DelveInsight’s, “Hearing Los Pipeline Insight 2023” report provides comprehensive insights about 35+ companies and 45+ pipeline drugs in the Hearing Loss pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Key takeaways from the Hearing Loss Pipeline Insight 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.
- The Hearing Loss Companies and academics are working to assess challenges and seek opportunities that could influence Hearing Loss R&D. The Hearing Loss pipeline therapies under development are focused on novel approaches to treat/improve Hearing Loss.
Recent Development Activities in the Hearing Loss Treatment Landscape
- 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.
Discover the recent advances in hearing loss treatment drugs @ Hearing Loss Pipeline Outlook Report
Hearing Loss Overview
Hearing loss is an extremely common medical condition, progressing in incidence and severity with age. The affected population is also vast, varying between neonates to elderly patients, and is nearly omnipresent in the 70+ age group. Normal hearing function involves sound waves arriving at the auricle, passing through the external auditory canal (EAC), causing a vibration of the tympanic membrane. Vibration is then transmitted via the ossicles (malleus, incus, stapes) to the cochlea. Subsequently, hair cells inside the cochlea stimulate the eighth cranial nerve that transfers the stimuli to the brain. Processing of crude sounds occurs in the higher cortices of the brain, and this includes the comprehension of language. Hearing loss can be conductive, sensorineural, or mixed.
Hearing Loss Pipeline Report
In the Hearing Loss report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Hearing Loss collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Hearing Loss Emerging Drugs
PIPE 505: Pipeline Therapeutics
PIPE-505 is a gamma secretase inhibitor that targets two pathways associated with sensorineural hearing loss and audibility. Currently, the drug is in Phase I/II stage of Clinical trial evaluation for the treatment of Sensorineural Hearing Loss.
FX 322: Frequency Therapeutics
FX-322 is designed to treat the underlying cause of sensorineural hearing loss (SNHL) by regenerating sensory hair cells through activation of progenitor cells already present in the cochlea. Frequency’s lead asset FX-322 has shown the first-ever statistically significant and clinically meaningful hearing improvement signal in clinical trials. Three clinical studies in which a single dose of FX-322 was administered have shown hearing improvements in measures of speech perception. In addition, in all FX-322 studies, this drug candidate was observed to be well-tolerated with no serious drug-related adverse effects. FX-322 is currently in Phase II b study.
Arazasetron: Sensorion
Arazasetron (SENS-401), is a first-in-class drug candidate to treat Sudden Sensorineural Hearing Loss (SSNHL). It is aiming at treating or protecting against inner ear lesions that lead to nerve degeneration and sensory hair cell loss. It is protected by a solid intellectual property with two patent families.
Learn more about the emerging hearing loss pipeline therapies @ Hearing Loss Clinical Trials Analysis
Hearing Loss Therapeutics Assessment
There are approx. 35+ key companies which are developing the therapies for Hearing Loss. The companies which have their Hearing Loss drug candidates in the most advanced stage, i.e. phase II include, Frequency Therapeutics.
Hearing Loss Segmentation 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.
Find out more about hearing loss treatment drugs @ Hearing Loss Treatment Landscape
Scope of the Hearing Loss Pipeline Report
- Coverage- Global
- Hearing Loss Companies– 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.
- 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.
- Hearing Loss Segmentation: Phases, Product Type, Molecule Type, Mechanism of Action, Route of Administration
Table of Content
- Introduction
- Executive Summary
- Hearing Loss: Overview
- Hearing Loss Pipeline Therapeutics
- Hearing Loss Therapeutic Assessment
- Hearing Loss– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Drug name: Company name
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- FX 322: Frequency Therapeutics
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- Drug name: Company name
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug name: Company name
- Drug profiles in the detailed report…..
- Inactive Products
- Hearing Loss Key Companies
- Hearing Loss Key Products
- Hearing Loss- Unmet Needs
- Hearing Loss- Market Drivers and Barriers
- Hearing Loss- Future Perspectives and Conclusion
- Hearing Loss Analyst Views
- Hearing Loss Key Companies
- Appendix
Key Questions
Current Treatment Scenario and Emerging Therapies:-
- How many companies are developing Hearing Loss drugs?
- How many Hearing Loss drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hearing Loss?
- What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Hearing Loss therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Hearing Loss and their status?
- What are the key designations that have been granted to the emerging drugs?
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