NEWSLETTER, ISSUE 4
4 December 2023
Dear colleagues, partners, investigators and patients,
With this newsletter we present to you the 4th update of the NGID project and the final update of 2023.
We are looking back at eventful first months with a successful project launch, the first achieved milestones and the initiation of the different workpackages. Good news also from our legal department, we managed to sign off the Consortium Agreement and we do have full green light from NWO for project execution. The first NGID employees have already started.
In addition, we look forward to 2024 with major events and milestones including launch of the website, hiring of many new NGID members and our annual meeting on Friday, 21st June 2024 – save the date and join us for an exciting day of skin science.
Finally, we proudly present the first scientific NGID publication of the SKINERGY psoriasis trial. We performed for a first time a randomized, placebo-controlled trial with guselkumab and demonstrated a long-lasting remission and high benefit for mild patients with psoriasis. We are happy that these results are appreciated in the field as it was published in the #1 journal in Dermatology #JAAD.
We wish you a well-deserved relaxing break and Merry Christmas to all of you.
The NGID Supervisory Team
Table of Contents
- MILESTONE HIGHLIGHT: First scientific publication of our consortium
- ANNOUNCEMENTS
- UPDATE WP2.2 Clinical trials
MILESTONE HIGHLIGHT: First scientific publication of our consortium
With great pleasure we are presenting our first scientific NGID publication in the Journal of the American Academy of Dermatology #JAAD – the number #1 Dermatology journal.
Summary
We have conducted a randomized, controlled trial SKINGERGY PSORIASIS in which 20 mild psoriasis patients were randomized to placebo or guselkumab, an interleukin-23 antagonist. Realizing the novelty of anti-IL-23 therapy in mild patients and the potential for long-term disease modification in this patient group, we have assessed its efficacy in a 12-week treatment period and continued to follow up the patients until relapse. Our results show that biologic therapy in mild patients is efficacious and safe and this aligns with previous results of anti-IL-17 therapy in mild cases of psoriasis. Moreover, we demonstrated longer lasting remission of this biologic therapy, however, complete disease modification was not observed. This was the first publication of an indepth series about the SKINERGY PSORIASIS trial, one of the exploratory trials of WP 2.2. Three more publications are planned around this trial about imaging, biomarkers and the various omics techniques. Stay tune or even better: get involved.
Congratulations to all authors at LUMC, Erasmus MC, Radboud UMC, Leiden University and CHDR!
Publication link: https://www.jaad.org/article/S0190-9622(23)02896-7/fulltext
MISSED THE KICK-OFF CELEBRATION?
To brighten up your dark winter days, have (another) look at our beautiful summer kick off at Leiden Boerhaave Museum on July 7th.
Efficacy of guselkumab in patients with mild psoriasis compared to placebo. Efficacy is expressed as mean absolute Psoriasis Area and Severity Index (PASI) over time for patients randomized to guselkumab (n = 15) or placebo (n = 5). Patients were administered guselkumab 100 mg or placebo at day 0 (dose #1), week 4 (dose #2), and week 12 (dose #3).
ANNOUNCEMENTS
Agreement(s) [WP management]
Great news about the consortium agreement, we managed to fully sign off the CA in due time. We did perform several review cycles and beginning of September there was general concensus. After administrative intake and check by NWO – we now have a fully executed version that is fully effective and greenlighted. Currently, we started to draft a 2nd version of the CA with mainly administrative changes.
Due to the high number of partners the Supervisory Team decided to have separate collaboration agreements with a couple of partners, for instance all patient organisations, all service (tech) providers, all subcontractors etc. Next to the collaboration agreement these partners remain represented in the approved grant application and are integral part of the consortium. These collaboration agreements will be finalized in the upcoming months. Thank you all for your collaborative spirit and smooth turn around of the agreements.
For the SKINERGY trial we are drafting separate Clinical Trial Agreements. The first draft is currently being reviewed by Utrecht UMC and University of Maastricht.
Consortium composition [WP management]
Prior to the summer one of our consortium technology members informed us of leaving the consortium. This had to do with strategic reasons and unfortunately RiverDiagnostics is no longer part of NGID. Due to their exit and the missing in kind contribution of RiverD, the budget needed to be revised. On the other hand, the Supervisory Team is currently talking to several pharmaceutical companies to become additional partner of NGID via the accession procedure. Of note, NWO already approved the new composition as well as the revised budget. In conclusion, in such a large consortium it seems normal to have some degree of dynamic changes of exiting and/or new partners.
HR [all WPs]
Since 1st July 2023 we can officially hire staff as allocated in the budget. Do you want to hire on an allocated position? Please inform your WPL since we need to track and report all employees to NWO. We also welcome the new staff members to the NGID team – we are happy to have you onboard!
TIMELINES
Finances
University Maastricht has calculated a new final budget and provided to the Supervisory Team and Management team. Meanwhile, also NOW has approved this budget. We will now send around a “per institution” budget for each partner (as per the budget of the award letter).
NWO news
As stated above we are smoothly cooperating with NWO in the startup phase. The amendments of the projects entail: a new consortium composition (RiverD left), budget revision (less in kind contribution), starting date officially set to 1 JUL 2023, CA final check. All amendments were approved and also a new award letter with the budget change was provided. The award letter will be send to all partners by e-mail separately. NWO also suggested to perform a (virtual) user committee meeting for a general introduction (March/April).
UPDATE WP2.2 Clinical trials
The exploratory SKINERGY trials are progressing well:
The clinical phase of SKINERGY CTCL has finished and the clinical database has been locked. Some bioanalysis has been started, e.g. microbiome and biopsies. Results are expected mid 2024.
SKINERGY psoriasis has finished clinical phase, database is locked and bio-analysis is pending. Full data set is expected in 2024 – publications writing.
SKINERGY CLE has been approved by EC. Patients are pre-screened at LUMC and Erasmus MC and enrollment of patients starts in January 2024. PATIENT LINK
SKINERGY CSU has been approved by EC. Clinical trial agreement pending and start of execution in February / March 2024.
SKINERGY basket trial design has been drafted and is in discussion with patients (31 January) and investigators, i.e. disease specialists. Submission to CTA is expected in March 2024 with central and local EC approval in June 2024.
Scientific Advisor Board
The scientific value of NGID is of uttermost importance for the project. Therefore, it is with great pleasure that we can announce that we were able to compose a diverse and very knowledgable SAB for their input into our project.
| Name | Focus area |
| Prof.Maurice van Steensel | clinical, molecular genetics, dermatology |
| Prof. Sandrine Dubrac | biology, barrier, atopic dermatitis, dermatology |
| Prof. Martina Marchetti-Deschmann | technology, mass spectromety imaging |
| Prof. Stephan Weidinger | clinical/consortia, infllammation, dermatology |
| Prof. Yang Li | data integration, bio-informatics |
| Prof. Marcus Maurer | urticaria, clinical dermatology and allergology |
All SAB members confirmed their participation of our exciting project. A very warm welcome to our SAB members!
