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| Statement |
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| From our perspective, right, tau is an excellent target in Alzheimer's |
| But I think what's really important is that it's a very exciting program because we saw really statistically significant differences in Part A and Part B |
| We also think that CLE is a really important opportunity |
| And we saw encouraging results in that population |
| We also think that we have a significant opportunity in lupus, where we've got multiple programs in SLE and CLE with the potential to contribute to revenue in the back half of the decade |
| So overall, we are excited about these programs |
| We are very excited |
| And here, I would say, it's not just in the disease area but it's also to leverage the tools that we believe we've been quite successful in, for example, with advancing amyloid, as a surrogate biomark or we believe we pioneered that within Alzheimer's disease |
| That's an excellent overview |
| I believe that we've made significant progress over the last year bringing about kind of a new Biogen as we prioritize our pipeline to invest really where we believe we can deliver the greatest return and enhance value |
| But we're excited about the pathway |
| Excellent |
| But we are very encouraged with where we are |
| And although this endpoint wasn't met, we saw that dapi was very generally well-tolerated and demonstrated separation -- significant separation versus placebo on multiple clinical and immunological parameters, so higher proportion of patients with BICLA responders, higher proportions of patients with anti-dsDNA titers lowering as well as complement level lowering as early as week eight |
| So that all looks great |
| We've also completed the Reata acquisition, and we realigned the company's structure and overall cost basis to support the best future growth |
| We are also continuing to expand our leadership in Alzheimer's disease with advancing assets targeting Tau, and we believe that Tau could represent yet another aspect of the future of Alzheimer's disease |
| So establishing it now and continuing to build on the foundation, hopefully, we will see success and optimism at the end of the AHEAD 3-45 trial |
| So we believe that this is differentiated |
| So we think it's a very important candidate |
| So we're looking at what is our expertise, what's the domain, for example, in neurology or immunology that we're really good at and bringing it all together |
| It's a very important inflection point for us this year |
| There's a lot we believe to be excited about in the Biogen pipeline, and there are a number of inflection points this year that we can speak about during the session |
| That's great |
| I work very closely with the Head of Research, the Head of Corporate Strategy, and we think there's a lot more potential to expand beyond neurology into immunology and the rare disease space |
| So we believe they're going to be very important |
| But when I look at the data that we generated at six months and the patients' unmet need and the importance of this formulation, I think we are going to see progress as we continue to move forward |
| That would be a very good place to land for subcutaneous formulation |
| But we saw a very important difference there |
| So we'll be kind of coming up with the holistic criteria that help us get confident that we're seeing the change |
| Statement |
|---|
| And EEG data that Ionis has put out a press release early toward a trend, towards slowing of delta wave activity |
| And therefore, there's an impairment of the synaptic connections and brain network activity, which you can see would result in all the symptoms that I described |
| And almost all patients -- this is, of course, a small study, but almost all patients, the neurofilament levels went down significantly |
| We knew about all the logistical impediments |
| While they can be difficult in the beginning, we've seen several centers, several individual neurologists overcome that hurdle |
| I think other people have been surprised, too |
| But age-related older mice or cognitive deficits have been reported in some models, suggesting that complete tau knockout on motor and cognitive functions in animals is inconsistent and inconclusive |
| They are unable to live independently, which naturally in cases they're a huge burden on families, caregivers and society and, of course, the patients |
| We also saw a reduction from all areas of the brain |
| I think I've been really surprised by the pace of the launch |
| I think the risk here isn't really about the pathway |
| The second point I think here that's important is we have not seen safety signals with BIIB121 |
| This is a normal individual, leading to expression of only the maternal allele, whereas in Angelman syndrome, that maternal allele is either absent or is inactivated through genetic mutation leading to a loss of the UBE3A gene expression |
| Because really the problem that we're seeing right now, the bottleneck is getting access to a neurologist |
| It's because of the lack of multiplicity control and consistent with standards that -- and it was a secondary endpoint |
| But it didn't hit -- it didn't meet its primary endpoint in Phase II |
| But we believe that this has ramification beyond |
| And we've seen that pharmacological down-regulation of tau in an adult may not have the same effect on a potential safety state as a long -- lifelong genetic loss of function of tau |
| In SLE, there continues to be a high unmet need |
| So we don't see it as a major stumbling block |
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