Recently ZymoGenetics, Inc. (ZGEN) announced the commencement of the second part of a mid-stage study (EMERGE) involving its PEG-Interferon lambda (formerly known as IL-29) and ribavirin in treatment-naïve patients suffering from chronic hepatitis C virus (HCV) infection.
As a reminder, on Jan 12, 2009, ZymoGenetics and Bristol-Myers Squibb Co. (BMY) entered into a global collaboration for developing PEG-Interferon lambda. PEG-Interferon lambda is a novel type III interferon. The native human protein Interferon lambda is generated by the immune system in response to viral infection.
PEG-Interferon lambda can be differentiated from available interferon therapy since it mediates anti-viral activity through a receptor. The receptor is distinct from that used by Interferon alpha and is present in fewer cell types within the tissues of the body. Consequently, the possibility for more targeted delivery of interferon therapy and an improved therapeutic index prevails.
The first part of the international, randomized multi-center mid-stage study is ongoing and is evaluating a range of four doses. The second portion of the mid-stage study will involve the three highest doses of PEG-Interferon lambda namely 120 mcg, 180 mcg and 240 mcg. The study is designed to evaluate the safety and antiviral efficacy of the three specified doses of PEG-Interferon lambda compared to Roche’s (RHHBY) Pegasys.
The company intends to enroll approximately 600 patients with genotypes 1 – 4 chronic HCV infection for this portion of the study. The proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of treatment constitute the primary endpoint of the trial.
The strength of each cohort will be approximately 150. Furthermore, it will include at least 100 genotype 1 patients. Genotype 1 or 4 patients will be administered weekly subcutaneous doses of PEG-Interferon lambda or Pegasys for 48 weeks. Genotype 2 or 3 patients will be administered the same for half that time period. All patients enrolled in the study will receive ribavirin on a daily basis.
The HCV market is lucrative with a huge unmet need. Chronic HCV infection is a leading cause of cirrhosis, liver failure and hepatocellular carcinoma across the globe. It is estimated that HCV is associated with up to 20,000 deaths annually in the US. Furthermore, HCV is the main reason behind liver transplantation. HCV affects approximately 4 million people in the US and 11 million people globally.
ZymoGenetics, headquartered in Seattle, WA, focuses on the discovery, development and commercialization of therapeutic proteins for disease prevention.
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