TRICALS Milestones

Up until now, TRICALS has been the largest research initiative in Europe for finding a treatment for ALS, PSMA and PLS. Our research network currently consists of 48 centres in 15 European countries. Our network is continually expanding. In 2021 alone, 3 new ALS expertise centres from Portugal, Spain and England joined TRICALS. When a new trial begins, with our widespread network we can quickly recruit a large number of participants.

TRICALS is continually committed to making clinical trials more accessible for everyone with ALS, PSMA and PLS. By using advanced mathematical models, we ensure that many more people are eligible to take part. Using these models, we can also shorten the duration of studies, reduce the number of hospital visits required and reduce the exposure to placebos. These models will be applied in 2021 in the drug studies developed by TRICALS.

TRICALS has set up an international patient database. In this database, we collect research data from people with ALS, PSMA and PLS. We use this data to inform people directly when a clinical trial is starting and to improve the design of trials. Do you wish to register with TRICALS? Then register here.

In 2020, we launched our new English language website. From May, this will also be available in Dutch, Spanish, French, Italian and Swedish. People who take part in clinical trials receive an update once every 3 months about the research that they are taking part in. Finally, we are currently sending newsletters in English and in Dutch 4 times per year. In this newsletter, you will read about ongoing studies and other news reports from TRICALS. Would you like to receive our newsletter? Then register here.

In 2019, TRICALS was officially launched in Utrecht. We did this along with researchers and pharmaceutical companies. Due to the considerable success, we decided to make the Masterclass an annual reoccurring event. In this way, we remain in contact with each other about accelerating and improving drug studies. During the Masterclass, we give an overview of where we are at with TRICALS and subsequently also organise a training day for researchers. Unfortunately, this year, as a result of Covid-19, we were unable to give a Master class and we are working hard to organise this again in 2022.

In November 2020, we gave an online webinar about the efficient inclusion of participants in clinical studies into ALS. The webinar was aimed in particular at people from the pharmaceutical industry and was given in collaboration with Julius Clinical. More than 70 people had registered for the webinar. You can view the webinar here.

In December 2020, the International MNDA Symposium 2020, in which TRICALS participated, was held online. This is the largest medical and scientific congress of experts in the field of ALS, PSMA and PLS and takes place annually. Dr. Ruben van Eijk gave a presentation about his mathematical model with the aim that more patients can take part in clinical studies. Click here to read a brief summary of our highlights from this year.

In order to raise money for TRICALS, within 24 days Daniel Rossinés swam along the entire Catalan coast (400 km!). With this impressive action, he raised €85,000! We thank him and everyone who donated or joined him for their support in our mission to accelerate the search for new treatments for people with ALS, PSMA and PLS. Read more about the action. If you also wish to start an event to raise funds for TRICALS, you can do so here.

Our models and set-up for a platform trial (see also under the heading MAGNET) for improving drug studies were assessed positively in July 2020 by the European Medicines Agency (EMA). The agency hereby gives the green light for carrying out future drug studies in a more efficient way and making them more widely accessible for more patients.

Traditional studies into drugs for ALS are very expensive, take a long time and are often not accessible to the vast majority of the patients. TRICALS has therefore developed an innovative clinical study by means of a so-called Master Protocol (the MAGNET study). In this way, we can test several drugs at the same time. This protocol can also be used by pharmaceutical companies. In addition, new candidate drugs can easily be added. The Master Protocol of the MAGNET study has meanwhile been assessed positively by the EMA.

Our research has shown that the effect of a drug can be influenced by the genetic format. For instance, we made the discovery that the drug Lithium potentially has a delaying effect in people with ALS who carry a mutation in the UNC13A gene. TRICALS will further research this with the aid of the MAGNET study (see ‘Master protocol: MAGNET’). This study is currently in the early preparation stages. As soon as the study begins, people who are registered at TRICALS will be the first to be informed about this.

From laboratory research, indications have emerged that a virus called ‘endogenous retrovirus’ can play a role in the development of ALS. Triumeq is an existing drug which potentially offers protection against this virus. We will therefore research whether Triumeq can slow down the progression of ALS. This study is currently in the early preparation stages. As soon as the study begins, people who are registered at TRICALS will be the first to be informed about this.

In order to accelerate drug research into ALS, PSMA and PLS, we want to take as many studies as possible to Europe. Thanks to our unique network, TRICALS is an interesting partner for pharmaceutical companies. Since the set-up of TRICALS, we have worked actively on 3 trials by various pharmaceutical companies (see a few examples below) as well as giving advice for the development of drug studies. In 2021, we are also contributing to 4 different studies in collaboration with pharmaceutical companies. As soon as a new study begins, people who are registered with TRICALS are the first to be informed about this.

In April 2021, Amylyx Pharmaceuticals made plans for the further development of their drug ‘AMX0035’ for the treatment of ALS. They announced that they will apply for a licence from the European Medicines Agency (EMA) in order to put the drug on the European market. Furthermore, after promising results from the CENTAUR study, Amylyx plans to start a phase 3 clinical trial in Europe and the United States. TRICALS will collaborate with Amylyx on the European part of their phase 3 study.

TRICALS is working together with Biogen on their VALOR study. This clinical trial is researching the safety and effectiveness of the drug BiiB067 for people with ALS who carry a SOD1 gene mutation. Worldwide, 40 centres are taking part in the study, including 6 TRICALS centres. Read more here about the study.

From TRICALS, we publish scientific articles about our research on a regular basis. In 2020, on behalf of TRICALS, we wrote a scientific article which describes our main recommendations for better drug research for ALS. We present our work at large international congresses and have received beautiful awards for our research.

Twenty years ago, the ALSFRS questionnaire was revised. This questionnaire is an important instrument for evaluating the disease progression of people with ALS in drug research. A new study by researchers from the ALS Centrum Nederland shows that the original ALSFRS is actually better at detecting small treatment effects than the revised version. Click here to read the news report.

Researchers from the ALS Centrum Nederland analysed the set-up and execution of current clinical studies into ALS. Their findings were published in 2020 in a scientific article. Click here to read the news report.

In order to find new treatments for ALS, PSMA and PLS, our current strategy for drug development must change. We have published our deliberations and suggestions in a scientific journal. On the basis of our findings, TRICALS will tackle five important points which must be improved in order to help research to progress. Click here to read the news report.

In 2020, dr. Ruben van Eijk won the prestigious Paulo Gontijo prize for his pioneering research into broadening inclusion criteria for trials into ALS. His research shows that with the aid of advanced, mathematical models, we can let many more people take part in clinical studies (see also ‘More Accessible Trials’).

As TRICALS, we give training courses on a regular basis into outcome measures which are important in clinical trials. This concerns for instance taking specific questionnaires, cognitive tests or lung function tests.