Corcept presents interim results of DAZALS study

The aim of the DAZALS study was to investigate different doses of the drug ‘dazucorilant’ versus a placebo group. Researchers mainly looked at the effect on the ALSFRS-R score, also called the primary endpoint. It was expected that one or both groups with dazucorilant would score better than the placebo group on the ALSFRS-R. Unfortunately, the results showed that this was not the case.

The interim results did reveal that the group that received the active drug had a better chance of survival compared to the placebo group. This is an interesting finding and therefore Corcept is continuing with the OLE of this study to find out more about the effect on survival. Survival and improvement in quality of life are both so-called secondary endpoints, which are effects that are investigated at a secondary stage. We therefore have to wait for the full results before we can draw any real conclusions about the efficacy of the drug dazucorilant.

Dazals

DAZALS is a phase 2 study with a duration of 24 weeks in which all participants had to take the study drug daily. During the study, participants were randomly and double-blindly assigned to one of the participant groups: the drug containing dazucorilant or the placebo group. Random and double-blind means that neither the doctor nor the patient knows which group the participant is assigned to.

A total of 249 people with ALS from America, Canada and Europe participated in the study. They had a 2:3 chance of being assigned to one of the dazucorilant groups.

After this 24-week period, everyone was given the chance to participate in the open-label phase. During this period – which may last up to 132 weeks per person – all participants received dazucorilant. Many participants are currently still in this phase of the study. They are being closely monitored – as they were before this news release – and are aware of these results.

Reaction TRICALS

We want to thank all the study participants for their commitment and time. Without them, none of the studies would be possible. Unfortunately, results of studies can also be negative, but that does not mean that all the effort and commitment has been in vain. All results provide a lot of knowledge and leads for follow-up research. That is why it is so important to continue participating in medicine studies.

And that is exactly what is going on with this study; the first result (ALSFRS-R) may be negative, but the results also show that there are other leads that the drug is effective for people with ALS. We are going to continue with the OLE and study the results further. We remain hopeful and motivated to find that a treatment for all people with ALS.