The study was a phase II safety, efficacy and absorption evaluation of ARYS-01 cream with the test material applied twice daily for 7 days in patients with a primary shingles episode. The results exhibited a 30% reduction in rash area in the ARYS-01 cream treatment group compared to placebo in the initial 3 days of treatment.
The active ingredient of ARYS-01 cream is sorivudine, an antiviral nucleoside analog which was originally discovered by Yamasa Corporation and is being developed as a topical formulation by Janus under a joint development agreement with Arigen of Japan. Arigen is developing ARYS-01 globally, and has several patents to cover the production method and use of the topical formulation for the treatment of shingles.
“These results provide the evidence we needed to push ahead with phase II/III trials to further validate my lifelong belief that topical ARYS-01 cream antiviral therapy can be an effective and possibly safer treatment for Herpes Zoster compared to oral antiviral therapy,” stated Haruhiko Machida, chief development officer at Arigen.
Janus Pharmaceuticals will be launching a phase II/III trial in the US in the first quarter of 2007, and is targeting the new drug application for ARYS-01 cream for early 2009.