Decibel Therapeutics to Present DB-020 Phase 1b Clinical Trial Data at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting

By: Decibel Therapeutics, Inc. via GlobeNewswire

June 01, 2023 at 16:30 PM EDT

BOSTON, June 01, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced that it will present at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois, June 2-6, 2023. The Company will present a poster summarizing data from the interim analysis of the Phase 1b clinical trial of DB-020, a novel, proprietary formulation of sodium thiosulfate (STS) designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy.

“Hearing loss and tinnitus are significant, often debilitating sequelae of cisplatin-induced ototoxicity, for which there are currently no approved therapies. Cisplatin remains an important chemotherapy for the treatment of multiple cancer types, and DB-020 is designed to protect the patient against cisplatin-induced ototoxicity,” said John Lee, Chief Development Officer of Decibel. “Data from the Phase 1b clinical trial demonstrate that treatment with DB-020 may result in a meaningful reduction in cisplatin-associated ototoxicity and support its continued development to potentially provide a therapy for an irreversible condition.”

The Phase 1b clinical trial was a randomized, blinded study in which patients were dosed with DB-020 in one ear and placebo in the contralateral ear in conjunction with their prescribed infusion of cisplatin chemotherapy. Additional information about the clinical trial can be found at clinicaltrials.gov.

Decibel’s ASCO presentation includes additional ototoxicity measures, which are consistent with the previously reported topline interim analysis data showing that 87% of patients who experienced cisplatin-induced ototoxicity in their placebo-treated ear were protected from ototoxicity in their DB-020-treated ear. Treatment with DB-020 prior to cisplatin administration had no apparent effect on systemic cisplatin levels. DB-020 was generally well tolerated, with no serious adverse effects and no tympanic perforations.

Poster presentation details:

Title: A Phase 1 clinical trial of DB-020 tympanic injections administered prior to high dose cisplatin chemotherapy to reduce ototoxicity
Session and track: Head and Neck Cancer – Advanced/Metastatic Disease
Abstract number: 6043
Poster board number: 35
Date and time: Monday, June 5^th, 1:15 p.m. CDT

About Decibel Therapeutics
Decibel Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, one of the largest areas of unmet need in medicine. Decibel has built a proprietary platform that integrates single-cell genomics and bioinformatic analyses, precision gene therapy technologies and expertise in inner ear biology. Decibel is leveraging its platform to advance gene therapies designed to selectively replace genes for the treatment of congenital, monogenic hearing loss and to regenerate inner ear hair cells for the treatment of acquired hearing and balance disorders. Decibel’s pipeline, including its lead gene therapy product candidate, DB-OTO, to treat congenital, monogenic hearing loss, is designed to deliver on our vision of creating a world of connection for people with hearing and balance disorders. For more information about Decibel Therapeutics, please visit www.decibeltx.com or follow us on Twitter.

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, 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 Securities and Exchange Commission (SEC), including those risks detailed under the caption “Risk Factors” in Decibel’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023 and in other filings Decibel may make with the SEC. In addition, the forward-looking statements included in this press release represent Decibel’s views as of the date of this press release. Decibel anticipates that subsequent events and developments will cause its views to change. However, while Decibel may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Decibel’s views as of any date subsequent to the date of this press release.

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Stern IR, Inc.
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Julie.seidel@sternir.com

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