Micrologix acquires clinical-stage Hep C drug candidate

Micrologix Biotech, a Canadian developer of anti-infective drugs has acquired the global rights to celgosivir (MBI-3253), a Phase I/II clinical-stage compound, from Virogen (UK).

Celgosivir, which has been in over 600 subjects in human clinical studies to date, is a novel, oral antiviral agent under development for the treatment of chronic hepatitis C virus (HCV) infections.

Micrologix intends to initiate Phase II clinical development with celgosivir in 2004.

Dr Jim DeMesa, president & ceo of Micrologix said: 'This acquisition fits perfectly with our transformational and critical mass building objectives by adding a clinical stage product opportunity for chronic HCV infections.

Based on the size of recent partnerships for hepatitis products, we see MBI-3253 as a significant potential value driver for both the short and long-term. In addition to our antibacterial development programs, our product portfolio now includes candidates in both hepatitis B and hepatitis C, in various stages of development, from lead optimisation to Phase II clinical development. This positions us well to address the unmet medical need that exists globally in the area of hepatitis.'

Micrologix will pay an up-front fee in equity to Virogen and milestone payments in cash and/or equity upon the achievement of agreed upon development objectives, as well as royalties on product sales and sublicensing revenues.

Celgosivir (MBI-3253)

Celgosivir is an oral prodrug of castanospermine, a natural product derived from the Australian Black Bean chestnut tree, Castanospermum australe. It is a potent inhibitor of alpha-glucosidase, an enzyme found in mammalian cells, which affects the early stages of glycoprotein processing. HCV and other enveloped viruses require proper glycosylation of structural proteins for one or more of the following: stability, maturation, assembly and secretion of infective particles. One potential advantage of celgosivir is that it inhibits a mammalian enzyme rather than a viral target. As a result, it is less likely to lead to drug-resistant viral mutants, as is seen with conventional antiviral drugs, and has the potential to be used in combination with current HCV therapies.

Hepatitis C Virus (HCV) Chronic Infections

There are over 170m people worldwide infected with the hepatitis C virus. Chronic carriers are at risk of developing liver cirrhosis and/or liver cancer. In the United States, nearly 4m people are infected with HCV, resulting in 10,000 to 12,000 deaths annually. The number of people diagnosed with chronic HCV is expected to increase fourfold from 1990 to 2015. It is predicted that deaths from HCV will surpass those of AIDS in the US by 2010, at which time the global HCV market is forecasted to be approximately US$6bn. In the US, monotherapy with interferon-alpha and combination therapy with interferon-alpha and the ribonucleoside analog ribavirin are the two different regimens currently approved as therapy for chronic hepatitis C. Treatment with interferon-alpha alone or combination with ribavirin has limited effectiveness. The use of interferon-based therapy for the treatment of HCV can be further limited by frequent side effects, injectable administration and poor patient tolerance and adherence. Many patients receiving interferon can experience influenza-like symptoms, fatigue and depression. Ribavirin can be problematic for patients with pre-existing anemia, kidney problems or heart disease.