If at first you don’t succeed, try a sub-population analysis, the biotech playbook goes. That’s exactly what Sensorion is doing after its phase 2 hearing loss treatment—and lead program—flopped a key study in January.
The French biotech released an update (PDF) Thursday from the midstage study, which tested SENS-401 in patients with sudden sensorineural hearing loss (SSNHL). The trial featured 115 patients and aimed to improve hearing in the affected ear when compared to placebo at the end of the four-week treatment period.
But the drug did not do that, although it was found to be safe. Now, Sensorion says a sub-population analysis has revealed a “statistically significant treatment effect” for certain patients.
The company said a “clinically meaningful” improvement of at least 10 decibels was seen in the high-dose cohort at day 84 in patients who also received corticosteroids. This group made up 70% of the trial population, or 81 people.
In a second analysis, Sensorion found that patients suffering from profound hearing loss who received corticosteroids saw a significant response at day 28 and 84, with a 19- to 26-decibel improvement from the baseline when compared to placebo.
Essentially, if the study had observed patients further out after treatment, Sensorion said, an effect would have been seen.
“We note many patients entering the study with profound hearing loss have emerged with mild hearing loss, meaning they do not have difficulty hearing what is said in quiet environments,” said Sensorion Chief Medical Officer Géraldine Honnet. “This is the first time that this level of improvement has been demonstrated" in SSNHL patients with profound hearing loss, he said.
With the new spin on the study results, Sensorion plans to go hunting for financing for further clinical development of SENS-401 in SSNHL, as well as cisplatin-induced ototoxicity, a type of hearing loss brought on by treatment with cisplatin chemotherapy.
But Sensorion plans to be mindful of its R&D resources given the “challenging capital markets,” as it searches for a way to fund new development of SENS-401. The company will update its plans for the therapy “in due course.”
In the meantime, Sensorion is advancing a trial of SENS-401 along with partner Cochlear Limited to test the med’s ability to preserve hearing in patients who receive a cochlear implant. The study design has been submitted to regulators in Australia and France for consideration.
Beyond SENS-401, Sensorion is working on gene therapies to correct hereditary forms of deafness, although the four assets in the company’s pipeline besides SENS-401 are in the preclinical phase. A clinical trial application for OTOF-GT, a gene therapy for restoring hearing in patients with the common congenital deafness disorder Otoferlin deficiency, is slated for the first half of 2023.