BOSTON — Decibel Therapeutics, a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced that their clinical product candidate, DB-020, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). DB-020 is an investigational therapy for the prevention of cisplatin-induced hearing loss, a serious and debilitating condition for which there are no currently approved therapies.
“Cisplatin remains one of the most effective tools we have to treat solid tumors in many patients. Unfortunately, it is associated with significant and irreversible hearing loss and tinnitus in the majority of patients who receive the drug,” said Patrick Cobb, M.D., Medical Director, Oncology Research at St. Vincent Healthcare and an investigator in an ongoing Phase 1b clinical trial with DB-020. “I’ve seen first-hand the adverse impact that cisplatin-induced hearing loss has on my patients’ lives and I’m encouraged by the potential to mitigate what has previously been an unavoidable, permanent consequence for these patients.”
Decibel is conducting a Phase 1b randomized, double-blind, placebo-controlled, multicenter clinical trial intended to explore the ability of DB-020 to prevent cisplatin-related ototoxicity, which often includes hearing loss, tinnitus and speech recognition problems. DB-020 is being administered to cancer patients for the prevention of cisplatin-induced damage to the inner ear. In this trial, DB-020 is injected into the patient’s ear shortly before each cycle of cisplatin. The active ingredient, sodium thiosulfate, then diffuses into the cochlea, where it irreversibly binds to cisplatin and prevents it from destroying the sensitive cells necessary for hearing, while not limiting the beneficial anti-tumor effect of cisplatin as a chemotherapy. The statistical power of the study is increased as patients serve as their own control, with one ear receiving treatment with DB-020 and the other receiving placebo.
“Fast Track designation is expected to enable us to advance on our goal to provide a meaningful treatment option that prevents patients from experiencing ototoxic effects of cisplatin without risking interference with its important anti-cancer efficacy. We look forward to working with the FDA as we progress our DB-020 clinical program,” said Laurence Reid, Ph.D., Chief Executive Officer of Decibel.
FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs that are being developed to treat serious conditions and fill an unmet medical need. The purpose of the designation is to bring important new drugs to patients earlier across a wide range of diseases.
About DB-020
DB-020 is an investigational therapy for the prevention of cisplatin-induced hearing loss. Decibel completed a randomized, double-blind, placebo-controlled Phase 1 clinical trial of DB-020 in healthy volunteers, in which DB-020 was well tolerated. An ongoing, Phase 1b randomized, double-blind, placebo-controlled, multicenter clinical trial is assessing safety and efficacy in patients receiving cisplatin chemotherapy. Cisplatin, a commonly used chemotherapy agent, is known to cause hearing loss, tinnitus and speech recognition difficulty. DB-020 comprises a proprietary formulation of sodium thiosulfate, or STS, which has been optimized for delivery to the ear. By locally disabling cisplatin in the cochlea, DB-020 is designed to protect hearing without interfering with cisplatin’s anti-cancer activity.
About Decibel Therapeutics, Inc.
Decibel 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 a world in which the privileges of hearing and balance are available to all. For more information about Decibel Therapeutics, please visit www.decibeltx.com or follow @DecibelTx.