Cytokinetics, Inc. (NASDAQ: CYTK) saw its shares take a massive step back in Tuesday’s session after the firm reported negative results for its trial in amyotrophic lateral sclerosis (ALS). Specifically, the firm’s Phase 3 clinical trial of tirasemtiv did not meet the primary endpoint or any of the secondary endpoints.
This announcement is only adding to Cytokinetics’ recent misery. Over the past month, the stock is down about 24%, excluding Tuesday’s move.
There were no new safety or tolerability findings related to tirasemtiv identified in the trial. Also, 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 primary endpoint, or the decline in slow vital capacity (SVC) from baseline to 24 weeks, was smaller in patients who received any dose of tirasemtiv in the trial 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.
Robert I. Blum, Cytokinetics’ President and CEO, commented on the trial:
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. 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. 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.
Shares of Cytokinetics were last seen down about 32% at $7.53, with a consensus analyst price target of $22.25 and a 52-week range of $7.00 to $17.20.