According to the American Heart Association, or AHA, approximately 5.7 million Americans are currently living with heart failure, a condition in which the heart is unable to pump enough blood to meet the body’s metabolic needs. We estimate that there are more than 2.0 million patients in the United States that fall within our initial target population, advanced chronic heart failure, for whom there are limited therapeutic options.
Through the completion of multiple Phase 2 clinical trials, JVS-100 has been delivered to more than 180 patients with no drug-related serious adverse events. In these trials, JVS-100 has demonstrated potential therapeutic efficacy for patients with advanced chronic heart failure. Detailed synopses of Juventas’ clinical studies in heart failure are available through the following links:
In our exploratory Phase 2 heart failure trial, STOP-HF, we assessed safety and efficacy of a single administration of JVS-100 in patients with symptomatic heart failure due to a prior history of heart attack. For the full patient population in this trial, JVS-100 demonstrated dose-dependent trends toward improvement in cardiac function, structure and clinical status. Our pre-specified sub-analyses in STOP-HF demonstrated these improvements were (i) most pronounced in patients with the weakest hearts and (ii) of a magnitude that has been shown to correlate with long-term improvements in mortality and morbidity in patients with heart failure.
JVS-100 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced ischemic chronic heart failure.