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| And we believe that ACU193's high selectivity for toxic amyloid beta oligomers may lead to differentiation via increased clinical efficacy and improved safety and convenience as compared to approved and under-reviewed antibodies |
| So we looked at it as a really positive result |
| Today, I'm pleased to share positive results for ACU193 on CSF biomarkers that further reinforce downstream pharmacology in addition to the previously presented target engagement and amyloid PET data for ACU193 |
| Our positive Phase I top-line results enabled us to demonstrate convincing proof of mechanism for ACU193, further supported by the CSF biomarker data share today |
| In terms of feedback that we had at CTAD interacting with the site investigators and others in the field, there was a strong demand and interest in participating in the study |
| We are very excited about our recently signed global collaboration and licensing agreement with Halozyme |
| So from that standpoint, I think it's good |
| Today, we have positive updates to share regarding the CSF biomarkers from our Phase I study, our recent FDA interaction and the newly announced development partnership and financing to pursue a subcutaneous form of ACU193 |
| With regard to the tau, yes, we -- those were fairly impressive results after just three administrations drug |
| Overall, we continue to be very pleased with the quality of the data generated in our INTERCEPT-AD Phase I trial and the corresponding insights that have helped to guide the design of our Phase II study such as our compelling target engagement, amyloid plaque reduction, and now, CSF biomarker effects |
| And the additional financing to support subcutaneous development provides the capital to support the focus of our talented team, working to solidify AC193's potential as a future differentiated and potential best-in-class option for early Alzheimer's treatment |
| So I will emphasize that we are committed to executing on the promise of the A-beta oligomer theory hypothesis, and the potential for ACU193 to be a best-in-class therapeutic option for Alzheimer's patients and their families |
| So we're optimistic that the interest in participating in research, and particularly with respect to 193, is we're in a good moment of time for that |
| This is encouraging because it further supports that ACU193's mechanism may lead to clinical efficacy, given p-tau's established relationship with cognitive decline |
| But really in spinal fluid, going up is a good thing |
| We have made significant regulatory, operational and strategic progress to this end, supported by the deep Alzheimer's development expertise of our team |
| So not having that as a liability would be really clinically, I think, a really major benefit |
| We have been very productive since our last quarterly update, and I'm pleased to have data to share with you today regarding the CSF biomarker changes we have measured in our Phase I INTERCEPT-AD study |
| The bottom line is that because of our robust Phase I results, we have been able to choose two Phase II study active dose arms that could both be potentially efficacious and reduced cognitive decline |
| It was a good change |
| So as we mentioned, we had a favorable interaction recently with the FDA on the Phase II/III design |
| Our partnership with Halozyme show the development of a subcutaneous option of ACU193 extends its product profile in pursuit of greater patient choice and convenience |
| We received encouraging feedback from the FDA on the line of our next phase of clinical development, which we are operationalizing as we speak |
| This October, we presented a deeper dive into our Phase I results at the Clinical Trials for Alzheimer's Disease Medium or CTAD, which was very well received by the medical community |
| Eliminating that risk factor would obviously be really beneficial in the clinic because now there's some recommendations that people be tested for their APOE carrier status before you begin treatment |
| We recognize the attractiveness of this mode of administration to offer additional flexibility and convenience for patients and caregivers |
| In other words, on the basis of the Phase I data and subsequent PK/PD modeling, we have confidence that at both these doses of ACU193, we'll adequately saturate our intended target, toxic A-beta oligomers in the brain |
| Based on our dose modeling, we believe there is a potential for competitive commercial product profile of a subcutaneous dosage form of ACU193, which may ultimately be commercialized alongside every four-week IV ACU193 to potentially broaden treatment options for patients |
| While not conclusive, these analyses support the concept that ACU193 binding to A-beta oligomers, rather than plaque reduction, mediates its downstream pharmacology and potential clinical benefits |
| I'd also like to highlight that our symposium presentation at CTAD was well received by the medical community, as Dan mentioned |
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| This led to a loss from operations of $16 million in the quarter |
| For the 25 milligrams per kilogram every two weeks cohort, all eight people on treatment had a decline in Centiloids values |
| For the 60 milligrams per kilogram cohort, seven of eight patients had a decline in Centiloids |
| So we tend to think of A-beta 42 being a bad thing |
| Please see Slide 2 of the accompanying presentation, a press release issued this morning and our most recent annual and quarterly reports filed with the SEC for important risk factors that could cause our actual results to differ materially from those expressed or implied in the forward-looking statements |
| And that just turned out not to be the case |
| It's really difficult, at least for me to interpret those data |
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