'In 2021, Decibel made significant progress across our pipeline and towards our goal to bring transformative treatments to patients with hearing and balance disorders. We are on track to meet a number of important milestones in 2022, including the initiation of the first clinical trial of our lead gene therapy candidate, DB-OTO, designed to treat congenital hearing loss resulting from an otoferlin deficiency,' said
Pipeline Highlights and Upcoming Milestones:
Gene Therapies for Congenital, Monogenic Hearing Loss
On Track to Achieve DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) to the
Presented New Preclinical Data at the 45th Annual
Announced AAV.104
Product Candidate Selection for AAV.103 Program Anticipated in 2022: Decibel intends to select a product candidate for its AAV.103 program to restore hearing to individuals with a gap junction beta-2 (GJB2) deficiency, the most common cause of autosomal recessive, non-syndromic, congenital hearing loss.
Gene Therapies for Hair Cell Regeneration
Plans to Announce AAV.201 Program Target(s): Decibel continues to advance gene therapy programs for regeneration of hair cells in the vestibule for the treatment of bilateral vestibulopathy (BVP). Decibel plans to announce the program target(s) for its AAV.201 program in 2022. Our AAV.201 program is an AAV-based gene therapy that utilizes a proprietary supporting cell-selective promoter to express ATOH1 in combination with an additional factor. Our AAV.201 program aims to restore balance by promoting regeneration of Type I and Type II hair cells in the vestibular system.
Otoprotection Therapeutic
Interim Results from Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss Expected in the First Half of 2022: Decibel expects to report the results of an interim analysis from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss, a serious and debilitating condition for which there are no approved therapies, in the first half of 2022. Cisplatin, a commonly used chemotherapy agent, is known to cause hearing loss, tinnitus and speech recognition difficulty. DB-020 comprises a proprietary formulation of sodium thiosulfate that has been optimized for delivery to the ear. DB-020 is designed to protect hearing without interfering with cisplatin's anti-cancer activity by locally disabling cisplatin in the cochlea.
About
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Decibel's strategy, future operations, prospects, plans, objectives of management, the therapeutic potential for Decibel's product candidates and preclinical programs, the potential benefits of cell-selective expression, the expected timeline for submitting investigational new drug applications and clinical trial applications, initiating clinical trials, reporting clinical trial results and achieving other anticipated milestones, expectations regarding the translation of preclinical findings to human disease and the sufficiency of Decibel's existing cash resources for the period anticipated, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'objective,' 'ongoing,' 'plan,' 'predict,' 'project,' 'potential,' 'should,' or 'would,' or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Decibel may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials, the timing of and Decibel's ability to submit and obtain approval to initiate clinical development of its program candidates, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, whether Decibel's cash resources are sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, uncertainties related to the impact of the COVID-19 pandemic on Decibel's business and operations, as well as the risks and uncertainties identified in Decibel's filings with the
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