The ALS Association

ALS Ice Bucket Challenge Progress

AB Science Reports Interim Trial Results for Drug Masitinib

April 13, 2016

The protein kinase masitinib is showing promise as an ALS therapy, according to a press release by the pharmaceutical company AB Science. They reported positive outcomes; however, the actual interim data is currently not available since the trial is still ongoing. The trial is designed as a phase 2/3 double-blind, placebo-controlled trial that compares efficacy and safety of masitinib in combination with riluzole compared to placebo in combination with riluzole. This interim analysis of their study was carried out when approximately 50% of enrollment was completed.

Here are some key points to this study:

  • According to preclinical studies, masitinib is a type of anti-inflammatory drug that works by blocking inflammatory cells in the brain and spinal cord, thereby potentially improving motor neuron survival (one type of cell that dies in ALS).
  • AB Science reports that interim results show that ALS patients treated with masitinib and riluzole exhibited statistically significant improvements over placebo and riluzole-treated patients according to several tests, including changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) and in forced vital capacity (FVC). Actual data was not reported.
  • This trial is no longer enrolling.
  • Masitinib received orphan drug status by the FDA for ALS, which gives AB Science various incentives through the Orphan Drug Act (ODA), including tax credits for qualified clinical testing, among other incentives.

According to their press release, AB Science plans to host a webcast on masitinib in the upcoming days. The ALS Association looks forward both to learning more about the trial as data becomes available and to seeing the completed study results in the near future. Once the study is fully completed, AB Science will consider the final safety and effectiveness of masitinib.

Click here to read AB Science’s press release. Please contact AB Science with any questions regarding this study.

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