Relivergen™ may be targeted for use in niche markets such as chronic hepatitis C (CHC). There is a major market opportunity in this sector as the current pharmaceutical therapies involve long-term treatment with expensive drugs such as interferon and ribavirin. Not only is price prohibitive for many sufferers, but the side effects are harsh and many patients fail to complete treatment. This disclosure discusses the possibilities of this specific market, as well as provides an overview of the preclinical and clinical background of Relivergen™.
Why is there a therapeutic need and a commercial opportunity for a supplement such as Relivergen™?
Over 170 million people worldwide are infected with hepatitis C. In a presentation to analysts at the 2007 meeting of the American Association for Study of Liver Diseases (AASLD) Roche predicted that the market for the treatment of chronic hepatitis C could grow from around $2.5 billion in 2006 to nearly $10 billion by 2015, mainly through the development of new antiviral therapies based on viral protease or polymerase inhibitors. It is estimated that as few as 10% of newly diagnosed chronic hepatitis C patients in the West currently go on to receive antiviral treatment, and as many as half of those who do fail therapy.
Phynova believes that this non-treatment of CHC patients and the 50% failure in treated patients represents a significant new market opportunity for a product that can relieve the symptoms of CHC and, by so doing, help improve patients’ quality of life. Phynova expects that this market opportunity will remain even as antiviral therapy improves, as the overall cure rates in hepatitis C are expected to only increase slowly over coming years. It is also expected that the new triple-antiviral therapy regimes will be expensive and not all patients may be able to benefit in the face of increased demand for treatment options. Phynova’s Relivergen™ is therefore aimed at those patients that have failed therapy and all the other patient segments comprising those individuals deferring therapy or not considered suitable for therapy.
Clinical Experience with Relivergen™
The constituent plants of Relivergen™ have a long and well-documented history of safe human usage. Relivergen™ has been evaluated in two clinical studies and was shown to be well tolerated and safe.
The component plants of Relivergen™ were selected due to their well-documented pharmacological properties. These activities include antiviral, immunomodulatory, anti-inflammatory and antifibrotic effects.
Phynova has investigated some of these activities, for example: Figure 1 shows dose dependent apoptosis of activated rat and human hepatic stellate cells by one of the Relivergen™ components (indicating a possible role in liver fibrosis abrogation or reversal)
Figure 1 Percentage apoptosis in activated HSC
A small Phase II clinical trial was conducted in the UK. The objectives of the study were to evaluate the effectiveness of Relivergen™ in alleviating the symptoms and liver inflammation associated with CHC infection and to demonstrate the clinical safety of the product.
The study was a randomised, double-blind, placebo-controlled, parallel group study in 43 patients with biopsy proven CHC, to assess the safety and tolerability and effect of Relivergen™ on fatigue and health-related quality of life (HRQoL) and liver function, over a 24 week treatment period and subsequent 4 week follow up period. The mean age of the subjects was 47 years, 25 were male and the majority had genotype 1 infection.
Relivergen™ was well tolerated and there were no treatment related adverse events throughout the period of observation. Patients receiving treatment reported that they felt physically better, more vital, alert and in general, healthier after taking Relivergen™.
Figure 2: Phase I/II clinical study. Symptom improvement on Relivergen over 6 months
In addition to the improvement in patient quality of life, there was a clear trend for the reduction in liver enzymes related to liver inflammation. Serum ALT levels of patients receiving Relivergen™ versus placebo, were lower suggesting a beneficial effect on liver inflammation. This effect was maintained from week two until at least four weeks beyond the end of treatment (Figure 3, below). There was no significant effect of active treatment on routine haematology or biochemistry.
Relivergen™ was also been evaluated in a Phase I/II double-blind, randomised, placebo-controlled safety study in the USA. The study enrolled 36 CHC patients with the primary goal of assessing product safety. Relivergen™ was shown to be well-tolerated and safe with no treatment-related adverse events.
Figure 3: ALT changes Relivergen™
Relivergen™ has granted patents relating to composition and use in several countries. |
