Tiny biotech hammered as lead drug fails a key PhII study
Sensorion saw its shares collapse on Monday when the tiny French biotech reported that its only clinical-stage drug had failed the primary endpoint on a key Phase II study — its most advanced test for the therapy.
Founded with an eye to developing new drugs for hearing loss, Sensorion says SENS-401 (arazasetron) failed to reach statistical significance for improving hearing loss compared to placebo in the 115-patient study.
Its shares $ALSEN lost more than 40% of their value after the news hit.
The biotech, though, is searching for some silver linings to hang on to. First, it pointed to a subgroup analysis — always a shaky proposition — illustrating a “better response” for the most severely affected patients with noise-induced hearing loss. And researchers are still studying the data on secondary endpoints, as well as more mature data, to see what else can be teased out of the results.
Sensorion has two other early-stage studies for the drug underway now, with the rest in preclinical development.
“We’re naturally disappointed that the Phase 2 AUDIBLE-S trial of SENS-401 did not meet the primary endpoint of the study. However, we are looking forward to reviewing the secondary endpoints once these become available by mid-March,” CEO Nawal Ouzren said in a prepared statement.
