science
Reanalysis of Failed 2014 Trial Finds Possible Benefit of Davunetide in Women but Not Men
Scientists found that an intranasal drug previously deemed ineffective may slow disease progression in women with progressive supranuclear palsy. The findings, tied to fluctuating oestrogen levels, prompted plans for sex-stratified trials by ExoNavis Therapeutics.
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A reanalysis of earlier trial data indicates that the experimental intranasal drug davunetide may slow disease progression in women with progressive supranuclear palsy while showing little effect in men. @NewScientist reported that researchers separated results by sex after an initial 2014 late-stage trial found no overall benefit.
Illana Gozes at Tel Aviv University derived davunetide more than 20 years ago from activity-dependent neuroprotective protein.
Allon Therapeutics halted development after the 2014 trial showed no effect on the tau-related condition. Gozes and colleagues then examined prior studies and found that women experienced slower progression and reduced difficulty with swallowing and speaking.
In follow-up experiments, fluorescently labelled davunetide reached the heads of female mice in greater amounts when oestrogen levels peaked.
Eight adult volunteers, six women and two men, received the drug in a pharmacokinetic study, with women showing higher peak plasma concentrations. Davunetide is now licensed to ExoNavis Therapeutics in Tel Aviv, where Gozes serves as vice president of drug development. The company plans sex-stratified clinical trials in ADNP syndrome and progressive supranuclear palsy.
The study appeared in Genomic Psychiatry. Jens Pahnke at the University of Oslo, who was not involved, noted that the mouse and small human data support hypotheses but require caution. He previously observed stronger effects of fingolimod in female mouse models of Huntington’s disease.
