Results

0-for-3 in PhIII: Auris’ late-stage changeup fails to save tinnitus drug from another disaster

Eighteen months after the hapless Swiss biotech Auris Medical $EARS announced its first Phase III study for its experimental drug Keyzilen (AM-101) for tinnitus had flopped, its second late-stage study has also come in snake eyes — even though it revised the endpoints and made the case it had good reason to believe it was on track to win.

Winning, though, is not something this company does much of.

In a barebones statement, the penny stock biotech reported:

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.

Auris CEO Thomas Meyer

Researchers for the company insisted that they found in a subsequent analysis of the first Phase III that the otitis media subgroup of patients demonstrated a statistically significant improvement for the Tinnitus Functional Index (TFI) score. And that’s why they went for the revamp of the second Phase III.

It didn’t help, which is often the case with these 11th hour trial revisions.

In the meantime, Auris announced last fall that its hearing loss drug, AM-111, also failed in its Phase III trial.

The company simultaneously noted today that its stock, which closed at 25 cents a share on Tuesday, was in for a one-for-10 split to keep it in line with Nasdaq rules. Before that, the stock took a 40% hit in after-market trading, falling 10 cents.

Its only other drug in clinical development is AM-125, an intranasal formulation of betahistine for vertigo.


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