Germany: ME/CFS Research Foundation

Molecular dissection of cell death-mediated inflammation as a driver of virus-induced ME/CFS
The aim is to characterise the causal links between virus-induced cell death, chronic inflammation, and disease-specific symptoms.
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Myoflame-19 Autoimmune Substudy: GPCR Autoantibodies as Mechanistic Biomarkers of Endothelial Dysfunction in Post-COVID ME/CFS
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I think I've seen both the evidence for "chronic inflammation" and "endothelial dysfunction" questioned on this forum. I'm not in a place to comment on that but wanted to mention.
 
OrganicChilli said:
More details for each project: https://mecfs-research.org/en/news-researchfunding-projects2026/

AI summary:
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This is exciting. Whole genome sequencing on multicase families. Hopefully 50 families is enough to find some genes.
2. Genetic Determinants of Post-Infectious ME/CFS: a 50-Family Study

Principal investigator: Prof. Dr. Nataliya Di Donato

Project location: Hannover Medical School (MHH)

Research area: Disease mechanisms

Summary: The project looks into families in which several members have been diagnosed with ME/CFS, aiming to identify genetic risk factors for ME/CFS. Identified families will undergo medical examinations, with their genetic information being analysed using state-of-the-art methods. The project aims to provide a better understanding of the biological causes of ME/CFS and to lay the foundations for improved diagnostics, biomarkers and targeted treatment.

More details about the project:

This project addresses an important gap in ME/CFS research by focusing on families in which several members are affected. Such familial clustering suggests that inherited genetic factors may contribute to disease susceptibility. The project will establish a deeply characterised cohort of 50 families with at least two affected members. Participants will undergo standardised clinical, neurological, and neuropsychological assessments, and severely affected individuals will be included through home visits. Blood samples will undergo state-of-the-art long-read whole-genome sequencing (WGS) to identify complex genetic variation, structural variants, repeat expansions, and DNA methylation patterns that may contribute to disease susceptibility. Additional biospecimens will be stored in the Hannover Unified Biobank to enable future studies of immune function and other molecular mechanisms. By combining comprehensive clinical phenotyping with advanced genomic technologies, the project aims to identify genetic susceptibility factors for post-infectious ME/CFS, improve disease stratification, and establish a sustainable resource for future research. Ultimately, the findings are expected to support the development of improved biomarkers, more precise diagnostics, and targeted therapeutic strategies.
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OrganicChilli said:
More details for each project: https://mecfs-research.org/en/news-researchfunding-projects2026/
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1. TAME – CD19-targeted B-cell therapy for post-infectious autoimmune ME/CFS using the monoclonal antibody tafasitamab: open-label follow-up study to a randomized, placebo-controlled Phase II trial of the CD19 antibody inebilizumab

Principal investigators: Prof. Dr. Carmen Scheibenbogen & Dr. Judith Bellmann-Strobl

Project location: Charité – Universitätsmedizin Berlin
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Tafasitamab is being administered as a direct follow-up treatment in a study succeeding the PIONEER trial (funded by the Federal Ministry for Research, Technology and Space, BMFTR), in which the CD19 antibody inebilizumab was used. The aim is to determine whether tafasitamab can achieve or maintain B-cell depletion and clinical remission as effectively as inebilizumab.
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It's a follow-up to a trial of inebilizumab to see if tafasitimab is as effective for clinical remission. Does anyone know where the results for that placebo controlled trial are? We have very few mentions of the drug on the forum.
 
forestglip said:
It's a follow-up to a trial of inebilizumab to see if tafasitimab is as effective for clinical remission. Does anyone know where the results for that placebo controlled trial are?
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Slide 11 of the presentation in the link for PIONEER says the study was "in vorbereitung" (in preparation) at that time. On the other hand, they write "The TAME study will involve 38 patients who previously participated in the PIONEER trial". Participated, past tense.
 
Judith Bellmann-Strobl talked about their work with inebilizumab at the 2026 International ME/CFS Conference (YouTube). As @Timko says, the PIONEER study is planned for later this year.

She talks about a few cases that improved from the drug (starting around 3:10). I don't think that was from a placebo-controlled trial. That may be what the above study description means when it says "achieve or maintain B-cell depletion and clinical remission as effectively as inebilizumab."
 
ME/CFS Science Blog said:
I don't fully understand, though, because it is quite likely that inebilizumab will turn out to be ineffective. So then this follow-up study with tafasitimab would no longer be indicated?
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I don’t fully understand either but as the projects from the ME/CFS Research Foundation have to start and finish quite early, it could be that they will give Tafasitamab before they unblind the Inebilizumab study? Just a guess though.

I feel like they are quite sure that it will work, Prof Scheibenbogen also said at the Conference that subgroup analysis of the placebo controlled immunoadsorption trial revealed that there was a subgroup who responded if I remember correctly. (in the german talk about therapies at the german symposium). So I guess they believe that the neurologists at charité „fucked up“ their immunoadsorption trial and now they want to prove that B Cell depletion works. They (Scheibenbogen and Bellmann Strobl, not zhe neurologists from the immunoadsorption study) are in charge for the 2 new studies too now. I guess we will have to see…
 
justlxsa said:
I feel like they are quite sure that it will work, Prof Scheibenbogen also said at the Conference that subgroup analysis of the placebo controlled immunoadsorption trial revealed that there was a subgroup who responded if I remember correctly. (in the german talk about therapies at the german symposium).
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Thanks. I suspect they are a bit too confident about this.

The only way to be sure that there's a subgroup that responds is to do a new randomized trial in this subgroup only and compare the treatment versus a placebo.

What they seem to be doing is, after a trial finished and produced null results, to look if there is a subgroup of patients on the treatment that got a better response. This is a post-hoc analysis and not reliable evidence IMHO. Only good to get hypotheses for further studies.
 
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ME/CFS Science Blog said:
Thanks. I suspect they are a bit too confident about this.

The only way to be sure that there's a subgroup that responds is to to a new randomized trial in this subgroup only and compare the treatment versus a placebo.

What they seem to be doing is, after a trial finished and produced null results, to look if there is a subgroup of patients on the treatment that got a better response. This is a post-hoc analysis and not reliable evidence IMHO. Only good to get hypotheses for further studies.
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It’s a circular argument: The people that had better scores are the ones that had better scores.
 
From Twitter.

Machine Translation:
ME/CFS Research Foundation
@MECFSResearch
Jul 31

We need your support—will you join us?

We're looking for volunteers to support the community management of our social media channels. Together with our Social Media Team, you'll respond to comments from our community.

Interested? Apply now: ehrenamt@mecfs-research.org
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German original:
ME/CFS Research Foundation
Jul 31
Wir brauchen Verstärkung – bist du dabei? Wir suchen ehrenamtliche Unterstützung für das Community Management unserer Social-Media-Kanäle. Du beantwortest gemeinsam mit unserem Social Team Kommentare aus der Community. Interesse? Jetzt bewerben: ehrenamt@mecfs-research.org
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mecfs-research.org

Die Top 100 Therapiestudien zu PAIS: Entsteht der nächste Blockbuster-Markt? - ME/CFS Research Foundation

Der Gastautor, Dr. Fred Dejonckheere, ist Arzt und Experte für Gesundheitsversorgungsstrategie, Medikamenten-Entwicklung und -Marktzugang mit Sitz in Basel, Schweiz, und arbeitet in der pharmazeutischen Industrie. Der vorliegende Beitrag mit einer Übersicht klinischer Studien zur...
mecfs-research.org mecfs-research.org

This 2500-word article is featured prominently in their latest newsletter:

The Top 100 Interventional Trials in PAIS: Is the Next Blockbuster Market Taking Shape?​

August 14, 2026
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The guest editor, Dr. Fred Dejonckheere, is a physician and healthcare strategy and leadership professional with expertise in pipeline development and market access, based in Basel, Switzerland, and works in the pharmaceutical industry.
This overview article on trials developing treatments for post-acute infection syndromes (PAIS) was created in his role as a doctor and carer.
The views expressed in this guest article represent solely the personal opinions of the author.
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The original article was posted by Dr. Dejonckheere on 9 January 2026 on LinkedIn (external link). This article contains an updated version of the Top 100 list compared with the original, along with adjustments to the text and a German translation.
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Conclusion: the blockbuster opportunity is now​

While current blockbuster markets offer volume, they face inevitable commoditisation and intense competition.
In contrast, the PAIS landscape—spanning Long COVID, ME/CFS, POTS, Fibromyalgia and Lyme—offers the rare chance to build a durable, high-margin, category-defining franchise.

The emerging scientific consensus, validated by the rapid expansion of the clinical pipeline, confirms the existence of multiple novel and actionable targets.
Therapeutic approaches targeting B-cells, metabolic correction, and viral persistence represent more than incremental innovation; these are high-conviction bets on a fundamental immune system reset for millions of patients.

For major pharmaceutical players with established immunology, cardio-vascular and neurology portfolios, expanding into PAIS is a seamless strategic evolution, leveraging existing expertise in inflammation, fibrosis, coagulation and immune modulation.

The first regulatory approval of a novel, mechanism-based therapy will act as a singular inflexion point, triggering a multi-billion-dollar market unlock and validating this high-unmet-need asset class.
Beyond commercial validation, such a milestone will finally confront a global economic burden now exceeding 1 trillion USD annually.
With a record number of specialised biotechs fueling a rapidly maturing clinical pipeline and big pharma definitively pivoting into late-stage PAIS portfolios, we are likely standing at the threshold of a breakthrough many have underestimated.

For leaders bold enough to look beyond current blockbuster markets, and invest in validating core PAIS mechanisms, the prize is likely to be generational leadership.
The goal is not just to participate, but to deliver the “Humira” (Autoimmunity), the “Keytruda” (Oncology), the “Ocrevus” (MS), or the “Ozempic” (Metabolic) of post-acute infection syndromes.
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The emerging scientific consensus, validated by the rapid expansion of the clinical pipeline, confirms the existence of multiple novel and actionable targets. Therapeutic approaches targeting B-cells, metabolic correction, and viral persistence represent more than incremental innovation; these are high-conviction bets on a fundamental immune system reset for millions of patients.

For major pharmaceutical players with established immunology, cardio-vascular and neurology portfolios, expanding into PAIS is a seamless strategic evolution, leveraging existing expertise in inflammation, fibrosis, coagulation and immune modulation.

Sorry to say that I do not think science works like this. It works in a much more mundane way, picking through evidence, being sceptical, using common sense and noticing when something suddenly tells you what you have been missing. Nothing to do with leverages or portfolios. We never talked of those in the golden age of biomedicine!

The examples look like flogged horses no betting men should touch. They may yet prove relevant but the emerging scientific consensus, like the law of headlines with a question mark, usually deserves a 'no'.

And we are not here to swell the wallets of the investors. We are here to make people's lives liveable.
 
Chandelier said:
mecfs-research.org

Die Top 100 Therapiestudien zu PAIS: Entsteht der nächste Blockbuster-Markt? - ME/CFS Research Foundation

Der Gastautor, Dr. Fred Dejonckheere, ist Arzt und Experte für Gesundheitsversorgungsstrategie, Medikamenten-Entwicklung und -Marktzugang mit Sitz in Basel, Schweiz, und arbeitet in der pharmazeutischen Industrie. Der vorliegende Beitrag mit einer Übersicht klinischer Studien zur...
mecfs-research.org mecfs-research.org

This 2500-word article is featured prominently in their latest newsletter:
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Thread for this article previously posted on LinkedIn: https://s4me.info/threads/opinion-t...-market-taking-shape-fred-dejonckheere.48322/
 
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