Item 8.01 Other Events.
On October 17, 2022, Decibel Therapeutics, Inc. (the "Company") announced that
it has received clearance from the U.S. Food and Drug Administration (the "FDA")
for its investigational new drug ("IND") application to initiate a Phase 1/2
clinical trial in pediatric patients of DB-OTO, its lead gene therapy product
candidate.
The Phase 1/2 dose escalation clinical trial is designed to evaluate the safety,
tolerability and efficacy of DB-OTO in pediatric patients with congenital
hearing loss due to an otoferlin deficiency. In addition to safety and
tolerability endpoints, established, clinically relevant, objective and
behavioral measurements of hearing will be used as efficacy endpoints in the
clinical trial. The auditory brainstem response, which was used to characterize
dose-response of DB-OTO after intra-cochlear delivery in translational studies,
will serve as an early, objective, clinically accepted readout of hearing
thresholds in the clinical trial.
Based on discussions with the FDA during the IND review period, the Company
expects the first two participants in the U.S. portion of the Phase 1/2 clinical
trial will be as young as seven years of age and that subsequent participants
will include children as young as two years of age and infants younger than two
years of age. The Company intends to provide an update on the design of the
clinical trial in the future. The DB-OTO IND is part of an international
regulatory strategy for development of DB-OTO, which also includes plans to
submit one or more clinical trial applications in Europe.
Forward-Looking Statements
This Form 8-K contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of historical facts,
contained in this Form 8-K, including statements regarding the Company's
strategy, future operations, prospects, plans, objectives of management, the
therapeutic potential for the Company's product candidates and preclinical
programs, the potential benefits of cell-selective expression, plans to submit
one or more clinical trial applications in Europe and the expected timeline for
initiating a Phase 1/2 clinical trial of DB-OTO 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. The Company 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 timing of and the Company's ability to
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 the Company'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 the Company's business and operations, as
well as the risks and uncertainties identified in the Company's filings with the
Securities and Exchange Commission ("SEC"), including those risks detailed under
the caption "Risk Factors" in the Company's Quarterly Report on Form 10-Q for
the quarterly period ended June 30, 2022 and in other filings the Company may
make with the SEC. In addition, the forward-looking statements included in this
Form 8-K represent the Company's views as of the date of this Form 8-K. The
Company anticipates that subsequent events and developments will cause its views
to change. However, while the Company 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 the Company's views as of any date subsequent to the date of this
Form 8-K.
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