Still in preclinical testing for ear gene therapies, Decibel touts small snapshot of chemo-induced hearing loss drug
Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.
Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.
The biotech had 17 evaluable patients as of the Feb. 4 cutoff date who had never before received cisplatin. Following the most recent chemo cycle, 15 of the 17 patients experienced on average a 30 decibel-loss from baseline in the placebo ear. Of those 15, eight patients did not lose their hearing in the DB-020-treated ear, and another five were partially protected from hearing loss.
All ears treated with DB-020 lost approximately eight decibels on average from baseline, Decibel said.
DB-020 is a formulation of sodium thiosulfate injected through the eardrum before patients receive cisplatin-based chemotherapy. The procedure can be done in an ENT’s office without the need for invasive methods, the company touts.
A Phase Ia study in healthy volunteers had been completed in 2019 and the company subsequently moved forward with the Phase Ib trial. The results had been delayed due to the Covid-19 pandemic, Decibel said in a press release early last year. After kicking off the Phase Ib trial in February 2020, the company anticipated collecting final primary outcome measures in April 2021 and completing the study that October. The biotech revised those timelines during the pandemic, with the target dates now December 2022 and December 2023, according to changes to the trial’s registry on clinicaltrials.gov.
Decibel’s gene therapy programs still remain in the preclinical phase, but the company is hoping to have an IND for its first such candidate submitted by the end of the year. The focus on gene therapies for regeneration and balance came after a pivot away from ear-related conditions such as tinnitus and hearing loss a few years ago. Decibel is partnered with Regeneron on some of the programs, and secured an extension to its research collaboration with the biopharma last November.
The shift was enough to garner a Series D in November 2020 and a quick jump to Nasdaq a few months later. Like many companies, Decibel has seen its stock price $DBTX sink in this year’s bear market, as it’s down 55% since the start of the year as of Monday’s close.