BOSTON–(BUSINESS WIRE)–Decibel Therapeutics, a development-stage biotechnology company developing novel regenerative therapeutics for hearing loss and balance disorders, today announced that Phase 1a trial results demonstrating the safety and tolerability of its lead candidate, DB-020, have been published in the peer-reviewed journal Investigational New Drugs. DB-020 is being developed for the prevention of cisplatin-induced hearing loss.
The Phase 1a trial showed that DB-020 was safe and well-tolerated in healthy volunteers and confirmed that administration of DB-020 resulted in only nominal systemic increases of sodium thiosulfate, suggesting that DB-020 should have no impact on the efficacy of cisplatin therapy throughout the body.
Based on the encouraging results of the Phase 1a study in healthy volunteers, Decibel has initiated a Phase 1b trial of DB-020 in patients undergoing treatment with cisplatin. The trial will evaluate both the safety and efficacy of DB-020 in preventing hearing loss.
Cisplatin is a widely used chemotherapy that often leads to hearing loss and related complications in patients being treated for cancer. Decibel’s DB-020 consists of a novel formulation of sodium thiosulfate – which inactivates cisplatin – optimized for delivery to the ear via routine intratympanic injection.
Decibel’s proprietary formulation will enable delivery of DB-020 locally to the inner ear via intratympanic injection, a procedure that can be performed in the infusion suite or clinic room prior to cisplatin administration. Because DB-020 can be delivered locally rather than systemically, it minimizes systemic exposure of sodium thiosulfate elsewhere in the body. This approach is designed to prevent hearing loss without interfering with cisplatin’s ability to kill cancer cells throughout the body. Moreover, because DB-020 can be administered directly to the ear prior to each cycle of chemotherapy, it may provide greater protection for the ear from the negative effects of cisplatin.
“Publication of the Phase 1a data provides early validation of the safety and ease of delivery of DB-020, and we look forward to exploring in the Phase 1b study its potential to address the hearing loss and tinnitus that have been an unavoidable consequence of cancer treatment for many people,” said Vissia Viglietta, M.D., Ph.D., vice president of clinical development at Decibel. “This is an important step in our quest to help patients with hearing and balance disorders, particularly the many patients who survive cancer only to have their hearing damaged after undergoing chemotherapy.”
About Decibel Therapeutics, Inc.
Decibel Therapeutics, a development-stage biotechnology company, has established the world’s first comprehensive drug discovery, development and translational research platform for hearing loss and balance disorders. Decibel is advancing a portfolio of discovery-stage programs aimed at restoring hearing and balance function to further our vision of a world in which the benefits and joys of hearing are available to all. Decibel’s lead therapeutic candidate, DB-020, is being investigated for the prevention of ototoxicity associated with cisplatin chemotherapy. For more information about Decibel Therapeutics, please visit decibeltx.com or follow @DecibelTx.