ARCA biopharma Inc. (NASDAQ:ABIO) is a biopharmaceutical organization employing clarity medicinal approach to developing therapies on Cardiovascular illness.
The company has announced the completion of a patient follow-up for Genetic-AF, a double blind clinical trial that evaluates Gencaro as a possible genetically targeted medication for Atrial Fibrilliation (AF).
ARCA fully acknowledges the completion of patient treatment as a significant clinical milestone hence the company is looking forward to reporting a top line data for the trials for which it estimates will include nearly 50 percent more events than the previous interim analysis.
Genetic AF is a superiority clinical trial that aims to making a comparison of the safety of Genraco to that of Toprol-xl for the treatments and preventions of the recurrent atrial fibrillation in the heart failure with a reduced level in the left ventricular ejection fraction.
The genetic AF data and safety monitoring Board has conducted a pre-specified interim analysis in August. The board thereafter recommended for a completion of the phase 2B trials and has shown that there were no protection concerns.
Genetic AF had enrolled 267 victims from Europe, the United States and Canada and their initial analysis was done to make an evaluation of the evidence of safety of Gencaro against active controls with a demonstrated efficiency and the safety for the patient’s population.
The trial’s original endpoints was to recurrent AF, atrial flutter or all-cause mortality. The trial was however not powered to a regular significance for this end-point and utilized Bayesian statistical modelling of predictive probability of success to estimate the outcome of the trial.
Gencaro demonstrated alike treatment benefit in all patients in comparison compared to the active control. It was generally safe and well tolerated with about 84 percent of the victims being able to attain their target dosages.
ARCA plans to have a meeting with the U.S food and drug administration in the second quarter of this year to be able to make a review of Gencaro phase 2 information and the possibilities of a potential phase 3 development plan.
ARCA ended the year 2017 with marketable securities of about $11.8 million, cash and cash equivalents for which the company believes will be able to fund its 2018 projects.