21 December 2012. The world did not end today as predicted, but unfortunately we have to report that development of another potential drug did. Allon Therapeutics Inc. announced 19 December that its drug candidate davunetide failed to show efficacy for progressive supranuclear palsy (PSP) in a Phase 2/3 trial. Participants showed no benefit on either of the primary outcome measures, the Progressive Supranuclear Palsy Rating Scale and the Schwab and England Activities of Daily Living. The drug did not affect secondary or exploratory endpoints, either, the company reported in a press release. Allon said it does not plan to invest further in davunetide development at this time.
Davunetide, a small peptide derived from a neuronal growth factor, targets tau pathology. It blocks tau hyperphosphorylation in mice and may stabilize microtubules (see ARF related news story; ARF news story; and ARF news story). In addition, it was previously shown to support working memory in people with mild cognitive impairment (see ARF related news story). Company scientists tested the drug in people with PSP because this devastating movement disorder is a pure tauopathy with no effective treatment. The trial ran at 47 sites in six countries, and the 313 participants received either 30 mg of intranasal davunetide or placebo twice daily for one year. The drug appeared safe in this population. The company plans to analyze the data further for clues on why it failed.––Madolyn Bowman Rogers.