Decibel Therapeutics to Present DB-020 Phase 1b Clinical Trial Data at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting
June 01 2023 - 4:30PM
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
ototoxicitySession and track: Head and Neck Cancer
– Advanced/Metastatic Disease Abstract number:
6043Poster board number: 35Date and
time: Monday, June 5th, 1:15 p.m. CDT
About Decibel TherapeuticsDecibel 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
StatementsThis 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.
Investor Contact:Julie SeidelStern IR,
Inc.212-362-1200Julie.seidel@sternir.comMedia
Contact:Chris RaileyTen Bridge
Communications617-834-0936chris@tenbridgecommunications.com
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