Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology
company dedicated to discovering and developing transformative
treatments to restore and improve hearing and balance, today
reported positive top-line results from an interim analysis of its
ongoing 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.
Cisplatin, one of the most commonly used chemotherapeutic agents,
has severe dose-limiting side effects, including ototoxicity, which
leads to permanent hearing loss in many patients. There are no
approved therapies to prevent or treat cisplatin-induced
ototoxicity.
Patients enrolled in the Phase 1b clinical trial
were randomized to receive one of two doses of DB-020 in one ear
while the contralateral ear received placebo, enabling each patient
to serve as their own control. Patients were administered DB-020
and placebo up to three hours prior to each cisplatin infusion.
Consistent with the results of a Phase 1 clinical trial of DB-020
previously completed by the Company in healthy volunteers, data
from the interim analysis demonstrated that DB-020 was well
tolerated, with adverse events generally mild to moderate. In the
data from the interim analysis, 88% of patients experienced
ototoxicity in their placebo-treated ear, and of these patients,
87% were partially or completely protected from ototoxicity in
their DB-020-treated ears.
“These data support the approach and rationale for DB-020 and
represent an important step forward in the development of DB-020
for patients receiving cisplatin chemotherapy. We are tremendously
encouraged by the favorable safety profile and protection against
ototoxicity we have observed in the trial as of the interim
analysis,” said John Lee, Chief Development Officer of Decibel.
“These promising data support continued development of DB-020 to
prevent or minimize cisplatin-induced hearing loss, an irreversible
condition for which there are currently no available
treatments.”
The interim analysis includes data collected as of February 4,
2022 from 19 cisplatin-naïve cancer patients being treated with
high doses of cisplatin every 21 or 28 days. Of the 19 patients in
the interim analysis, 17 patients had evaluable audiograms at
baseline and after being dosed with DB-020 in one ear and placebo
in the contralateral ear in conjunction with their prescribed
infusion of cisplatin chemotherapy. Ototoxicity was defined
according to the American Speech-Language-Hearing-Association
(ASHA) criteria for significant ototoxic change.
Key findings:
- DB-020 was generally well tolerated, with no significant safety
issues observed.
- DB-020, administered prior to cisplatin, had no apparent effect
on systemic cisplatin levels.
- 13 of 17 (76.5%) patients experienced cisplatin-induced
ototoxicity in the placebo ear after the first cycle of cisplatin;
15 of 17 (88.2%) patients experienced cisplatin-induced ototoxicity
in the placebo ear by the last evaluable test.
- Placebo-treated ears lost approximately 30dB on average from
baseline in high frequencies, shifting patients from normal or
slight hearing loss to moderate hearing loss (two hearing loss
categories) on average.
- In the 15 patients who experienced ototoxicity in the placebo
ear by the last evaluable test, DB-020 protected 13 (87%) from
ototoxicity in their DB-020-treated ear.
- 8 of 15 (53.3%) were completely protected, and 5 of 15 (33.3%)
were partially protected. (Complete protection was defined as no
change in hearing from baseline in the ear that received DB-020
according to the ASHA ototoxicity criteria in the clinically
assessed range.)
- Ears treated with DB-020 lost approximately 8dB on average from
baseline.
- DB-020 reduced cisplatin-induced loss of speech audibility by
80% as measured by the Speech Intelligibility Index, suggesting
treatment with DB-020 may reduce the risk of needing assistive
hearing devices after receiving cisplatin.
“Cisplatin remains an important chemotherapy for the treatment
of multiple cancer types, both as a single agent and in combination
therapy, and is used routinely in my patients,” said Dr. Danny
Rischin, Director of the Division of Cancer Medicine and Head of
the Department of Medical Oncology at Peter MacCallum Cancer
Centre, Melbourne, Australia. “Administration of DB-020 was
generally well tolerated, and did not appear to alter systemic
cisplatin levels, reducing concern of impacting the
chemotherapeutic benefits of cisplatin on cancer management.”
“Decibel’s trial underscores the magnitude of hearing loss
experienced by cisplatin-naïve cancer patients receiving cisplatin
chemotherapy even after a single cycle of cisplatin,” said Dr. Ben
Panizza, Director of the Queensland Head and Neck Cancer Centre,
Brisbane, Australia. “Decibel’s interim analysis provides evidence
that DB-020 has exciting potential to prevent cisplatin-induced
hearing loss and we look forward to continuing to evaluate the
effectiveness of DB-020.”
“We believe these positive data showcase the integrated
capabilities that Decibel has implemented to develop innovative
therapeutics for conditions of the inner ear. We look forward to
reporting additional data from the interim analysis of our ongoing
clinical trial of DB-020 at an upcoming medical conference, as we
continue to advance our broader pipeline, focused on creating a
world of connection for people with hearing and balance disorders,”
said Laurence Reid, Ph.D., Chief Executive Officer of Decibel.
Webcast and Conference CallDecibel management
will host a webcast regarding these interim analysis results today,
Tuesday, June 28, 2022 at 8:00 a.m. EDT. The live webcast may be
accessed online.
A replay of the webcast will be available online in the investor
relations section of the Decibel website at www.decibeltx.com and
will be archived there for 90 days.
About the Phase 1b Clinical TrialThe Phase 1b
clinical trial of DB-020 is an ongoing, randomized, double-blind,
placebo-controlled, multicenter trial designed to determine safety
and tolerability of transtympanic injections of DB-020 in cancer
patients receiving high doses of cisplatin. Audiometric
measurements are made at the baseline before the first cisplatin
infusion, before each subsequent cycle of cisplatin, and at the end
of treatment in order to assess cisplatin-induced ototoxicity. ASHA
criteria for significant ototoxic change are defined as either a
≥20 decibel (dB) decrease at any one test frequency, ≥10 dB
decrease at any two adjacent frequencies, or loss of response at
three consecutive frequencies where responses were previously
obtained. Ototoxicity is evaluated from baseline to post-cisplatin
administration timepoints in each ear and comparative ototoxicity
measurements are made between the ears dosed with DB-020 and
placebo in each patient. Partial protection is defined using ASHA
Ototoxicity Criteria being applied to between ear changes.
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 program, 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.
About DB-020DB-020 is a proprietary formulation
of sodium thiosulfate (STS) optimized for local delivery to the ear
and is being investigated for its potential to protect against
cisplatin-induced hearing loss without impacting the beneficial
effect of cisplatin. DB-020 is designed to achieve high cochlear
concentrations of STS following a local injection through the ear
drum, or transtympanically, into the middle ear. Transtympanic
injection is a brief, minimally invasive, routine, office-based
procedure performed by ENTs and is generally well-tolerated. A
randomized, double-blind, placebo-controlled Phase 1 clinical trial
of DB-020 in normal healthy volunteers was completed in 2019. A
randomized, double-blind, placebo-controlled, multicenter Phase 1b
clinical trial of DB-020 in patients undergoing treatment with
cisplatin is ongoing. For more information on the study, visit
https://clinicaltrials.gov/ct2/show/NCT04262336
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 interim data from a clinical trial will be
predictive of the results of the trial and future 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, 2022
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.julie.seidel@sternir.com212-362-1200
Media Contact:Chris RaileyTen Bridge
Communicationschris@tenbridgecommunications.com 617-834-0936
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