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Re: conf callSome additional info shared: We are currently designing a Phase 2 study of ARO-AAT that we intend to start in 2019 pending completion of chronic GLP toxicology studies, which is expected next month and pending completion of discussions with regulatory authorities on study design and endpoints. Lastly, I want to give a quick update on ARO-ANG3 and ARO-APOC3. As Chris mentioned, we already filed a CTA for ARO-ANG3 and I am pleased to report that we have the regulatory approvals necessary to begin recruiting subjects. In the first quarter of 2019, we intend to begin dosing for AROANG1001, a Phase 1 single and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of ARO-ANG3 in healthy volunteers and dyslipidemic patients. We will give more details once the study starts. For ARO-APOC3, we are working on a CTA filing now that we intend to submit in the next month. Additional details on that study will be also be available when it starts. So, first of all, with AAT, to answer that question, first, Katherine, we did six-month rat and nine-month monkey in our chronic tox studies. And in fact, that's the duration required to be able to treat for an unlimited period of time. So, we are not limited to six months or nine months of treatment. Assuming those studies are successfully reported out and acceptable to regulatory agencies, we get to treat for as long as we want. So, six months is not a limitation for us, once these studies are completed and accepted by regulatory authorities. The other part of that question, do we think six months is enough that feels pretty short to me, to be honest with you. I think in six months, it's possible that some of the changes that occur in the liver could improve, but it would be highly unlikely to see improvements in things, of course, like fibrosis. But it probably is too fast even to have very complete improvement in globules, for instance. So, I think these studies are going to have to be longer than six months to really show the benefits in the liver that we want to see. So, that's regarding AAT. |
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