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Arrowhead Cleared to Proceed with Multiple Dose Phase 2b Study of ARC-520
PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that the United States Food and Drug Administration (FDA) informed the Company that it can proceed with a multiple-dose Phase 2b clinical study of ARC-520, its clinical candidate for the treatment of chronic hepatitis B infection, under an investigational new drug (IND) application previously filed with the FDA.
"This notification from the FDA allows us to begin a multiple-dose Phase 2b study of ARC-520, and we are working diligently to get treatment sites up and running. Our goal is to gain site IRB approvals and perform site initiation visits to begin recruiting and enrolling patients for this study in about a month, " said Bruce Given, M.D., chief operating officer and head of R&D for Arrowhead. "We are also working with various regulatory agencies outside of the United States to initiate additional Phase 2b studies."
The clinical study, titled Heparc-2004, is a multicenter, randomized, double-blind, placebo-controlled, multi-dose study of ARC-520 administered intravenously to patients with chronic immune active HBV infection maintained on entecavir or tenofovir therapy. The study is planned to enroll up to 12 patients who will be randomized at a ratio of 2:1 with 8 patients receiving 1 mg/kg of ARC-520 and 4 patients receiving placebo. Each patient will receive 3 total doses, once every 4 weeks. Patients will be followed through Day 147.
The primary objective of Heparc-2004 is to evaluate the depth of hepatitis B surface antigen (HBsAg) decline in response to multiple doses of ARC-520 compared to placebo in patients with chronic, immune active HBV infection as a measure of drug activity. Secondary objectives are to measure safety and tolerability and pharmacokinetics of ARC-520, and to evaluate the effect of ARC-520 on entecavir or tenofovir pharmacokinetics, in addition to other exploratory safety and pharmacodynamic objectives.
In connection with an IND filed in December 2014, Arrowhead proposed a parallel design multiple-dose Phase 2b study testing doses of 2 mg/kg and 4 mg/kg simultaneously. In January 2015, the FDA notified the Company that a partial clinical hold had been placed on the program. In order to proceed with the proposed parallel design study, the FDA requested that the Company provide additional information including data from the single-dose Phase 2a study in patients who receive 1-4 mg/kg ARC-520, data from an ongoing multiple-dose non-clinical study, and data from Heparc-2004 which is now cleared to begin. |
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楼主: 林伍伍
发表于 2015-4-13 19:54
