Decibel Therapeutics (DBTX) Stock: Why It Surged 18.3%

By Amit Chowdhry ● Jun 29, 2022
  • The stock price of Decibel Therapeutics Inc (NASDAQ: DBTX) surged by 18.3% in the most recent trading session. This is why.

The stock price of Decibel Therapeutics Inc (NASDAQ: DBTX) – a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance – surged by 18.3% in the most recent trading session. Investors are responding positively to Decibel Therapeutics reporting positive top-line results from an interim analysis of its ongoing Phase 1b clinical trial of DB-020, a novel, proprietary formulation of sodium thiosulfate (STS) designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy. Cisplatin – one of the most commonly used chemotherapeutic agents – has severe dose-limiting side effects, including ototoxicity, which leads to permanent hearing loss in many patients. There are no approved therapies to prevent or treat cisplatin-induced ototoxicity.

The patients enrolled in the Phase 1b clinical trial were randomized to receive one of two doses of DB-020 in one ear while the contralateral ear received placebo, enabling each patient to serve as their own control. Patients were administered DB-020 and placebo up to three hours prior to each cisplatin infusion. Consistent with the results of a Phase 1 clinical trial of DB-020 previously completed by the Company in healthy volunteers, data from the interim analysis demonstrated that DB-020 was well tolerated, with adverse events generally mild to moderate. In the data from the interim analysis, 88% of patients experienced ototoxicity in their placebo-treated ear, and of these patients, 87% were partially or completely protected from ototoxicity in their DB-020-treated ears.

The interim analysis includes data collected as of February 4, 2022, from 19 cisplatin-naïve cancer patients being treated with high doses of cisplatin every 21 or 28 days. And of the 19 patients in the interim analysis, 17 patients had evaluable audiograms at baseline and after being dosed with DB-020 in one ear and placebo in the contralateral ear in conjunction with their prescribed infusion of cisplatin chemotherapy. Ototoxicity was defined according to the American Speech-Language-Hearing-Association (ASHA) criteria for significant ototoxic change.

Key findings:

1.) DB-020 was generally well tolerated, with no significant safety issues observed.

2.) DB-020, administered prior to cisplatin, had no apparent effect on systemic cisplatin levels.

3.) 13 of 17 (76.5%) patients experienced cisplatin-induced ototoxicity in the placebo ear after the first cycle of cisplatin; 15 of 17 (88.2%) patients experienced cisplatin-induced ototoxicity in the placebo ear by the last evaluable test.

a.) Placebo-treated ears lost approximately 30dB on average from baseline in high frequencies, shifting patients from normal or slight hearing loss to moderate hearing loss (two hearing loss categories) on average.

4.) In the 15 patients who experienced ototoxicity in the placebo ear by the last evaluable test, DB-020 protected 13 (87%) from ototoxicity in their DB-020-treated ear.

a.) 8 of 15 (53.3%) were completely protected, and 5 of 15 (33.3%) were partially protected. (Complete protection was defined as no change in hearing from baseline in the ear that received DB-020 according to the ASHA ototoxicity criteria in the clinically assessed range.)

b.) Ears treated with DB-020 lost approximately 8dB on average from baseline.

5.) DB-020 reduced cisplatin-induced loss of speech audibility by 80% as measured by the Speech Intelligibility Index, suggesting treatment with DB-020 may reduce the risk of needing assistive hearing devices after receiving cisplatin.

KEY QUOTE:

“These data support the approach and rationale for DB-020 and represent an important step forward in the development of DB-020 for patients receiving cisplatin chemotherapy. We are tremendously encouraged by the favorable safety profile and protection against ototoxicity we have observed in the trial as of the interim analysis. These promising data support continued development of DB-020 to prevent or minimize cisplatin-induced hearing loss, an irreversible condition for which there are currently no available treatments.”

— John Lee, Chief Development Officer of Decibel

“Cisplatin remains an important chemotherapy for the treatment of multiple cancer types, both as a single agent and in combination therapy, and is used routinely in my patients. Administration of DB-020 was generally well tolerated, and did not appear to alter systemic cisplatin levels, reducing concern of impacting the chemotherapeutic benefits of cisplatin on cancer management.”

— Dr. Danny Rischin, Director of the Division of Cancer Medicine and Head of the Department of Medical Oncology at Peter MacCallum Cancer Centre, Melbourne, Australia

“Decibel’s trial underscores the magnitude of hearing loss experienced by cisplatin-naïve cancer patients receiving cisplatin chemotherapy even after a single cycle of cisplatin. Decibel’s interim analysis provides evidence that DB-020 has exciting potential to prevent cisplatin-induced hearing loss and we look forward to continuing to evaluate the effectiveness of DB-020.”

— Dr. Ben Panizza, Director of the Queensland Head and Neck Cancer Centre, Brisbane, Australia

“We believe these positive data showcase the integrated capabilities that Decibel has implemented to develop innovative therapeutics for conditions of the inner ear. We look forward to reporting additional data from the interim analysis of our ongoing clinical trial of DB-020 at an upcoming medical conference, as we continue to advance our broader pipeline, focused on creating a world of connection for people with hearing and balance disorders.”

— Laurence Reid, Ph.D., Chief Executive Officer of Decibel

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