sodium thiosulfate (DB-020) / Regeneron - LARVOL DELTA

Randomized Phase Ib Clinical Trial of DB-020 Intratympanic Injections to Reduce High-Dose Cisplatin Ototoxicity. (PubMed, J Clin Oncol) - "DB-020 IT injections were tolerated by patients and showed meaningful reductions in cisplatin ototoxicity."

Journal • P1 data • Otorhinolaryngology • Pain

A phase 1 clinical trial of DB-020 intratympanic injections administered prior to high-dose cisplatin chemotherapy to reduce ototoxicity. (ASCO 2024) - P1b | "In this initial clinical trial experience, there was no significant safety signal, and DB-020 IT injections showed a meaningful reduction in CP-induced ototoxicity."

Clinical • P1 data • Head and Neck Cancer • Lung Cancer • Oncology • Otorhinolaryngology • Pain • Solid Tumor

Decibel Therapeutics Reports Second Quarter 2023 Financial Results and Corporate Update (GlobeNewswire) - "In July 2023, Decibel received FDA Breakthrough Therapy Designation for DB-020, a novel, proprietary formulation of sodium thiosulfate (STS), designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy....Research and development expenses were $12.8 million for the second quarter of 2023, compared to $11.2 million for the same period in 2022. The increase in research and development expenses for the second quarter 2023 was primarily due to higher clinical development...and clinical costs for DB-020, and higher personnel-related costs due to increased headcount, wages and stock-based compensation."

Breakthrough therapy designation • Commercial • Oncology

Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - P1b | N=22 | Completed | Sponsor: Decibel Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Oncology

A phase 1 clinical trial of DB-020 intratympanic injections administered prior to high dose cisplatin chemotherapy to reduce ototoxicity. (ASCO 2023) - P1b | "In this initial clinical trial experience there was no significant safety signal, and DB-020 IT injections showed a meaningful reduction in cisplatin ototoxicity. These results warrant further clinical development. Clinical trial information: NCT04262336."

Clinical • P1 data • Head and Neck Cancer • Lung Cancer • Oncology • Otorhinolaryngology • Pain • Solid Tumor

Decibel Therapeutics Reports First Quarter 2023 Financial Results and Corporate Update (GlobeNewswire) - "DB-020 Phase 1b Clinical Trial Data to Be Presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting: Decibel will present data from the Phase 1b clinical trial of DB-020, its product candidate for prevention of cisplatin-induced hearing loss in patients receiving cisplatin chemotherapy. In the interim results from the trial, DB-020 demonstrated reduced ototoxicity, a favorable safety and tolerability profile and no observed effect on systemic cisplatin pharmacokinetics (PK) in such patients. The Company is seeking advice from regulatory agencies concerning the future development of DB-020."

P1 data • Oncology

Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - P1b | N=22 | Active, not recruiting | Sponsor: Decibel Therapeutics | Recruiting ➔ Active, not recruiting | N=70 ➔ 22 | Trial completion date: Dec 2023 ➔ Jul 2023 | Trial primary completion date: Dec 2022 ➔ Jul 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology

Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - P1b | N=70 | Recruiting | Sponsor: Decibel Therapeutics | Trial completion date: Mar 2022 ➔ Dec 2023 | Trial primary completion date: Sep 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Oncology

Study to Evaluate Safety and Efficacy of DB-020 to Protect Hearing in Patients Receiving Cisplatin for Cancer Treatment (clinicaltrials.gov) - P1b; N=70; Recruiting; Sponsor: Decibel Therapeutics; Trial completion date: Oct 2021 ➔ Mar 2022; Trial primary completion date: Apr 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Oncology

"We may be sheltering in place but are still #fightingacure @AmericanCancer @ILDiscoveryBall #WhereIRise #db2020" (@Iheartsap)

Phase 1 study to evaluate safety, tolerability and pharmacokinetics of a novel intra-tympanic administered thiosulfate to prevent cisplatin-induced hearing loss in cancer patients. (PubMed, Invest New Drugs) - "DB-020 is being developed as a novel formulation of sodium thiosulfate pentahydrate in 1% sodium hyaluronate for intratympanic injection (IT), enabling the delivery of high concentrations of thiosulfate into the cochlea prior to cisplatin administration. Furthermore, DB-020 was safe and well tolerated with most adverse events reported as transient, of mild-to-moderate severity and related to the IT administration procedure. These results support the design and execution of the ongoing proof-of-concept study, DB-020-002, to assess otoprotection using DB-020 in cancer patients receiving cisplatin without negatively impacting cisplatin anti-tumor efficacy."

Clinical • Journal • P1 data • PK/PD data