Decibel Therapeutics Delivers Solid Interim Data From Cisplatin-Associated Hearing Loss Study

Decibel Therapeutics Inc DBTX reported positive top-line results from an interim analysis of its ongoing Phase 1b clinical trial of DB-020 to protect against hearing loss in cancer patients receiving cisplatin chemotherapy. 

The interim analysis showed that 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.

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

Related: Decibel Therapeutics Shares Encouraging Preclinical Data From Hearing Loss Gene Therapy Programs.

DB-020, administered before cisplatin, had no apparent effect on systemic cisplatin levels.

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

DB-020 reduced cisplatin-induced loss of speech audibility by 80%.

HC Wainwright writes that at least one additional clinical trial (possibly registrational) is expected to be required to bring DB-020 closer to approval, the analyst notes.

In addition, the company expects that a set of preclinical studies may be needed to explore different cisplatin regimens to design a larger study in patients. 

Based on its delineating efficacy profile DB-020 could target a population of 270,000 patients/year in the U.S., E.U., and Japan with a launch in 2026 and projected peak sales of $1.8 billion on a 25% penetration.

Price Action: DBTX shares are up 21.60% at $2.73 during the market session on the last check Tuesday.