Cytokinetics New Data Presented at the International Symposium on ALS/MND

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data were presented at the 29^th International Symposium on ALS/MND in Glasgow, Scotland, UK, including patient baseline characteristics and demographics from FORTITUDE-ALS, the Phase 2 clinical trial of reldesemtiv in patients with ALS. In addition, posters presented at the conference contained data from an analysis of the correlation between slow vital capacity (SVC) measured at home and in the clinic in FORTITUDE-ALS, additional analyses from VITALITY-ALS, the Phase 3 clinical trial of tirasemtiv in patients with ALS, new results from IMPACT ALS, a patient and caregiver survey conducted by The ALS Association and funded in part by Cytokinetics, and results from analyses conducted by Origent Data Sciences on the validation of machine learning models to predict ALS disease progression using data from VITALITY-ALS.

FORTITUDE-ALS, a Phase 2 clinical trial of reldesemtiv designed to assess the change from baseline in percent predicted SVC and other measures of skeletal muscle function after 12 weeks of treatment with reldesemtiv in patients with ALS, completed enrollment in November 2018. The trial enrolled 458 patients with ALS from centers in the U.S., Canada, Europe and Australia.

Baseline characteristics of patients enrolled in FORTITUDE-ALS are similar to those of other recent large clinical trials in ALS, including BENEFIT-ALS and VITALITY-ALS. Patients enrolled in FORTITUDE-ALS were on average 58.7 years of age, 60.7 percent male, 8.4 months from diagnosis, 22.9 months from their first symptom and had an average percent predicted SVC of 86.8 percent. Regarding other therapies for ALS, the majority of patients were taking only Rilutek® (riluzole) (259, 56.6%), while 19 (4.1%) were taking only Radicava® (edaravone), 94 (20.5%) were taking both riluzole and edaravone, and 86 (18.8%) were taking neither. Demographics and baseline characteristics were similar among patients who received riluzole alone, edaravonealone, received both or received neither.

“We are encouraged to see that the baseline characteristics from FORTITUDE-ALS are consistent with previous ALS trials, and are pleased to be able to share them with the ALS community,” Jeremy Shefner, M.D., Ph.D., Lead Investigator of FORTITUDE-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at the University of Arizona, Phoenix. “With enrollment now complete in this trial, we look forward to learning how reldesemtiv may impact slow vital capacity and other measures of skeletal muscle function to potentially complement current therapies for patients bravely battling ALS.”

https://www.marketscreener.com/CYTOKINETICS-INC-13479846/news/Cytokinetics-Announces-New-Data-Presented-at-the-International-Symposium-on-ALS-MND-27730614/