Tibotec, a pharmaceutical research and development company focusing on innovative treatments for infectious diseases, is using its virology expertise to introduce novel antiviral therapies to treat chronic hepatitis C (HCV). Through a collaboration with Vertex Pharmaceuticals, Tibotec is developing an investigational protease inhibitor (PI) telaprevir, a new specifically targeted antiviral therapy for hepatitis C (STAT-C) to be studied in HCV genotype 1 patients who have failed prior treatment with standard of care, as well as in those who have never been treated. Tibotec is also collaborating with Medivir on the development of a second generation investigational PI, TMC435, for the treatment of HCV. Data on both compounds will be presented at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark, 22-26, April 2009.

Telaprevir data at EASL will include a late breaker oral presentation of the final results from the phase 2 clinical trial known as PROVE 3, which was conducted in HCV genotype 1-infected patients who did not respond to a prior course of therapy with current standard of care (including both non-responders and relapsers). Two additional abstracts with phase 2a data on telaprevir in treatment-naïve patients with genotypes 2, 3 and 4 will also be presented. Data presented at EASL on TMC435 will include an oral and a late-breaker poster presentation of the four-week data from the phase 2 clinical trial known as OPERA-1, which was conducted in genotype 1-infected treatment-naïve and treatment-experienced patients.

"Through our work in HIV, we were able to contribute to the fight against infectious disease and change people's lives," said Roger Pomerantz, MD, President of Tibotec Research and Development. "Now we are applying our expertise in virology toward the development of new antivirals for the treatment of HCV."

To date, Tibotec has brought to market two anti-HIV medications, including a protease inhibitor for treatment-naïve and -experienced patients, and the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in NNRTI-resistant patients, both for use as part of HIV combination therapy. Its pipeline comprises additional treatments for HIV, tuberculosis, and HCV.

Telaprevir Presentations at EASL

Data from three abstracts on telaprevir, including one late-breaker will be presented in oral presentations at EASL.

1. "Results of a Proof of Concept Study (C210) of Telaprevir Monotherapy and in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Genotype 4 HCV Patients"; 23 April 2009, 5:45 - 6:00PM CET, Oral Presentation

2. "Activity of Telaprevir Alone or in Combination with Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Genotype 2 and 3 Hepatitis-C Patients: Interim Results of Study C209"; 24 April 2009, 11:45AM - 12:00PM CET, Oral Presentation

3. "Telaprevir in Hepatitis C Genotype-1-Infected Patients with Prior Non-Response, Viral Breakthrough or Relapse to Peginterferon-alfa-2a/b and Ribavirin Therapy: SVR Results of the PROVE 3 Study"; 25 April 2009, 5:00 - 5:15PM CET, Late-Breaker Oral Presentation

TMC435 Presentations at EASL

Data from two abstracts on TMC435, including one oral presentation and one late-breaker poster will be presented at EASL.

1. "OPERA-1 trial: interim analysis of safety and antiviral activity of TMC435 in treatment-naïve genotype 1 HCV patients"; 23 April 2009, 6:00 - 6:15PM CET, Oral Presentation

2. "Antiviral activity and safety of TMC435 combined with Peginterferon Alfa-2a and Ribavirin in patients with genotype 1 Hepatitis C infection who failed previous IFN-based therapy"; 23-25 April 2009, 8:00AM- 8:30PM CET, Late-Breaker Poster Presentation

About Telaprevir

There are currently two fully enrolled, pivotal phase 3 clinical trials examining telaprevir in genotype 1 HCV-infected adults - REALIZE in treatment-experienced patients and ADVANCE in treatment-naïve patients. REALIZE is the only ongoing phase 3 study comparing the efficacy of a regimen containing a STAT-C to current standard of care in null responders, while ADVANCE is evaluating the potential for a 24-week duration of therapy in treatment-naïve HCV genotype 1 patients. A third phase 3 study, ILLUMINATE, will provide additional data on telaprevir in treatment-naïve patients.

Tibotec has the right to develop and commercialise telaprevir in Europe, South America, the Middle East, Africa, India, Australia and New Zealand; Vertex will commercialise telaprevir in the U.S., Canada, Mexico and the Far East.

About TMC435

The protease inhibitor TMC435, which is currently being evaluated in phase 2 trials, is the first outcome of a drug discovery collaboration between Tibotec and Medivir. Tibotec has the right to commercialise the compound throughout the world, excluding the Nordic countries.

About HCV

With an estimated 170 million people infected worldwide and three to four million people newly infected each year, HCV poses a significant burden on patients and society[i]. Chronic infection with HCV, a blood-borne infectious disease that affects the liver, can lead to liver cancer and other serious and fatal liver diseases, and is the most common cause of liver transplant in Europe[ii][iii]. The current standard of care for HCV patients, treatment with pegylated interferon combined with ribavirin[iv], cures 40 to 50 percent of G1 patients and has an unfavourable side effect profile[v]. The development of new therapies, particularly direct antivirals with different modes of action, will allow HCV patients to undergo a more effective treatment regimen6.

Reference

[i] The World Health Organization (WHO), Hepatitis C Factsheet (WHO Media Center, October 2000), pg. 1, para. 2.

[ii] Samuel D and Roche B, Risk Factors for Hepatitis C Recurrence After Liver Transplantation (Journal of Viral Hepatitis, November 2007), pg. 1, para. 1.

[iii] Centers for Disease Control, The ABCs of Hepatitis (CDC), table 1, col. 4.

[iv] The World Health Organization (WHO), Hepatitis C Factsheet (WHO Media Center, October 2000), pg. 3, para. 4.

[v] Michael P. Manns, Graham R. Foster, Jürgen K. Rockstroh, Stefan Zeuzem, Fabien Zoulim and Michael Houghton, The Way Forward in HCV Treatment-Finding the Right Path (Nature Publishing Group, December 2007), pg. 2, col. 2, para. 2 and 5.

[vi] Sagir A, Heintges T, Akyazi Z, Oette M, Erhardt A, and Häussinger D, Relapse to prior therapy is the most important factor for the retreatment response in patients with chronic hepatitis C virus infection (University of Dusseldorf, September 2007), pg. 1, para. 1.

Source
Tibotec BVBA