Biohaven to plough on with troriluzole study in Alzheimer's

Connecticut, USA-based neurology specialist Biohaven Pharmaceutical (NYSE: BHVN) saw its shares rise as much as 11.6% pre-market, after it announced successful completion of a pre-planned interim futility analysis for the T2 Protect AD Study. The stock was still up 3.3% at $55.55 mid-morning.

This study is an ongoing Phase II/III clinical trial of troriluzole in Alzheimer's disease led by the Alzheimer's Disease Cooperative Study (ADCS) at the University of California San Diego School of Medicine.

The independent data-monitoring committee (DSMB) communicated that futility was not met based on pre-specified criteria for the interim analysis, which evaluated standard cognitive assessments and hippocampal volume on magnetic resonance imaging parameters. The interim analysis was designed specifically to allow for stopping the trial early due to futility. In order to pass the interim futility analysis, troriluzole had to demonstrate numerically greater benefit over placebo on at least one of the two pre-specified criteria at 26 weeks: either (i) cognitive function as measured by the ADAS-cog or (ii) hippocampal volume as assessed by magnetic resonance imaging. Biohaven announced that based upon the interim futility and safety analysis performed by the independent DMSB that the study would continue.

There are presently no approved treatments to delay the progression of Alzheimer’s disease, though Biogen (Nasdaq: BIIB) yesterday presented some semi-encouraging data for its previously-shelved aducanumab. Analysts are forecasting that the first drugmaker to offer it will rake in billions of dollars.