgeBio Inc., Lineage Cell Therapeutics, Inc., Rinri Therapeutics Ltd., Autifony Therapeutics, AudioCure Pharma GmbH, Anida Pharma Inc., Mogrify, Astellas Pharma Inc., Altamira Therapeutics, Myrtelle, Hoba Therapeutics, Perha Pharmaceuticals, and others are evaluating new hearing loss drugs to improve the treatment landscape.
- Promising hearing loss pipeline therapies such as PIPE 505, FX-322, SENS-401, OTO-413, STR001, HY01, SPI-1005, CGF166, Zonisamide, DB-OTO, AAV.103, AAV.104, DB-020, AK-OTOF, ACOU085, ACOU082, OTO-825, OTO-6XX, OTO-510, ,BBP-815, FX-345, Auditory Neuronal Cell Therapy, AC102, AP-001, AM-111, HB-097, and others are under different phases of hearing loss clinical trials.
- In September 2022, Sensorion announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) had adopted a positive opinion on Sensorion’s application for Orphan Drug Designation (ODD) for its lead therapy gene candidate, OTOF-GT, a gene therapy intended for the treatment of otoferlin gene mediated hearing loss.
- In September 2022, Decibel Therapeutics announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial in pediatric patients of DB-OTO, a gene therapy product candidate designed to provide durable restoration of hearing in individuals with profound congenital hearing loss due to an otoferlin deficiency.
- In September 2022, Akouos, Inc. announced that it had received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1/2, first in human, pediatric clinical trial of AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss.
- In July 2022, Mogrify Limited and Astellas Pharma Inc. announced that they had executed a collaborative research agreement on in vivo regenerative medicine approaches to address sensorineural hearing loss.
- In May 2022, Acousia Therapeutics GmbH announced that it would present data on the company’s clinical stage, first-in-class lead candidate ACOU085 at the Hanson Wade 2nd Inner Ear Therapeutics Summit to be held in person in Boston (MA) from June 20–23, 2022.ACOU085 is a proprietary, first-in-class, small-molecule otoprotective drug candidate, which is currently being tested in a Phase 1b clinical trial involving age-related hearing loss (ARHL) patients.
- In April 2022, Otonomy, Inc. announced positive top-line results from the Phase 2a clinical trial of OTO-413 in subjects with hearing loss. The randomized, double-blind, placebo-controlled trial demonstrated that a single intratympanic injection of 0.3 mg OTO-413, a sustained exposure formulation of brain-derived neurotrophic factor (BDNF), provided clinically meaningful treatment benefit versus placebo across multiple speech-in-noise (SIN) hearing tests as well as the Patient Global Impression of Change (PGIC) at consecutive time points (Days 57 and 85).
- In March 2022, Lineage Cell Therapeutics, Inc. announced that the Company is expanding its novel cell therapy pipeline to include a new investigational product candidate, an auditory neuronal cell transplant for the treatment of hearing loss, with an initial focus on the treatment of auditory neuropathy spectrum disorders.
Request a sample and discover the recent advances in hearing loss treatment drugs @Hearing Loss Pipeline Report
The hearing loss pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage hearing loss drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the hearing loss clinical trial landscape.
Hearing Loss Overview
Hearing loss is a very common medical condition that increases in frequency and severity with age. The affected population is also large, ranging from newborns to elderly patients, and is nearly universal in the 70+ age group. Sound waves arriving at the auricle, passing through the external auditory canal (EAC), and causing a vibration of the tympanic membrane are all part of normal hearing function. The vibration is then transmitted to the cochlea via the ossicles (malleus, incus, and stapes).
The most common hearing loss causes are auricle or helix abnormal formation, cerumen impaction, ear canal foreign bodies, otitis externa, ossicular chain dysfunction or fixation, and middle ear effusion. Muffling of speech and other sounds, trouble hearing consonants, avoidance of some social settings, and others are some of the common hearing loss symptoms.
Several methods, such as physical examination, general screening tests, and audiometer tests, are the most common tests used for hearing loss diagnosis.
Find out more about hearing loss treatment drugs @Drugs for Hearing Loss Treatment
A snapshot of the Hearing Loss Pipeline Drugs mentioned in the report:
| Drugs | Company | Phase | MoA | RoA |
| STR001 | Strekin | Phase III | Peroxisome proliferator-activated receptor gamma agonist | Intratympanic; Oral |
| FX 322 | Frequency Therapeutics | Phase II | Stem cell stimulant | Intratympanic |
| Arazasetron | Sensorion | Phase II/III | Serotonin 3 receptor antagonist | Oral |
| PIPE 505 | Pipeline Therapeutics | Phase I/II | Amyloid precursor protein secretase inhibitor | Intratympanic |
| OTO 413 | Otonomy | Phase I/II | Brain derived neurotrophic factor agonist | Intratympanic |
| DB OTO | Decibel Therapeutics | IND | OTOF protein expression stimulant | NA |
Learn more about the emerging hearing loss pipeline therapies @Hearing Loss Clinical Trials
Hearing Loss Therapeutics Assessment
The hearing loss pipeline report proffers an integral view of the hearing loss emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Hearing Loss Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Oral, Intratympanic
- Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
- Therapeutics Assessment By Mechanism of Action: Amyloid precursor protein secretase inhibitors, Stem cell stimulants, Calcineurin inhibitors, Serotonin 3 receptor antagonists, Brain derived neurotrophic factor agonists, Peroxisome proliferator-activated receptor gamma agonists, Gene transference, OTOF protein expression stimulants
- Key Hearing Loss Companies: Sensorion, Pipeline Therapeutics, Frequency Therapeutics, Otonomy, Inc., Strekin AG, Heyu (Suzhou) Pharmaceutical Technology Co., Ltd, Sound Pharmaceuticals Incorporated, Novartis, Gateway Biotechnology, Inc., Decibel Therapeutics, Akouos, Acousia Therapeutics GmbH, AGTC, BridgeBio Inc., Lineage Cell Therapeutics, Inc., Rinri Therapeutics Ltd., Autifony Therapeutics, AudioCure Pharma GmbH, Anida Pharma Inc., Mogrify, Astellas Pharma Inc., Altamira Therapeutics, Myrtelle, Hoba Therapeutics, Perha Pharmaceuticals, and others
- Key Hearing Loss Pipeline Therapies: PIPE 505, FX-322, SENS-401, OTO-413, STR001, HY01, SPI-1005, CGF166, Zonisamide, DB-OTO, AAV.103, AAV.104, DB-020, AK-OTOF, ACOU085, ACOU082, OTO-825, OTO-6XX, OTO-510, ,BBP-815, FX-345, Auditory Neuronal Cell Therapy, AC102, AP-001, AM-111, HB-097, and others
Dive deep into rich insights for new drugs for hearing loss treatment, visit @Hearing Loss Drugs
Table of Contents
| 1. | Hearing Loss Pipeline Report Introduction |
| 2. | Hearing Loss Pipeline Report Executive Summary |
| 3. | Hearing Loss Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Hearing Loss Clinical Trial Therapeutics |
| 6. | Hearing Loss Pipeline: Late Stage Products (Pre-registration) |
| 7. | Hearing Loss Pipeline: Late Stage Products (Phase III) |
| 7.1 | STR001: Strekin |
| 8. | Hearing Loss Pipeline: Mid Stage Products (Phase II) |
| 8.1 | FX 322: Frequency Therapeutics |
| 9. | Hearing Loss Pipeline: Early Stage Products (Phase I/II) |
| 9.1 | OTO 413: Otonomy |
| 10. | Hearing Loss Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Hearing Loss Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Hearing Loss Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the hearing loss pipeline therapeutics, reach out @Hearing Loss Treatment Drugs
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