SAN DIEGO, June 17 Bio International Convention 2008(http://www.bio2008.org) -- HUYA Bioscience International(http://www.huyabio.com), the leader in U.S./China pharmaceuticalco-development, today announced the outcome of its pre-investigational newdrug (IND) consultation meeting with the United States Food and DrugAdministration (FDA) for HBI-3000 (Sulcardine sulphate), a promisinganti-arrhythmic compound sourced from China. The Agency reviewed and agreedwith HUYA's IND-enabling CMC and toxicology plans and high level Phase I planspending review of non-clinical and clinical data to be submitted as part ofthe complete IND package. The FDA also agreed to accept data generated inChina as 'supportive information' that will support the submission of a U.S.IND and the initiation of a U.S. Phase I trial. HUYA anticipates filing an INDapplication for HBI-3000 in Q1 2009.
"We're very pleased that the FDA will accept Chinese data to supportclinical study design and initiation in the U.S., as this validates ourco-development method," said Mireille Gingras, PhD, CEO, HUYA. "We continue tofind that in working with China, we can lower the risk and increase theefficiency of drug development in areas of significant unmet need. HUYA isproud to lead the way in co-developing new and important drugs that may savelives."
HBI-3000 is a novel, multi-ion channel blocker for the treatment of atrialor ventricular arrhythmias. In April 2008, HUYA announced the completion ofthree Phase I protocol studies of HBI-3000 (oral) in China. These clinicalstudies demonstrated that oral administration of HBI-3000 was well tolerated.The compound has also been tested in an intravenous (IV) formula allowing itto address both in-hospital acute cases and long-term management of chronicarrhythmia.
Most existing marketed and development-stage anti-arrhythmics have beenassociated with adverse events such as Torsade de Pointes (TdP - sudden death)or appreciable QTc prolongation (a risk factor for sudden death) in Phase I orpreclinical studies. As noted above, in the preclinical studies and the threePhase I studies completed in China, HBI-3000 was well tolerated.
Atrial Fibrillation (AF) is a serious type of arrhythmia found inapproximately 2.2 million Americans and about 15 percent of strokes occur inpeople with AF(1). Ventricular Arrhythmia (VA), a severely abnormal heartrhythm, will cause death unless treated immediately. Ventricular fibrillation(VF), a type of arrhythmia, is responsible for 75 to 85 percent of suddendeaths in persons with heart problems(2).
Currently, anti-arrhythmic drugs are commonly used to treat patients withAF and VA, though in treating patients with VA, most anti-arrhythmics havefailed to demonstrate a survival advantage. In some cases they may also carrysafety risks, including sudden death. Pre-clinical data developed by HUYA andits Chinese partner, along with the Chinese clinical trial data areencouraging to suggest that HBI-3000 may have a useful role in the treatmentof ventricular arrhythmias.
In the United States, HBI-3000 is initially being developed andinvestigated for use as IV treatment of atrial fibrillation with clinicaltrials expected to begin in early 2009. "This is a significant area ofmedicine for which providers need more options to treat patients," continuedGingras. "Researchers in China are developing promising compounds that wouldfulfill these and other unmet medical needs in the U.S. As we prepare toassemble the data and submit our IND to initiate the Phase I trials, we'llcontinue to leverage our collaboration and expertise in China and the U.S.It's exciting to think of the amount of time and funding that could be savedby optimizing and streamlining the development process."
HUYA's innovative co-development model
HUYA was one of the first companies to recognize China's potential to helpmeet the gl