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Hearing drug failure puts biotech on brink


Date: 2018-03-27

News Type: Expo News


Biotechs with few products in the portfolio are always at a risk should results come back flat, it often leads to them taking negative results and finding a way to examine the data to find a new angle to take the drug back into the clinic.


This was the case with Auris Medical, with it hoping that it could be a case of second time lucky when it sent its tinnitus drug back into Phase 3 trials, despite a previous failure.


However, the drug, Keyzilen, flopped, again. The outcome of the trial leaves the tiny biotech in a precarious position, it only has one other drug candidate in its portfolio – a treatment for vertigo.


The biotech is staying coy on what its plan is for Keyzilen now, but it seems unlikely that it will take another risk by putting the drug back into Phase 3 trials.


In a short statement on the failure, the biotech stated: “Preliminary top-line data from the TACTT3 trial indicate that the study did not meet its primary efficacy endpoint of a statistically significant improvement in the Tinnitus Functional Score from baseline to Day 84 in the active treated group compared to placebo either in the overall population or in the otitis media subpopulation. The Company is investigating the outcomes, including those in the previously conducted sister trial TACTT2, and will provide an update in due course.”


The failure comes even after the biotech had made changes to the original trial design to increase enrolment and focusing on improvement on the Tinnitus Functional Index score.


The company does have another candidate in its portfolio, AM-111, but even that treatment, for hearing loss, struggled in a Phase 3 trial; it was revealed that this treatment, as well, had failed to meet its primary endpoints but the biotech pointed out a sub-group that had performed well under the treatment as a potential sign for hope. It remains to be seen whether the biotech will have enough in the bank to follow through on that potential.


- Pharma File Ben Hargreaves -






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