"In women, the experimental drug delayed the deterioration significantly, protected the brain and even reduced symptoms of depression, all in accordance with the mechanism of action," says Prof. Ilana Gozes, who headed the study
The results of a new study at Tel Aviv University reveal that there are significant differences between women and men in response to an experimental drug for neurodegenerative diseases such as Alzheimer's. According to the research team, this is a new opportunity for the research world to emphasize the complex process of drug development, and to treat men and women who will take them differently.
Women VS Men
The research was led by Prof. Ilana Gozes from the department of human molecular genetics and biochemistry in medical school and the Segol School of Neuroscience at Tel Aviv University, in collaboration with students Alexandra Lubinseva and Jason Blatt. The article was published in the prestigious journal Translational Psychiatry from Nature.
Neurodegenerative diseases are characterized by a pathological accumulation of the tau protein (taupathi), in the nerve cells in the brain. The experimental drug that was tested, Davunetide, is based on a segment of the ADNP protein essential for the creation and functioning of the brain, which was discovered in the laboratory of Prof. Ilana Gouzes at the Faculty of Medicine. The effectiveness of the experimental drug that protects against tauopathy in model systems has been tested to date in a series of experiments for a variety of diseases - from Alzheimer's to autism. In the current study, a data analysis of clinical trial findings from the past was performed - with a separation between men and women. The results indicate a significant difference between the sexes in the effect of the drug.
"During the studies we conducted in recent years, I noticed significant differences between the results for males versus females, both in laboratory animals and in humans," says Prof. Gouzes. "That's why I decided to look at the two sexes separately. The first study in which the results were separated between men and women focused on the neurodegenerative disease PSP (Progressive Supranuclear Palsy). In this disease, the leading pathology is tauopathy. In a data analysis carried out about a year ago, we found that the condition of women in the control group (placebo) deteriorated faster Compared to men in this group, however, in women, the experimental drug delayed the deterioration significantly, protecting the brain and nose reduced depressive symptoms, all in accordance with the mechanism of action. In the current study, we performed a separate data analysis in women and men of findings previously obtained from a clinical trial in elderly people with mild memory disorders, which indicate a risk of Alzheimer's disease, which is the most common pathology."
The experiment examined visual and verbal short-term memory abilities among 144 adult subjects, 76 women and 68 men. For three months, the participants were treated every day with a nasal spray of the experimental drug Davantide, and their abilities were tested throughout the period and also one month after stopping the administration of the drug. In the recent separate statistical analysis, a high efficiency was found in improving visual memory in men - an average improvement of 20% compared to the function at the beginning of the treatment, and an improvement of 80% at a 6 times higher dose which indicates a dose-dependent activity and strengthens the findings. In women, due to the administration of the drug in the high dose, an average improvement of approximately 10% in verbal attention memory was found, as well as a decrease in anxiety, compared to a slight decrease in verbal memory in women who received a placebo.
"Our findings indicate that in the complex process of drug development it is important to treat men and women separately - in diseases in general and diseases of the brain in particular. We will continue to develop the drug Daventide and its effectiveness for different populations and a variety of diseases (including a developmental/degenerative brain disease such as ADNP syndrome (where we found tauopathy in age young), while paying attention to the difference between the sexes", concludes Prof. Gouzes.
Dr. Ronan Kreizman, CEO of Ramot adds: "The results of this study open a window to a new period in drug development, a period in which gender is a key variable in the planning of clinical trials and in the development of the drugs themselves. At Ramat, we are proud to support groundbreaking research such as this, which expands the boundaries of medicine and enables the development of innovative treatments for serious diseases. Our investment in this research reflects our commitment to advancing groundbreaking science and research, and bringing innovative medicines to patients who need them."
