Cytokinetics Announces Data From Its ALS Program Presented at the 32nd International Symposium on ALS/MND
Majority of Initial Patients Enrolled in COURAGE-ALS Show Intended Middle to Fast Disease Progression Phenotype at Baseline
SOUTH SAN FRANCISCO, Calif., Dec. 10, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data were presented at the 32nd International Symposium on ALS/MND including an analysis of baseline characteristics from the initial patients enrolled in COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the ongoing Phase 3 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS). In addition, supplemental analyses 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, were presented, as were results from the IMPACT ALS Europe survey, a patient and caregiver survey funded in part by Cytokinetics.
“The analysis of patients enrolled to date in COURAGE-ALS shows that the great majority of patients have middle and fast pre-study disease progression rates, which was our objective after observing in FORTITUDE-ALS that the treatment effect of reldesemtiv was greater in patients with faster disease progression,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “While we are not excluding slow progressors, by adjusting the inclusion criteria to enrich the population for faster rates of progression, we may be able to increase the sensitivity of detecting a potential treatment effect of reldesemtiv. We look forward to continuing COURAGE-ALS.”
COURAGE-ALS: Analysis of Baseline Characteristics for First 27 Patients Enrolled
Stacy Rudnicki, M.D., Vice President, Clinical Research, Cytokinetics, presented an analysis of the baseline characteristics of the first 27 patients enrolled in COURAGE-ALS. COURAGE-ALS is a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv expected to enroll approximately 555 patients with ALS. Analyses conducted post hoc from FORTITUDE-ALS, the completed Phase 2 clinical trial of reldesemtiv, suggested that treatment effects were more evident in patients with faster rates of disease progression. These findings informed the inclusion criteria for COURAGE-ALS with the aim of enrolling a higher proportion of patients with middle to fast disease progression. Key inclusion criteria in COURAGE-ALS include symptom onset within 24 months and ALS Functional Rating Scale-Revised (ALSFRS-R) total score of ≤44. COURAGE-ALS began enrolling patients in August 2021, and 27 patients had been enrolled at the time of this analysis. The disease progression rate of each patient prior to enrollment was estimated using a formula based on ALSFRS-R score at entry into the trial and duration of ALS symptoms; progression rates were categorized as slow (≤0.37 points per month), middle (>0.37–0.67 points per month) and fast (>0.67 points per month). These categories were defined by equally dividing the disease progression rates of patients enrolled in FORTITUDE-ALS into tertiles. In COURAGE-ALS, the majority of the patients enrolled at the time of this analysis were middle progressors (48.2%) or fast progressors (37.0%). From this analysis it appears that adjusting the inclusion criteria in COURAGE-ALS is achieving the intended goal of increasing the proportion of patients with middle to fast disease progression rates, as compared to FORTITUDE-ALS.
FORTITUDE-ALS: Grip Strength Correlated with Fine Motor Function and Arm Function
Andrew Wolff, M.D., Senior Vice President, Senior Fellow, Clinical Research and Development, Cytokinetics, presented supplemental analyses from FORTITUDE-ALS evaluating the relationship between declining grip strength and motor function. In FORTITUDE-ALS, secondary and exploratory endpoints included change from baseline in the ALSFRS-R, in which higher scores represent better physical function, change from baseline in the ALS Assessment Questionnaire (ALSAQ-5), a patient reported measure of health status in which higher scores represent worse quality of life, and change from baseline in grip strength. Measurements for ALSFRS-R, ALSAQ-5, and bilateral grip strength were collected at Screening, Day 1, Weeks 2, 4, 8, 12 and Follow-up. For all seven time points collected, average grip strength was strongly correlated with the ALSFRS-R fine motor domain sub-score with an overall Spearman correlation coefficient of 0.723 (p
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