Hoping to fight the brutal Huntington’s disease, Roche signed a licensing agreement with Ionis in 2017 for a new antisense therapy targeting a protein involved in the disease. Now, having avoided safety red flags earlier, Roche is calling for an advanced-stage study to be closed on the orders of a data committee.
Roche halted dosing in its Phase III study of tominersen, an antisense drug targeting the huntingtin protein and a mutant variant, after an independent data committee “made its recommendation based on the potential benefit / risk profile of the treatment. for study participants, ”the Swiss drug giant said.
Roche in the licensed tominersen, formerly IONIS-HTTRx, in 2017 and had so far enrolled 791 patients in 18 countries in the phase III GENERATION HD1 study prior to discontinuation of treatment. The double-blind, placebo-controlled study tested tominersen in patients with overt Huntington’s disease for more than 25 months, randomized to receive a 120 milligram dose of the drug every two months, one dose of 120 milligrams every two months. every four months or a placebo.
Roche also discontinued dosing in an open-label extension study called GEN-EXTEND dosing patients following the same protocol at high and low doses. The company said it will provide further updates on its plan for the drug once the data is assessed and planned to continue monitoring patient safety signals throughout the study’s trial window.
“This is very unfortunate news to deliver on the tominersen phase III study and we know that it will be particularly difficult for people with Huntington’s disease to hear,” CMO Levi Garraway said in a statement.
Roche stressed that new security risks were not at stake in the committee’s decision. That would end some concerns that the safety signals that derailed another Phase I study were carried over into the late stage test.
Last March, Roche suspended recruitment for this study, dubbed GEN-PEAK, after investigators noted two cases of catheter-related intrathecal infections that were unrelated to the drug. This study was continued afterwards and Roche said he had no plans to abandon it now.
Ionis collected a $ 45 million royalty from Roche when implementing the pact at the end of 2017. Roche believes this is a new and better way to stop the production of huntingtin protein. (HTT), linked to the development of the fatal disease. .
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