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Decibel Therapeutics, Inc. (Nasdaq: DBTX) is a pioneering biotechnology company headquartered in Boston, Massachusetts. Founded in 2015 by Third Rock Ventures and SR One, the company is focused on discovering and developing innovative treatments to protect, repair, and restore hearing. Hearing loss affects approximately 50 million people in the United States and 360 million worldwide, making it the most prevalent form of sensory impairment. Decibel Therapeutics aims to address this significant unmet medical need by combining cutting-edge hearing science with leading diagnostic tools, biological insights, and therapeutic delivery techniques.
Decibel Therapeutics has built a proprietary platform that integrates single-cell genomics, bioinformatic analyses, precision gene therapy technologies, and deep expertise in inner ear biology. This platform is being leveraged to advance a pipeline of breakthrough therapies targeted to specific indications and patient populations. Among its leading projects is DB-OTO, a gene therapy candidate aimed at treating congenital, monogenic hearing loss caused by otoferlin deficiency. The company is currently conducting the CHORD clinical trial with six active sites in prestigious institutions across three countries.
In addition to gene therapies for congenital hearing loss, Decibel is developing treatments for acquired hearing and balance disorders. The company's vision is to make the privileges of hearing and balance available to all.
Recent corporate developments include a definitive agreement for acquisition by Regeneron Pharmaceuticals, reflecting the potential of Decibel's gene therapy programs. Financial results for the second quarter of 2023 were strong, and the company continues to focus on its key milestones, including advancing its gene therapy pipeline and achieving clinical trial progress.
For more information about Decibel Therapeutics, please visit www.decibeltx.com or follow them on Twitter.
Decibel Therapeutics (Nasdaq: DBTX) announced the FDA's clearance of its IND and UK MHRA's CTA for the CHORD™ clinical trial, set to begin in H1 2023. This global Phase 1/2 trial will evaluate DB-OTO in pediatric patients, including those younger than 2. The company presented data at the ARO MidWinter Meeting, emphasizing DB-OTO's strong safety profile. Financially, Decibel's cash reserves declined to $104.6 million from $162.3 million year-over-year, with increased R&D expenses of $40.3 million in 2022. Despite higher expenses, the company expects its cash to fund operations into H1 2024, signaling a cautious yet optimistic outlook.
Decibel Therapeutics (Nasdaq: DBTX) announced that CEO Laurence Reid, Ph.D., will present a corporate overview at the SVB Securities Global Biopharma Conference on February 16, 2023, at 9:20 a.m. E.T. The presentation will be accessible via a live webcast on the Decibel Therapeutics website, with an archived replay available for 90 days post-event. The company focuses on innovative treatments to enhance hearing and balance, employing a unique platform that integrates single-cell genomics, precision gene therapy, and inner ear biology. Key to their pipeline is DB-OTO, a gene therapy program aimed at addressing congenital hearing loss.
BOSTON, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX) announced its participation in the 46th Annual MidWinter Meeting of the Association for Research in Otolaryngology (ARO) from February 11–15, 2023, in Orlando, Florida. The company will present findings related to its gene therapy programs, including new data on its lead candidate, DB-OTO, and interim results from the Phase 1b trial of DB-020 for cisplatin chemotherapy patients. Presentations will be made by Kathryn Ellis, Ph.D., and John Lee, among others, covering various aspects of gene therapy and its applications for hearing loss and ototoxicity.
Decibel Therapeutics (Nasdaq: DBTX) announced the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) authorized its Clinical Trial Application (CTA) for DB-OTO, expanding its Phase 1/2 clinical trial to pediatric patients aged two years and younger. This approval is part of a broader international strategy, following an Investigational New Drug (IND) clearance in the U.S. and a CTA in Spain. DB-OTO aims to address profound congenital hearing loss caused by otoferlin gene mutations. The trial will evaluate safety and efficacy, with initial data expected in the first quarter of 2024.
Decibel Therapeutics (DBTX) announced FDA clearance for its IND application for DB-OTO, a gene therapy for otoferlin-related hearing loss, enabling a Phase 1/2 trial in pediatric patients. The company also submitted CTAs in the UK and Spain. As of September 30, 2022, Decibel’s cash and equivalents were $111.9 million, down from $162.3 million in December 2021. R&D expenses rose to $10 million, reflecting increased development efforts for DB-OTO. The firm anticipates that its cash reserves will support operations into 2024.
Decibel Therapeutics (DBTX) announced the submission of Clinical Trial Applications for a Phase 1/2 trial of DB-OTO, a gene therapy aimed at restoring hearing in pediatric patients with profound congenital hearing loss due to otoferlin deficiency. This significant milestone marks progress in their collaboration with Regeneron Pharmaceuticals. The therapy has previously received Orphan Drug and Rare Pediatric Disease designations from the FDA. The company aims to advance treatment options for hearing disorders and strengthen its clinical development strategy.
Decibel Therapeutics (Nasdaq: DBTX) has received FDA clearance for its Investigational New Drug (IND) application to start a Phase 1/2 clinical trial of DB-OTO, a gene therapy targeting congenital hearing loss in pediatric patients. This program aims to enable hearing restoration by administering otoferlin, a protein crucial for auditory nerve signaling. Preclinical studies showed promising results, including durable auditory responses in rodent models. The company collaborates with Regeneron, marking a significant step in addressing the unmet needs in pediatric hearing loss treatments.
Decibel Therapeutics (Nasdaq: DBTX) has appointed Kevin F. McLaughlin to its Board of Directors. McLaughlin brings over 40 years of experience in biopharma and finance, having previously served as CFO at Acceleron Pharma until its acquisition by Merck in 2021. His leadership is expected to provide strategic insights as Decibel focuses on advancing gene therapies for hearing loss and balance disorders. Underlining its commitment, Decibel continues to develop its proprietary platform aimed at meeting significant unmet medical needs in these fields.
Decibel Therapeutics (Nasdaq: DBTX) announced that CEO Laurence Reid, Ph.D., will join a fireside chat at the Jefferies Cell and Genetic Medicine Summit on September 30, 2022, at 10:00 a.m. ET in New York City. This event will explore the company's efforts in developing innovative treatments aimed at restoring hearing and balance. A live webcast will be available on the Decibel Therapeutics website, with an archived version accessible for 90 days post-event. Decibel Therapeutics focuses on gene therapies for congenital and acquired hearing disorders.
Decibel Therapeutics (Nasdaq: DBTX) has submitted an IND application to the FDA for a Phase 1/2 clinical trial of DB-OTO, a gene therapy aimed at restoring hearing in pediatric patients with profound congenital hearing loss due to otoferlin deficiency. Developed in partnership with Regeneron Pharmaceuticals, DB-OTO utilizes an AAV-based dual-vector system designed to enable the expression of otoferlin in hair cells. This submission marks a significant milestone in addressing pediatric hearing loss, a condition lacking approved treatments. The trial is expected to begin in the first half of 2023, pending approval.
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