In collaboration with Astellas Pharma Inc, Cytokinetics have announced that they are now enrolling for a phase 2 clinical trial investigating the efficacy, safety and tolerability of CK-2127107, or CK-107, in people living with ALS. CK-2127107 is a next generation fast skeletal muscle troponin activator (FSTA). Like tirasemitv, Cytokinetics’s other drug candidate for the treatment of ALS, CK-107 is designed to slow the release of calcium with the intent of improving muscle function and mobility. Although tirasemtiv and CK-107 are similar, they are two different small molecules, as such, they each require individual clinical development programs. CK-107 is currently the subject of three other clinical trials; two phase 2 trials investigating its effect in Spinal Muscular Atrophy (SMA) and Chronic Obstructive Pulmonary Disease (COPD), and a phase 1b trial to assess its efficacy on fatigue in elderly participants with limited mobility.
This randomized, placebo controlled study, also known as FORTITUDE-ALS, aims to enroll approximately 450 patients living with ALS from the US and Canada. Participants will be randomized equally into 4 groups. Three of these groups will receive either 150mg, 300mg or 450mg of the treatment orally twice per day and the fourth group will receive the placebo for a period of 12 weeks. The primary endpoint of this study is to assess the change from baseline to week 12 in the percent predicted slow vital capacity (SVC). Secondary endpoints include changes in muscle strength, measured by hand held dynamometry (HHD), and in the ALS Functional Rating Scale – Revised (ALSFRS-R).
In order to qualify for enrollment, participants must have been diagnosed with ALS within the previous 24 months and have a SVC of no less than 65% predicted value for age, height and gender at the time of screening. People with ALS taking a steady dose of Riluzole for 30 days or more are permitted for enrollment . Individuals who participated in any trials investigating the use of tirasemtiv or CK-107 are excluded from enrollment. A full description of this clinical trial including contact information can be found online here. Updates on site enrollment status and other changes to the study are monitored by ALS TDI and sent monthly via email to those subscribed to the clinical trial mailing list.
It is important to note that Cytokinetics expects to announce results from the phase 3 – VITALITY-ALS – trial of tirasemtiv by the end of 2017, likely at the International Research Symposium on ALS/MND in Boston this December. It is also important to acknowledge, that although those that have taken tirasemtiv in the past are not invited to participate in this new trial, the company has launched a unique program called “VIGOR-ALS” in which individuals who completed the recent phase 3 trial can continue to access tirasemtiv after that trial ends.
Clinical Trial Database
Cytokinetics Drug Description
Cytokinetics Press Release on Phase 2 Study