Researchers at Tel Aviv University have reported encouraging new evidence that an experimental medicine called Davunetide may slow the progression of progressive supranuclear palsy, or PSP, in women.
The findings suggest that men and women with the same brain disease may not always respond to treatment in the same way.
The research was published in Molecular Psychiatry and highlights the growing importance of personalized medicine.
PSP is a rare but very serious brain disease that gradually damages areas of the brain responsible for movement, balance, speech, swallowing, and thinking. It is caused by the build-up of an abnormal protein called tau.
As the disease progresses, people often experience frequent falls, trouble moving their eyes, muscle stiffness, and increasing difficulty carrying out everyday activities. There is currently no approved medicine that can stop or slow the disease.
The researchers re-examined data from an earlier 52-week international clinical trial involving more than 300 people with PSP. The original study concluded that Davunetide was safe but did not provide meaningful benefits.
However, medical research has advanced since then, and the team decided to analyse the data again using newer assessment methods now recommended by the U.S. Food and Drug Administration.
Instead of combining all patients into one group, the scientists analysed women and men separately. This produced a very different result. Women who received Davunetide showed much slower disease progression, while men did not appear to benefit in the same way.
The women receiving the medicine maintained important physical abilities for longer. They showed better balance, improved hand movements, and greater independence with everyday tasks such as washing, dressing, and eating. They also performed better on tests of memory, language, and overall thinking ability compared with women who did not receive the treatment.
The team also investigated biological differences between the sexes. They measured abnormal tau protein in the fluid surrounding the brain and spinal cord.
Surprisingly, the relationship between tau levels and disease symptoms differed greatly between women and men, suggesting that the disease may develop through partly different biological pathways.
According to Professor Illana Gozes, these findings demonstrate that separating men and women in clinical research is far more than a statistical exercise. It may reveal treatments that could otherwise appear ineffective when everyone is analysed together. This approach could improve the search for new medicines for several brain diseases linked to tau protein, including Alzheimer’s disease.
The researchers believe future clinical trials should be designed from the beginning to evaluate treatments separately in women and men. This may help identify which patients are most likely to benefit while avoiding unnecessary treatments for those who may not respond. Larger studies will still be needed before Davunetide can become a routine treatment.
The study was supported by ExoNavis Therapeutics, and the results were independently checked by additional statisticians to confirm the analysis. Although conflicts of interest were disclosed, the independent review strengthens confidence in the findings.
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Source: Tel Aviv University.
