In a study sponsored by ARCA Biopharma ($ABIO) and carried out by a number of U.S. universities, a pharmacogenetic test predicted which patients would respond to the company's beta blocker and vasodilator bucindolol (Gencaro), in development for the treatment of chronic heart failure. The level of clinical activity of this oral drug depends on two changes in two genes.
The researchers screened more than a thousand of the patients with congestive heart failure who took part in the Beta-Blocker Evaluation of Survival Trial (BEST) and were given either bucindolol or dummy pills. Based on the patients' clinical results and genetic profile, the team created a "genetic scorecard." The results were published in PLoS ONE.
A biomarker for bucindolol will not only speed it through development but could also be used to point out those patients who will (and won't) respond to which drug, sparing those patients who won't respond the risk of potential side effects.
According to Stephen B. Liggett of the University of South Florida and founder of ARCA Biopharma, the researchers were able to use the two-gene test to "identify individuals with heart failure who will not respond to bucindolol and those who have an especially favorable treatment response. We also identified those who will have an intermediate level of response. The results showed that the choice of the best drug for a given patient, made the first time without a trial-and-error period, can be accomplished using this two-gene test."
Bucindolol has been designated as a fast track development program for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.
- read the press release
- see the paper