science
Reanalysis finds no overall benefit from intranasal drug in progressive supranuclear palsy trial, possible signal in women
A failed 2014 trial of davunetide showed benefits for women after researchers separated results by sex. Estrogen levels appear to influence how much of the drug reaches the brain in female mice and volunteers.
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A reanalysis of data from a 2014 clinical trial indicates that the experimental intranasal drug davunetide may slow disease progression in women with progressive supranuclear palsy. Researchers led by Illana Gozes at Tel Aviv University separated prior study results by sex and found the drug protected against symptoms such as difficulty swallowing and speaking in female participants.
Davunetide was developed more than 20 years ago by Allon Therapeutics from activity-dependent neuroprotective protein.
The 2014 late-stage trial for progressive supranuclear palsy showed no overall effect, leading the company to halt development. Gozes and colleagues later examined genetic activity in male and female mice with an ADNP mutation and found almost no overlap in altered gene sets between the sexes.
In new experiments, fluorescently labelled davunetide reached the heads of female mice in greater amounts when oestrogen levels were highest.
Eight adult volunteers, six women and two men, received the drug in a pharmacokinetic study; women showed higher peak plasma concentrations than men. Davunetide is now licensed to ExoNavis Therapeutics in Tel Aviv. Gozes, who serves as the company’s VP of drug development, said the firm plans sex-stratified clinical trials in ADNP syndrome and progressive supranuclear palsy.
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