Clinical trial: Temelimab as a disease-modifying therapy in patients with neuropsychiatric symptoms in Long COVID (or PASC)

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Braganca

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The GNC-501 study, titled “Temelimab as a Disease Modifying Therapy in Patients with Neurological, Neuropsychological, and Psychiatric Symptoms in Post-COVID-19 or Post-Acute Sequelae of COVID-19 (PASC) Syndrome,” will enroll 200 patients from Swiss and European study centers suffering from severe neuropsychiatric syndromes following COVID infection. In this biomarker-based study, only patients who also test positive for the pathogenic protein W-ENV will be recruited with the aim of reducing their disabling conditions.

https://clinicaltrials.gov/ct2/show/NCT05497089?term=temelimab&draw=2&rank=1
 
https://www.20min.ch/fr/story/la-suisse-teste-un-remede-prometteur-contre-le-covid-long-995453838078

Switzerland is testing a promising remedy for long Covid
Five hospitals are recruiting patients to participate in a clinical trial. Objective: to assess the effectiveness of a treatment developed by a Geneva start-up.

Research to cure the long Covid has taken a new step. Five Swiss hospitals – in Basel, Bern, Sion, Chur and Geneva – are testing a treatment deemed promising. Developed by GeNeuro , a Geneva biopharmaceutical company, the remedy neutralizes a protein activated by the virus. Suspected of playing a major role in persistent inflammation, it is present in one out of four patients.

In order to test the effectiveness of the drug, the establishments are currently looking for volunteers . "We hope to recruit 200 by the end of February," says Professor Idris Guessous, head of the Primary Care Department at Geneva University Hospitals (HUG). For this, they must in particular be carriers of the pathogenic protein W-ENV and have concentration or fatigue problems.

For six months, “half of the participants will be injected with antibodies intended to stop the protein production cycle. The other half will receive the placebo, ”explains the manager. The results are expected at the end of summer 2023. By then, centers in Rome and Barcelona could join the study.

“Hope is great!”
For Jesús Martin-Garcia, general manager of GeNeuro, there is no doubt that the injection of antibodies will have a beneficial effect. The question that remains is, “Will this fix 90% or 40% of the problem? Only clinical trials can tell us. But the hope is great.” In the event of positive results, with the accelerated procedures, the marketing of the remedy could take place at the end of 2023, estimates the chief doctor at the HUG. In order to carry out this research, the Geneva company received financial aid from the Confederation.
 
https://pubmed.ncbi.nlm.nih.gov/32794123/

Temelimab, an IgG4 Anti-Human Endogenous Retrovirus Monoclonal Antibody: An Early Development Safety Review

Abstract

Introduction: Temelimab (formerly called GNbAC1) is an immunoglobulin (Ig) G4 monoclonal antibody that targets the human endogenous retroviral envelope protein HERV-W-Env, shown to be associated with the pathogenesis of certain autoimmune disorders such as multiple sclerosis (MS) and type 1 diabetes mellitus (T1D). By neutralizing HERV-W-Env, temelimab could act as a disease-modifying therapy for these disorders. It is currently in clinical development for MS and T1D.

Methods: The safety information on temelimab (including potential infusion-related reactions, malignancies, pregnancies and antidrug antibodies) collected during three phase I and four phase II clinical trials was reviewed and is summarized in this article.

Results: In the entire development program, 54 healthy volunteers received single doses of temelimab in three phase I studies, and 334 MS or T1D patients received temelimab for a total estimated exposure of 465 patient-years in four phase II trials. No differences were observed between numbers of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) between treatment groups (including placebo), and the number of SAEs was limited. Furthermore, no differences were observed in laboratory evaluations, vital signs, electrocardiogram (ECG), or physical examinations between treatment groups. Rare potential infusion-related reactions were reported. Temelimab treatment was not associated with an increased risk of infections or infestations.

Conclusion: These results suggest that treatment with temelimab was not associated with any particular type of AE. Overall, temelimab was safe and very well tolerated over the tested dose range after repeated monthly administrations.

other studies at link
 
FMMM1 said:
"
Brief Summary:
This study is a Phase 2, 24-week, randomized, prospective, double-blind, multicenter study in patients experiencing neuropsychiatric symptoms and functional impairment in the course of PASC. ---"
Click to expand...

outcome measure for fatigue subjective - questionnaires --- but not as bad as unblinded with questionnaires

"
Primary Outcome Measures :
  1. Composite endpoint: improvement in cognitive impairment or fatigue in PASC patients [ Time Frame: 24 weeks ]
    Occurrence of an improvement in cognitive impairment, measured by an increase of ≥0.5 z-scores in the Token Motor Test, or in fatigue, measured by a decrease of ≥3 points in the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a) score, at Week 24 as compared to baseline.

Secondary Outcome Measures :
  1. Fatigue [ Time Frame: 24 weeks ]
    Change from baseline to Week 24 in the Severity of fatigue as measured by the PROMIS Fatigue SF 7a score
 
If "Human Endogenous Retrovirus Type W" are important then presumably you'd expect a genetic clue in the GWAS study (Chris Ponting)?
 
The research group's pre-clinical and safety study article has more background:

https://www.tandfonline.com/doi/full/10.4161/19420862.2014.985021


Glad the data on adverse events, such as infestations is okay. Are we talking TB or lice, or maybe copy-editing (again). I think the word is "infections."

True malignancy data takes longer than 14 months to generate. If and when the drug is approved, the post approval or Phase IV real world use will reveal the true malignancy data.
 
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GeNeuro Announces Results of the GNC-501 Study in Post-Covid-19 Syndrome

"The GNC-501 clinical trial is a Phase 2 study in patients suffering from post-COVID-19 neuropsychiatric syndromes, testing temelimab against placebo. The study enrolled over 200 patients in Switzerland, Spain and Italy who had tested positive for HERV-W ENV. The top-line results from this study show that treated patients had no clinically meaningful improvement compared to placebo on the primary endpoint measuring the improvement of fatigue with the PROMIS SF7a test. The majority of secondary endpoints did not show an effect either. The treatment was very well tolerated and safe, consistent with previous clinical trials in other indications.

Preliminary analyses suggest that shorter disease duration at time of inclusion, as well as the evolution of the underlying HERV-W ENV status, may have an impact on the efficacy outcome measures. The Company will continue to analyze complete results once they become available, including additional biomarkers."
 
I was really quite hopeful for the various trials this year - given that virtually no drugs had been trialed for ME at any particular scale and that recovery from these diseases is possible, I thought there was a decent chance that throwing a lot of somewhat uninformed darts might lead to something productive.

But it now seems incredibly clear that fundamental research must be prioritised over clinical trials until we have a clear sense of what’s driving the disease.
 
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