Allon Therapeutics, Inc. announced that its pivotal clinical trial evaluating its lead product candidate davunetide as a treatment for progressive supranuclear palsy (PSP) failed to demonstrate efficacy in this population. The study had co-primary outcome measures: the Progressive Supranuclear Palsy Rating Scale, and the Schwab and England Activities of Daily Living. Data analysis failed to detect an effect on either the PSPRS or the SEADL. The study also examined a series of secondary and exploratory endpoints. There was no evidence of a drug effect on these secondary or exploratory endpoints in the pre-specified analysis. The company will undertake further analysis to determine if there is any evidence of an effect or explanation for the absence of an effect. Allon said the multinational phase 2/3 randomized, double-blind, placebo-controlled trial enrolled a total of 313 subjects definitively diagnosed with PSP. Subjects were randomized into two groups, and treated with 30 mg of davunetide or placebo twice per day for 52 weeks. The study was carried out under a Special Protocol Assessment with the United States Food and Drug Administration (FDA) at 47 sites in the United States, Canada, United Kingdom, France, Germany, and Australia. The study was designed to enroll a homogeneous PSP population and data generated by the study confirm this finding.

The company will also take immediate action to reduce its ongoing operating expenses including a reduction in staff.