FDA Feedback Supports Innovative Co-development Model
SAN DIEGO, June 17 /PRNewswire/ -- Bio International Convention 2008 (http://www.bio2008.org) -- HUYA Bioscience International (http://www.huyabio.com), the leader in U.S./China pharmaceutical co-development, today announced the outcome of its pre-investigational new drug (IND) consultation meeting with the United States Food and Drug Administration (FDA) for HBI-3000 (Sulcardine sulphate), a promising anti-arrhythmic compound sourced from China. The Agency reviewed and agreed with HUYA's IND-enabling CMC and toxicology plans and high level Phase I plans pending review of non-clinical and clinical data to be submitted as part of the complete IND package. The FDA also agreed to accept data generated in China 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 IND application for HBI-3000 in Q1 2009.
"We're very pleased that the FDA will accept Chinese data to support clinical study design and initiation in the U.S., as this validates our co-development method," said Mireille Gingras, PhD, CEO, HUYA. "We continue to find that in working with China, we can lower the risk and increase the efficiency of drug development in areas of significant unmet need. HUYA is proud to lead the way in co-developing new and important drugs that may save lives."
HBI-3000 is a novel, multi-ion channel blocker for the treatment of atrial or ventricular arrhythmias. In April 2008, HUYA announced the completion of three Phase I protocol studies of HBI-3000 (oral) in China. These clinical studies demonstrated that oral administration of HBI-3000 was well tolerated. The compound has also been tested in an intravenous (IV) formula allowing it to address both in-hospital acute cases and long-term management of chronic arrhythmia.
Most existing marketed and development-stage anti-arrhythmics have been associated with adverse events such as Torsade de Pointes (TdP - sudden death) or appreciable QTc prolongation (a risk factor for sudden death) in Phase I or preclinical studies. As noted above, in the preclinical studies and the three Phase I studies completed in China, HBI-3000 was well tolerated.
Atrial Fibrillation (AF) is a serious type of arrhythmia found in approximately 2.2 million Americans and about 15 percent of strokes occur in people with AF(1). Ventricular Arrhythmia (VA), a severely abnormal heart rhythm, will cause death unless treated immediately. Ventricular fibrillation (VF), a type of arrhythmia, is responsible for 75 to 85 percent of sudden deaths in persons with heart problems(2).
Currently, anti-arrhythmic drugs are commonly used to treat patients with AF and VA, though in treating patients with VA, most anti-arrhythmics have failed to demonstrate a survival advantage. In some cases they may also carry safety risks, including sudden death. Pre-clinical data developed by HUYA and its Chinese partner, along with the Chinese clinical trial data are encouraging to suggest that HBI-3000 may have a useful role in the treatment of ventricular arrhythmias.
In the United States, HBI-3000 is initially being developed and investigated for use as IV treatment of atrial fibrillation with clinical trials expected to begin in early 2009. "This is a significant area of medicine for which providers need more options to treat patients," continued Gingras. "Researchers in China are developing promising compounds that would fulfill these and other unmet medical needs in the U.S. As we prepare to assemble the data and submit our IND to initiate the Phase I trials, we'll continue 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 saved by 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 help meet the global need for untapped sources of pre-clinical and clinical stage compounds for the drug development process. Leveraging the HUYA Integrated Co-development Model for partnering with Chinese research institutions and pharmaceutical companies, HUYA identifies and licenses the most promising pre-clinical and clinical stage compounds in China. Through collaborations with its Chinese partners, the company provides a bridge into the Western development process and biopharma market.
Compounds are validated through a rigorous discovery, selection and development process in China, streamlining and accelerating development in the West, while confirming a compound's safety profile. HUYA's model relies on longevity of relationships with its Chinese partners to provide a continuous source of compounds rather than a one-time single compound strategy.
One of the key differentiators of HUYA's approach is the assembly of a high-level team of scientific and clinical advisors for each new compound. The team collaborates with its Chinese partners to discuss and design clinical trials as the compounds enter the U.S. development process, speeding the process and mitigating risk. HUYA's global team of scientists and clinicians includes Benedict Lucchesi, Ph.D. MD, Peter R. Kowey, M.D., Dennis Roy, M.D., Jefferson L. Anderson, M.D., Eric J. Topol, M.D., and Stanley Nattel, M.D.
HUYA is the leader in U.S./China pharmaceutical co-development. With
three strategic offices in China, the broadest Chinese compound portfolio,
and more exclusive agreements with premier Chinese biotech centers than any
other company, HUYA has pioneered the most innovative and productive
approach for pharmaceutical co-development between the U.S. and China. HUYA
has joint headquarters offices in San Diego, CA, and Shanghai. Further
information about the company is available at http://www.huyabio.com.
Jan Tuttleman, PhD Wen Chen, MS, MBA
Vice President, Marketing Director of Business Development
HUYA Bioscience International, LLC HUYA Bioscience International
(858) 798-8800 86 (21) 51323312
Amy Berry Juliet Travis
(415) 793-2258 (510) 452-3771
|SOURCE HUYA Bioscience International|
Copyright©2008 PR Newswire.
All rights reserved