The race for the 2nd generation of HCV Direct Acting Antivirals continues to be too close to call, with BI's BI 210335 HCV protease inhibitor finalizing it's last patient for it's phase III trial. The asute observer of the HCV marketplace will recall the interim results of BI's SOUND-C2 trial looking at the interferon-free combo of BI 201335 and BI's BI 207127 polymerase inhibitor in genotype 1 tx-naive patients. At week 12, 76% of patients had VR with a respectable 63% of patients achieved SVR12.
From Medical News Today
Boehringer Ingelheim Completes Patient Entry For Phase III Trial Program In Hepatitis C
12 Dec 2011
According to Boehringer Ingelheim's announcement, the company's large-scale Phase III clinical trial program for BI210335, an investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV) has randomized the final patient for treatment.
Their current extensive trial program is conducted in 15 countries, with key regions in the E.U., Japan, the U.S., Canada, Korea, Taiwan and Russia at over 350 sites and involves almost 2,000 treatment-experienced and treatment-naïve patients overall.
The program's three Phase III trials will be carried out to assess BI 201335 combined with the golden standard treatment of pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. The majority of HCV patients infected with the genotype 1 virus are amongst the most difficult patient groups to treat. The study program's primary clinical endpoint is the assessment of "sustained viral response" (SVR), considered to be a viral cure, with results from the Phase III trials expected in the first half of 2013.
The complete BI 201335 program was awarded a Fast Track designation by the FDA. The U.S. Food and Drug Administration has designed the Fast Track process to enable the development and review process of important new drugs to treat serious diseases more rapidly than usual to fill an unmet medical need.
Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim said: "We are progressing our BI 201335 program with a high priority to leverage its potential to improve cure rates in HCV treatment. We believe our HCV-pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide."
Last month at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, Boehringer Ingelheim presented findings of their Phase IIb trial, which demonstrated that the interferon-free combination of BI 201335, with their polymerase inhibitor BI 207127 (SOUND-C2) resulting in 76% of patients achieving a virological response at week 12 and 63% of patients achieved SVR12, an undetectable virus 12 weeks after treatment, at week 16.
In addition to their BI 201335 results, the company also presented their SILEN-C1 and SILEN-C3 study results at the AASLD, demonstrating that BI 201335/ PegIFN/RBV's potentially shortens the time of treatment and improves the likelihood of viral cure (SVR). These Phase IIb results provide a strong case for further development, whilst BI 201335 continues its progress through Phase III.
Written by: Grace Rattue
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