Cytokinetics announces negative results from VITALITY-ALS.
Cytokinetics, Incorporated announced that VITALITY-ALS, the international Phase 3 clinical trial of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS), did not meet the primary endpoint of change from baseline in slow vital capacity (SVC) which was evaluated at 24 weeks following randomization or any of the secondary endpoints in the trial which were evaluated at 48 weeks.
No new safety or tolerability findings related to tirasemtiv were identified in VITALITY-ALS. Serious adverse events were similar between patients who received tirasemtiv or placebo but more patients discontinued double-blind treatment on tirasemtiv than on placebo primarily due to non-serious adverse events related to tolerability.
The decline in SVC from baseline to 24 weeks was smaller in patients who received any dose of tirasemtiv in VITALITY-ALS compared to the decline in patients receiving placebo. The largest differences from placebo were observed in patients randomized to the mid- and high-dose groups of tirasemtiv who could tolerate and remain on their target dose, although those differences were not statistically significant.
“While we are deeply disappointed by the results of VITALITY-ALS, we remain committed to people with ALS who are fighting this devastating disease and who need new therapies to slow the decline of respiratory function and muscle strength that are key hallmarks of disease progression,” said Robert I. Blum, Cytokinetics’ president and CEO. “We have decided to suspend the development of tirasemtiv.
“While we believe that VITALITY-ALS demonstrated pharmacologic activity for the mechanism of action, we also believe that limitations of tirasemtiv may be addressed with our next-generation fast skeletal muscle activator, CK-2127107,” Blum continued. “Based on previous Phase 1 clinical studies, we believe CK-2127107 will be better tolerated and potentially more effective than tirasemtiv in patients with ALS and look forward to Phase 2 trial results in 2018. We are grateful to the trial investigators, site personnel, patients and caregivers who participated in VITALITY-ALS.”
The results of VITALITY-ALS will be presented on December 8, 2017 at the 27th Annual International ALS/MND Symposium in Boston by Jeremy Shefner, M.D., Ph.D., lead investigator of VITALITY-ALS, professor and chair of neurology at Barrow Neurological Institute, and professor and executive chair of neurology at University of Arizona, Phoenix.
(Source: Cytokinetics, Inc.)
Filed Under: Drug Discovery