LONDON, UK (GlobalData), 2 August 2012 - On July 30th, Vertex Pharmaceuticals released a statement highlighting positive results from their initial Phase I trials testing the hepatitis C virus (HCV) therapy, ALS-2200. HCV currently infects about 3% of the world’s population, and as many as eleven genotypic strains have been identified worldwide. Genotype 1 HCV has been implicated in most chronic HCV infections and poses a significant healthcare concern. ALS-2200, a nucleotide analogue therapy, was administered to eight individuals suffering from chronic viral infection by HCV genotype 1, and all patients registered significant decreases in viral RNA after treatment. Patients were provided a daily dose of 220mg of ALS-2200 over a period of a week. The study also showed that viral loads were decreased as early as three days after dosing and effects were sustained for two days after the completion of the regimen.
Vertex is not new to the HCV market and currently produces telaprevir-based therapy (marketed as Incivek, Incivo and Telavic) to treat HCV infection. While telaprevir is a protease inhibitor, i.e., it inhibits HCV protease activity and thereby replication, ALS-2200 is a nucleotide analogue that inhibits replication by targeting the NS5B polymerase. ALS-2200 was in-licensed from Alios BioPharma in 2011 and represents a new strategy by Vertex to participate in the nucleotide analogue HCV market.
Drugs containing agents such as Vertex’s telaprevir are indicated for use in combinatorial treatments with pegylated interferon and ribavirin, which have sub-par safety profiles and can cause life-threatening side effects. HCV currently has no cure, but patients suffering from chronic infections are generally treated with interferon, combinatorial interferon therapy with ribavirin or pegylated interferon with ribavirin. The efficacy of these treatments varies due to the host response or the genotypic variant of the virus causing the infection. More recently, many pharmaceutical manufacturers and scientists have proposed the use of direct-acting antiviral (DAA) drugs, such as the nucleotide analogue treatment ALS-2200, as an alternative to dealing with escalating adverse effects from using current interferon and ribavirin therapies.
Vertex also stated plans to test ALS-2200 in combination with Incivek or ribavirin in patients infected with genotype 1 HCV to investigate the likelihood of a stronger therapeutic response in the infected patient. Robert Kauffman, MD PhD, the Senior Vice President and Chief Medical Officer at Vertex, stated that Vertex would move rapidly towards Phase II trials for ALS-2200 within the year, while actively pursuing combinatorial approaches for treatment.
Vertex also released a financial report stating that the company is seeking to increase the indicated use of Incivek to include more patients such as those affected by comorbidities, e.g. HIV or recent liver transplant recipients suffering from repeat infections. Furthermore, Vertex is also seeking to alter the dosing regimen from three times a day to twice a day, which may increase patient compliance.
With Vertex’s statements, the company will be making strides to garner an even larger share of the current HCV market. However, they might face stiff competition. As reported by GlobalData earlier this week (Idenix Pharmaceutical Zips into the Fast Track with New Hepititis C Virus Therapy), Idenix was granted an FDA Fast-Track designation for a promising pan-genotypic anti-HCV therapy, IDX719. This validates a large unmet need in the market today, i.e., a therapy capable of treating multiple genotypes of HCV. In comparison, the clinical trial strategy being used by Vertex would appear to indicate that the company weighs in favor of the combinatorial therapy approach, despite the concerns linked to poor safety profiles of these drugs. While Vertex would prefer not to cannibalize its sales of Incivek in favor of ALS-2200, one would have to consider the perceived financial benefit that can be realized from the introduction of a game-changing DAA, such as ALS-220.
Idenix’s pipeline includes a drug currently in Phase II trials that also targets genotype 1 HCV, suggesting that most companies still view genotype 1 as the primary market segment for any new HCV therapy. As this race escalates, Vertex will encounter other hard-hitting pharma players, such as Gilead, which currently also has drugs in trials that will adopt a pan-genotypic approach to treatment. Vertex may consider in-licensing Idenix’s HCV pipeline, but will have to be prepared to pay top-dollar to increase its arsenal by bolstering its pipeline.
*With the Threat of Competition Looming, Vertex Boasts of Promising New HCV Therapy
This expert insight was written by GlobalData's senior healthcare analyst for infectious diseases, Dr. Ramya Kartikeyan. If you would like an analyst comment or to arrange an interview, please contact us on the details below.
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