Medgenics (LON:MEDG, LON:MEDU, NYSE:MDGN), one of the best performing stocks of last year, has kicked off the clinical trial of its INFRADURE Biopump treatment of hepatitis C.
The first patient has signed up for the phase I/II clinical trial, which will be the first trial for INFRADURE.
INFRADURE is a skin tissue implant which provides a continuous delivery of interferon-alpha (INFa).
Medgenics is developing it to treat hepatitis B, C and D and, consistent with other applications of the company’s revolutionary Biopump platform, the idea is for a single implant to replace weeks and weeks of traditional injections.
Medgenics’ shares soared by more than 180% last year with much of the rise coming after its INFRADURE Biopump received Orphan Drug Designation from the US Food and Drug Administration (FDA).
Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process.
The Phase I/II dose-escalation study is being initiated at the Tel Aviv Sourasky medical centre in Israel, with additional sites in Israel expected to join the study.
Patients with hepatitis C of genotypes 2 and 3, who would normally receive weekly injections of pegylated INFa together with a daily dose of the oral antiviral drug ribavirin, will take part in the trial.
The study is designed to show safety and tolerability of INFRADURE through the continuous delivery of INFa into the patient's circulation and to determine effective dose levels that suppress serum levels of hepatitis C virus.
If all goes to plan, the study will assist in developing and calibrating INFRADURE for use in additional types of viral hepatitis, as well as other indications; or, as the company puts it, the study is expected to “provide a gateway to hepatitis B and D” treatments.
One of the key advantages the Biopump system has over traditional injections is the steady release of the medication, as opposed to the more traditional high concentration – or spike – followed by a decline in effectiveness that you get from old-school injections.
The steadier release through the Biopump method should reduce the potential for unpleasant side effects. These side effects pose considerable problems with patient compliance, as reflected in a therapy discontinuation rate of over 25% for traditional hepatitis C treatment.
INFRADURE is the second product based on the company's Biopump tissue-based platform to reach clinical trials in patients.
INFRADURE employs the same approach as the company's EPODURE implant producing erythropoietin, which reported months of safe and sustained treatment of anaemia from a single treatment in a Phase I/II study in patients with chronic kidney disease, replacing frequent erythropoietin injections.
An analogy of how the Biopump delivery system works might be a fire: Biopump provides the steady heat you get from charcoal briquettes, whereas a traditional injection is like throwing a ball of paper on the fire, which burns fiercely for a brief period.