Cytokinetics Reports Presentation Of Exploratory Analyses Of Data From EMPOWER

(RTTNews) - Cytokinetics Inc. (CYTK) announced the presentation of exploratory analyses of data from EMPOWER, a Phase 3 clinical trial of dexpramipexole in patients with ALS, which demonstrated the rate of decline of slow vital capacity (SVC) predicts the risk of meaningful clinical events, including a decline in the three respiratory questions of the ALSFRS-R, as well as the time to the first occurrence of respiratory insufficiency, tracheostomy or death. Data from placebo-treated patients in EMPOWER were provided to Cytokinetics by Knopp Biosciences.

Vital capacity measures the amount of air expelled from the lungs after a maximum inhalation and is used to assess the strength of the skeletal muscles responsible for breathing (e.g., the diaphragm).

Vital capacity is often expressed in terms of the percentage of the normal value predicted for the individual patient's sex, age, and height; i.e., percent predicted vital capacity. It has been shown to be an important predictor of disease progression and survival in previous clinical trials in patients with ALS who typically die of respiratory failure. Percent predicted vital capacity declines an average of 2.5-3 percentage points per month in patients with ALS and is the most frequently monitored measure of respiratory function to measure disease progression.

The overall slope of decline in percent predicted SVC from baseline through the follow-up period of 1.5 years was -0.090 percentage points per day (2.73 percentage points per month).

Older subjects (greater than 65) had a steeper slope of decline in SVC (-0.12 percentage points per day), as did subjects with baseline ALSFRS-R less than 39 (-0.10 percentage points per day).

A slowing in the decline in SVC by 0.05 percentage points per day from baseline to the month 6 visit predicted reduction in risk by 19% of any decline in the respiratory subdomain of ALSFRS-R or death; by 22% for the first onset of respiratory insufficiency or death; by 23% for first occurrence of tracheostomy or death; and by 23% for death at any time after the month 6 visit (p < 0.0001 for all).