The pharmaceutical company Ferrer has announced their first results of the ADORE clinical trial. Unfortunately, analysis of data showed that the investigated drug edaravone was not effective.
The ADORE study is a phase 3 study in which they tested the efficacy and safety of the 100 mg edaravone (FAB122) taken orally each day for the period of 48 weeks. The study was conducted with the support of TRICALS. Worldwide, 300 participants were enrolled in the study.
The first analysis of the data showed that the clinical trial did not meet the intended endpoints. Participants taking the drug did not have slowed down disease progression compared to participants taking a placebo (fake drug). Because of these results, Ferrer concluded that the treatment with edaravone was not effective. The results of the study did conclude that the product was safe and well tolerated by participants.
Based on the lack of efficacy of edaravone, the company also announces the conclusion of the open-label extension study ADOREXT. In this study, Ferrer tested the long-term safety of the drug.
All participants have been personally notified on the results and the conclusion of the studies. The closure of current study has no effect on other ongoing clinical trials.
Prof. Leonard H. van den Berg, Chair of TRICALS, Professor of Neurology at the University Medical Centre Utrecht, The Netherlands, and Principal Investigator of the study declares: “As TRICALS we had hoped for a different outcome of the ADORE study and are disappointed that this is not the positive result we all wanted. We will continue to do our utmost to find a treatment for ALS as soon as possible. We want to thank all the participants who dedicated their time and effort to this trial and Ferrer for the good collaboration.”