Business
Cytokinetics Presents Data at the Virtual 33rd International Symposium on ALS/MND
Analysis from FORTITUDE-ALS Shows Predicted Survival Risk Score Strongly Correlated with Decline in ALSFRS-R Findings Suggest Inclusion Criteria for
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Analysis from FORTITUDE-ALS Shows Predicted Survival Risk Score Strongly Correlated with Decline in ALSFRS-R Findings Suggest Inclusion Criteria for COURAGE-ALS Will Enrich for the Enrollment of Faster Progressors SOUTH SAN FRANCISCO, Calif., Dec. 08, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data were presented at the Virtual 33rd International Symposium on ALS/MND related to survival predictions from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in ALS. “This analysis from FORTITUDE-ALS helps to build our understanding of disease progression in ALS, which is complex and heterogenous, and is an important element in the conduct of clinical research and the design of our clinical trials,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Given the urgent need to deliver new therapies for people with ALS, it’s essential that clinical trials are designed with rigor to enhance the sensitivity of detecting a potential treatment effect. This analysis suggests the inclusion criteria we selected for the ongoing Phase 3 trial, COURAGE-ALS, may have the intended outcome of enrolling patients most likely to benefit from the investigational therapy. We look forward to continuing the conduct of COURAGE-ALS and completing patient enrollment in the first half of 2023.” Predicted Survival Risk Score for Participants in FORTITUDE-ALS Strongly Correlated with Decline in ALSFRS-R In a previously presented post-hoc analysis of disease progression in FORTITUDE-ALS, patients were grouped into tertiles according to their pre-study rate of decline in the ALS Functional Rating Scale Revised (ALSFRS-R) total score. The largest treatment effect from reldesemtiv was observed in the intermediate and fast progressing tertiles. Most patients in these two tertiles had experienced symptoms for ≤24 months and had a baseline ALSFRS-R total score ≤44 (referred to as the 24/44 criteria). In this analysis, the ENCALS survival model was used to calculate a predicted survival risk score for all participants in FORTITUDE-ALS. The ENCALS survival model calculates the risk score based on several factors, including age at onset, onset s...