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New Drug for Hearing Loss Approved for Clinical Trials
Research Report

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Plans call for an initial clinical trial to start in H1/23 in both the U.S. and the United Kingdom, where the biopharma recently received approval to proceed, noted an H.C. Wainwright & Co. report.

Decibel Therapeutics Inc. (DBTX:NASDAQ) received a green light from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom (U.K.) to conduct clinical trials on DB-OTO, the biopharma's lead gene therapy candidate, reported H.C. Wainwright & Co. analyst Dr. Joseph Pantginis in a Jan. 24 research note.

"The newly authorized U.K. clinical trial application (CTA) is part of an international regulatory strategy for [the] development of DB-OTO, which includes a CTA submission to the Spanish Agency of Medicines and Medical Devices and the recently cleared investigational new drug [application] in the U.S.," explained Pantginis.

Also of note, Decibel's stock is currently trading at about US$3.26 per share, way below H.C. Wainwright's US$23 price target on it. This price difference represents a significant potential return for investors in the Buy-rated biopharma.

Studies To Start Soon

With the U.K. clearance in hand, the Massachusetts firm plans to start a Phase 1/2 dose escalation study of DB-OTO in H1/23. The gene therapy will be evaluated in pediatric patients with congenital hearing loss due to a deficiency of the protein otoferlin, a condition for which no current drug treatments exist.

Also of note, Decibel's stock is currently trading at about US$3.26 per share, way below H.C. Wainwright's US$23 price target on it.

Given Decibel received investigational new drug clearance for DB-OTO from the U.S. Food and Drug Administration before the U.K. approval, its plans call for a similar study in the States, also to commence in H1/23.

The biopharma is developing DB-OTO as part of a strategic research collaboration with Regeneron, which recently extended the agreement to Nov. 15, 2023.

"DB-OTO now is the second product candidate in Decibel's pipeline to advance into clinical trials," noted Pantginis.

Second Asset in Development

The first was DB-020, a proprietary formulation of sodium thiosulfate (STS) designed to prevent hearing loss in cancer patients receiving cisplatin chemotherapy.

Recently announced, interim Phase 1b proof-of-concept trial data showed that DB-020 partly or fully prevented hearing loss in almost all study participants, and was safe and well tolerated, relayed Pantginis. The most common side effect patients experienced was ear pain that quickly subsided. Importantly, DB-020 did not interfere with systemic cisplatin levels.

"We believe the results provide the expected clinical validation for the localized delivery of STS in patients treated with cisplatin and support the further development of DB-020," Pantginis wrote.

Decibel plans to meet with key opinion leaders and the U.S. Food and Drug Administration to determine the best path toward approval for DB-020.

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Disclosures For H.C. Wainwright & Co., Decibel Therapeutics Inc.,  January 24, 2023

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Joseph Pantginis, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Decibel Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of December 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Decibel Therapeutics, Inc.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Decibel Therapeutics, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from Decibel Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Decibel Therapeutics, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request.

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