Welcome
Dear Friends and Colleagues,
EPAD had a fantastic summer, the cohort study reached a major milestone recruiting its 1,000th Research Participant on World Alzheimer Day and at present is over 1,100 Research Participants strong. For those of you who would like to follow recruitment more closely, EPAD’s WP3 has developed a great tool to do so: SEEPAD, check it out here. In addition, the EPAD Academy initiated its first exchange program and we saw the release of the first EPAD data set v500.0 which were presented at CTAD. Overall the EPAD scientific community has been very active of late, with 1 presentation and 2 posters at the IMI 10th Anniversary Scientific Symposium, 1 presentation and 5 posters at CTAD, and 2 presentations at the 28th Alzheimer Europe conference.
Unfortunately, it is not all good news for the Alzheimer field. At the start of the CTAD conference disappointing results were shared from several Phase 3 and one Phase 2 clinical study with beta-secretase (BACE) inhibitors that were in development for the treatment of Alzheimer’s disease (AD) targeting a broad spectrum of the AD population ranging from people with preclinical AD, to mild cognitive impairment (MCI) and mild-to-moderate dementia. We already knew that development of Merck’s verubecestat, Eli Lilly’s LY3202626 and Janssen’s atabecestat were stopped, the first two for lack of efficacy, atabecestat because of its unfavorable benefit-risk profile (i.e. increase in liver enzymes). At CTAD additional results were presented that indicated treatment with these compounds might also have resulted in worsening on cognitive measures. You can learn more in the following CTAD press release “IS THERE A ROLE FOR BACE INHIBITION IN ALZHEIMER’S TREATMENT?” Although it is still too early to conclude whether these effects are specific to these BACE inhibitors or involve the entire class, one thing is clear and that is that these results point to the need for clinical trial platforms such as EPAD. Both in the verubecestat and atabecestat studies the decline in cognitive function became apparent already after 3-6 months of treatment. However, because of the design of these studies this decline went undetected until the data were analyzed once the studies were stopped. In EPAD, because all data -including the cognitive data- are analyzed and reviewed every three months such an effect would have been noticed much earlier. Furthermore, these results once more emphasize the need for doing proof-of-concept studies before entering large scale Phase 3 studies involving many patients.
Many companies start realizing this, which also shows in EPAD’s well-stocked virtual pipeline. The negotiations with the first intervention owner are progressing well and we are hopeful that we will be able to start the first PoC appendix in the summer of 2019 (more news to follow soon). In addition, the clinical candidate selection committee has two more interventions lined up with a scheduled start late 2019 to early 2020 and is already discussing with other potential intervention owners whose compounds are not yet PoC ready but will be in 2021 or 2022.
To close I would already like to draw your attention to the EPAD General Assembly which will be organized and hosted by Prof. Frisoni and his team in Geneva from May 15-17. If you have not done so already, I suggest you already block you calendars so you do not miss out on the must attend EPAD event of the year.
So far 2018 has been a great year for EPAD, and thanks to your continued dedication and ceaseless efforts 2019 has the potential to be even better. I realize I have said it before, but in my view, it cannot be repeated enough, thank you for all you have done and continue to do for EPAD as we prepare to start the PoC in 2019.
This electronic newsletter will be published quarterly and be accessible via the EPAD website (https://alzheimer.noemi.lu/) and inform the Alzheimer’s community on EPAD’s main achievements, upcoming events as well as allow you to meet the scientists who make it all happen.
We hope you enjoy this issue of the EPAD newsletter! Happy Reading!
Serge Van der Geyten
EPAD Coordinator
