In September, Idenix was notified by the FDA that its clinical trials were being scrutinized after its NS5B caused deaths in preclinical trials -- we're talking about rats here. So why did it take five months for the company to finally admit its failure and throw in the towel? In the misguided eyes of Idenix, all is not lost. It will partner with Janssen, a Johnson & Johnson (JNJ) company, to develop another drug for hepatitis C that is related to the faulty NS5Bs. I can only scratch my head in wonder as to how Janssen, basically a marketer of old Johnson & Johnson drugs like Procrit and Remicade, suddenly becomes a cutting-edge force in a brand new compound for an epidemic virus.
What? Idenix' lead nuc IDX184 was well into phase II studies in humans without any significant toxicity or safety issues when FDA placed the drug on clinical hold due to the problems discovered with Bristol's drug. IDX184 did not kill rats.
Idenix entered into a partnership with J&J to develop IDX719, an NS5A inhibitor, which is an entirely different class of Hep C drug.
What Medgenics will be offering the medical community is a safe, biologically engineered alternative to treating hepatitis using the highly effective interferon, only not in its over-processed pegylated form that's the cause of so many problems. Israel, which is advanced in promoting innovative therapy, moved quickly to allow Medgenics to not only conduct clinical trials of INFRADURE, but also to do them in the most efficient way possible -- smaller and quicker -- to bring the treatment to market as soon as possible.
Finally, we get to the reason for Dirks' error-strewn column. He's promoting Medgenics! I wrote about the company and its
biopump" technology last week
A phase I study of Infradure being conducted in Israel -- the technology's first experience in humans -- only began January. Medgenics has yet to obtain permission from the FDA to begin human testing of the product in the U.S.
Even if you assume generously that Medgenics' technology has merit, Infradure will be obsolete next year when interferon in any form is eliminated from the standard of care for hepatitis C. Nucs and other next-generation direct antivirals -- the drugs Dirks derides and doesn't understand -- won't require interferon to cure hepatitis C.
Dirks implies Medgenics' interferon pumps will cure hepatitis C on their own. That's nonsense. Interferon is not an effective cure for hepatitis C without additional drugs on board to assist -- ribavirin or direct-acting antivirals. Medgenics is a developing a hopelessly late, me-too version of interferon, which is why the company struggles for recognition and investor interest.
-- Reported by Adam Feuerstein in Boston.