Cytokinetics Announces New Results Presented at the International Symposium on ALS/MND
Effect of Reldesemtiv: Similar Whether or Not Patients Received Edaravone and/or Riluzole
The results of FORTITUDE-ALS, presented earlier this year at the
For use and non-use of edaravone, the treatment difference for reldesemtiv relative to placebo for ALSFRS-R was 1.25 points (p=0.06) and 0.77 points (p=0.06), respectively. Decline in SVC was 3.07 percentage points less on reldesemtiv versus placebo in patients using edaravone (p=0.14), and 1.21 percentage points less on reldesemtiv versus placebo in patients not using edaravone (p=0.32). HHD declined 6.94 percentage points less on reldesemtiv versus placebo for patients taking edaravone (p=0.14), and 1.31 percentage points on reldesemtiv versus placebo for patients not taking it (p=0.57).
For use and non-use of riluzole, the treatment difference for reldesemtiv compared to placebo for ALSFRS-R was 0.86 (p=0.03) and 0.84 (p=0.28) points, respectively. Decline in SVC was 1.64 percentage points less on reldesemtiv versus placebo (p=0.16) and 1.81 percentage points less on reldesemtiv versus placebo (p=0.46), respectively. Decline in HHD was 2.22 (p=0.36) and 4.36 (p=0.27) less on reldesemtiv versus placebo, respectively.
“The results from these subgroup analyses add to the growing body of evidence regarding the effects of reldesemtiv in patients with ALS,” said
Decline in Quality of Life Moderately Associated with Depression in Placebo Patients
In FORTITUDE-ALS, patients completed measurements of quality of life (QoL) and depression at screening, Day 1, Weeks 2, 4, 8, 12, and at follow-up, 4 weeks after the last dose of double-blind study drug. Patients completed the ALSAQ-5, a QoL instrument heavily weighted to function, which asks about the difficulty of standing, using arms, eating, speaking, and the feeling of hopelessness about the future, where higher scores represent worse QoL. Patients also completed the Beck Depression Inventory Fast Screen (BDI-FS), a scale in which patients choose the most accurate of four statements for seven topics including hopelessness and suicidal thoughts, where higher scores represent worsening depression. Results from 115 placebo patients were analyzed. Mean ALSAQ-5 and BDI-FS scores increased over time and were moderately correlated over time with an overall Spearman correlation coefficient of 0.54 (p < 0.0001), suggesting that as QoL declines in patients with ALS, depression worsens. Age, sex and site of onset were not related to change in depression, but depression scores increased at a slower pace in placebo patients using edaravone.
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that afflicts approximately 20,000 people in
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential benefits of reldesemtiv; Cytokinetics’ continued evaluation of reldesemtiv as a treatment for patients with ALS; and the properties and potential benefits of Cytokinetics’ other drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for reldesemtiv; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics’ collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission.
Vice President, Corporate Communications, Investor Relations
Source: Cytokinetics, Incorporated