Multiple sclerosis is one of the absolute success stories in terms of disease-modifying therapy. Nevertheless, the search for new concepts continues and the RED4MS study is looking in a new direction. Neurologist Dr. Andreas Lutterotti and his colleagues are researching and developing a novel approach to retraining the immune system. Find out more about the RED4MS study and how this therapy aims to reduce the symptoms of MS while maintaining normal immune function, offering hope for more targeted and safer treatment.
Dr. Lutterotti provides insights into the study’s objectives, patient eligibility, and what participants can expect. This early study is initially concerned with exploring the safety of the therapy. Only in the second step will the right dose be found that hits the sweet spot between efficacy and tolerability. Find out more about the possible effects of the therapy on daily life, the strict safety measures, and what might happen if the results are positive.
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Table of Contents
Introduction – Who is Dr. Andreas Lutterotti?
I’m Andreas Lutterotti, originally from Austria, now living in Switzerland. I’m a neurologist with a focus on MS and a Chief Medical Officer at Cellaris AG. I’m married, have three children, and enjoy biking and traveling with my family.
Personal motivation for your career choice?
I’ve always found the brain and nervous system fascinating. Early in my career, I felt frustrated by the limited treatment options for MS patients. This motivated me to pursue research and develop new therapies, leading to my role in clinical trials today.
RED4MS: Overview of the Therapy and Potential Benefits
What is the main goal of the RED4MS study, and how could the new medication potentially benefit patients with relapsing-remitting MS?
The main goal of the RED4MS study is to assess the safety and tolerability of a new treatment approach employing autologous red blood cells coupled with antigenic peptides and to provide a proof-of-concept for the efficacy of the treatment in reducing inflammatory disease activity in the brain.
How does this therapy aim to retrain the immune system to stop attacking the brain and spinal cord in MS patients while preserving normal immune function?
As an antigen-specific therapy it targets the immune response directed against the peptides coupled on the surface of the RBCs.
RED4MS: Patient Experience and Eligibility
Who is eligible to participate in the RED4MS study, and what criteria must MS patients meet to be considered?
As key criteria patient must have a diagnosis of relapsing MS with a disease duration less than 10 years and be off any approved disease modifying therapy.x
What can patients expect during the trial, such as the number of visits, the type of assessments, and the general commitment involved?
Patients will have a regular follow-up to assess the safety, tolerability and efficacy of the treatment. Particularly during the treatment phase a thorough safety follow-up will be performed. Overall patient will have 11 visits on site and 4 telephone visits during the 24 week treatment phase. Thereafter, two further visits will be performed at week 32 and week 48 as part of a safety follow up. The visits may include assessment of adverse events and medications used, neurological tests, magnetic resonance imaging and blood draws for safety assessment and immunological studies on the treatment effects.
RED4MS: Impact of the Therapy and Safety Monitoring
What improvements in the daily lives of MS patients are expected if the therapy is successful?
To date we do not know, if the treatment is effective. Hence, at this point in time we can only speculate on improvements in daily lives. But the goal is to have a treatment that is highly specific with regard to its immunological effects and therefore reduces the risks and limitations from currently approved immunosuppressive therapies with regard to infections, vaccinations, family planning and other.
What potential side effects should patients be aware of, and how will their safety be monitored during the trial?
Two prior trials with a comparable approach showed good tolerability of the treatment. One potential risk in such an approach is that one achieves the opposite, i.e. not inducing tolerance but immune activation leading to worsening of disease. We have not seen this in the two prior studies or pre-clinical models. However, we will follow patients very thoroughly for signs of disease activity.
What steps are in place if a patient experiences side effects, and how will the trial ensure that the treatment remains safe?
There is a thorough follow-up in all patients particularly around the time of treatment administration and trial participants should report adverse evets or worsening of disease as early as possible. All reported adverse events and different measures of disease activity will be closely monitored and reported to an independent Data Safety Monitoring Board, which will provide immediate recommendation on any measures to be taken, if necessary.
RED4MS: Dosing and Administration
How are doses administered, and why are there different dosing groups in the study?
The treatment will be given as an intravenous infusion. Patient will receive two treatment cycles during the trial. On each administration day, trial participants receive two bags of the therapy. Depending of the dose a bag can contain peptide-coupled red blood cells (ie the intended therapy) or uncoupled red blood cells (ie. sham treatment).
How does the dose escalation in Part A help determine the dosing strategy for Part B of the study?
The dose escalation in part A will provide data on the safety of the approach. If safety is confirmed all three doses will be used in part B of the trial.
RED4MS: Effectiveness and Expected Outcomes
What are the key markers of success that the study will use to measure how well the treatment works in reducing MS symptoms or slowing disease progression?
The key marker is the reduction in the number of new brain lesions after treatment compared to the baseline phase before the treatment. In addition, we will assess the immunologic effects to understand whether the goal of reducing the autoreactive immune response is achieved.
How could the data from this study impact future MS treatment options?
If this study is successful, it will need further studies to confirm the safety and efficacy of the treatment in more patients. So, it will need more data before any impact on future treatment options can be evaluated.
RED4MS: Long-term Implications and Availability
If the RED4MS study is successful, what are the next steps to make this treatment available to more MS patients?
It will need more studies to confirm safety and efficacy of the treatment.
Could this therapy lead to long-term immune tolerance, reducing the need for ongoing treatments in the future?
We do not know. In preclinical models it has a long-term effect, but we do not know whether this holds true in humans.
Quickfire Q&A Session
Complete the sentence: "For me, multiple sclerosis is...."
…a terrible disease that we need to defeat once and for all.
What development would you like to see in the field of multiple sclerosis in the next 5 years?
I hope we will have therapeutic strategies for efficient neuroprotection and ways to treat important symptoms like fatigue, effectively.
Farewell
Finally, what message of hope or encouragement would you like to share with the listeners?
Treatment development in MS has been very successful in a relatively short period of time. With more focus neuroprotective/-regenerative therapies and improvement of symptoms like fatigue we will hopefully improve the life of patients with MS in the future.
How and where can interested people follow your research activities?
www.clinicaltrials.gov (contains a list of participating centers)
The following countries participate in the trial:
- Germany
- Czech Republic
- Switzerland
- Italy
Good luck with the clinical trial. Sounds like a promising mode of action.
See you soon and try to make the best out of your life,
Nele
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