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Phase IIb Will Be Initiated in 4Q14 Based on the Phase IIa data, Phase IIb study of ARC-520 will begin in 4Q14 that will test two dose levels in e-antigen negative anti-antigen positive patients on entecavir or tenofovir. Preparation of this Phase IIb study is underway. The Phase IIb will be a multi-dose, multi-national, and will likely include sites in the US, Europe and Asia. The Phase IIb study is designed to provide a read out on ARC-520 s ability to achieve functional cure, among other outcome measures. We estimate top line results from the Phase IIb trial will be available in mid-2015. We are pleased that the company is on track to advance ARC-520. Based on preclinical and the Phase I clinical studies, we are highly confident that the Phase IIa and Phase IIb trial will have a high possibility to be successful. We expect Arrowhead will be able to initiate pivotal Phase III trial of ARC-520 in late 2015 or early 2016, and data should be available in late 2016. NDA could be filed in 1H2017, and the FDA approval is in late 2017 or early 2018. We think ARC-520 is the primary value driver in near- and mid-term for Arrowhead. The successful development of ARC-520 is critical to Arrowhead because the HBV market offers opportunities for substantial revenues, and because validation of the Company s RNAi delivery technology opens broad opportunities both for other therapeutic programs and licensing opportunities. In this regard, the completion of the Phase I study and the initiation of the Phase IIa of ARC-520 represent an important milestone for Arrowhead in achieving its long term growth goal. One of the attractive features of RNAi and of DPCs specifically is once the safety profile in man for the delivery system has been established, additional targets and candidates can be studied rapidly. Therefore the Phase I trial of ARC-520 will provide the company with the data needed to accelerate the development of its pipeline and bring additional candidates into the clinic. |
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