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| Statement |
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| So, I think that's why that data is important for us is being able to see that there's a substantial opportunity not just from the front end, but really on this capability to transition patients to this therapy |
| So, I think we can differentiate on a whole a whole number of features, whether it's convenience, tolerability and efficacy in the right regions, I think we're in a really good position |
| Their leadership in respiratory medicine, development and commercialization makes them an ideal partner for 006 and they continue to bring substantial value to Wave through their significant investments in deep genetic insights |
| And I think what's encouraging is that modeling is sustaining in that healthy volunteer setting |
| INHBE loss-of-function heterozygous carriers identified in large genetic databases have a favorable cardiometabolic profile, including reduced abdominal obesity and reduced odds of Type 2 diabetes and coronary artery disease |
| These data give us confidence in achieving best-in-class dystrophin protein expression in our ongoing potentially registrational phase 2 clinical trial, FORWARD-53 |
| So, the update that we are sharing at MDA, which is really the ability to get into the satellite cells, stem cells and muscle that will be generating also gives us a lot in improving the regenerative potential muscles |
| Clinical data thus far for N531 positions it as potentially best in class, including industry-leading exon skipping of 53%, muscle tissue concentrations of 42,000 nanograms per gram and a half-life that supports the potential for monthly dosing |
| Our achievements demonstrate the far-reaching potential of our multimodal platform to reimagine what's possible for human health and pioneer medicines that truly change people's lives |
| Our preclinical data has well surpassed that |
| We expect meaningful catalysts throughout this year for all of these programs, setting 2024 up to be a significant year for Wave |
| This accomplishment clearly demonstrates the speed and translational power of our siRNA capability |
| As we look to the remainder of 2024, we are at a truly exciting inflection point with the opportunity to further validate our best-in-class platform in the clinic and unlock the broad potential of our pipeline |
| But I think first and foremost, we're just very excited to see the speed with which we can translate our RNA platform from a target that we introduced last year into the clinic |
| As it relates to the initial trial design, I think this is one of the advantages we have with a very potent and durable program |
| We remain on track to deliver potentially registrational 24-week expression data in the third quarter, which is positive would support our plans to file for accelerated approval in the U.S |
| In DMD, our novel chemistries have dramatically improved pharmacology of exon skipping oligonucleotides, translating to best in class muscle distribution and skipping with WVE-N531 |
| This collaboration is also expanding Wave's pipeline, as we are able to leverage GSK's genetically validated targets to advance fully owned Wave programs |
| Our goal in FORWARD-53 is to demonstrate that we can deliver endogenous functional or Becker-like dystrophin and thus provide a meaningful clinical benefit for patients amenable to exon 53 skipping |
| So, with siRNA we're able to move that template rapidly and to see that benefit |
| We have demonstrated the successful translation of our compelling preclinical data to the clinic with reduction of mutant huntingtin and preservation of wild type after a single dose in humans |
| 2023 was a year of execution and tremendous progress for Wave |
| Our net loss significantly improved over the prior year periods primarily due to the substantial revenue earned from our collaboration partners |
| So, by having in-house manufacturing, we could deliver the data pre-clinically IND enabling study material and importantly make our clinical trial material so that we could be best positioned to rapidly move to clinic |
| Having the ability to preserve this important protein is a clear advantage over pan-silencing approaches that non-selectively lower mutant and wild-type protein, especially as HD patients already start with a lower wild-type reserve |
| We were excited by the energy in the HD community and discussions around how they can advocate for accelerated registrational parts if a sponsor demonstrates supported data |
| Moving on to INHBE, we are rapidly advancing this program for the treatment of obesity and are excited to announce today that we have selected our lead clinical candidate well ahead of our prior expectations |
| 2024 should certainly be an exciting year for Wave and I look forward to the many milestones we have on the horizon |
| There is strong human genetic evidence supporting this target |
| So, I think the convergence of all of the things that we have been working on at Wave over the last decade we're really able to allow us to rapidly translate the insights from last year on the INHBE target into a potential medicine that we'll bring into the clinic in early 2025 |
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| While GLP-1s are rapidly becoming the standard-of-care for weight loss, these therapies come with several limitations, namely loss of muscle mass, poor tolerability and discontinuation rates as high as 68% |
| So, it's really a protective loss of function |
| In your in your drug, you lose weight from the fat |
| Our net loss was $16.3 million and $57.5 million for the fourth quarter and full year 2023 period respectively |
| It was actually targeted loss of fat |
| So, we're seeing weight loss coming at fat loss |
| Anne-Marie Li-Kwai-Cheung So, I think the important point to recognize is that we're not delivering exogenous AAT replacement therapy |
| Additionally, we saw decreases of lobular inflammation and reduction of liver aggregates |
| So that's important, right? That was, one, an important constraint |
| At the same time, you don't lose muscle mass |
| In fact, in preclinical studies, the majority of edits observed using DNA-based editing were bystander edits that yielded isoforms of AAT protein with lower functional activity, while indels have the potential to create loss of function variance |
| And we also have a question about the progress of the clinical study itself |
| There is an urgent need to deliver more therapeutic options to patients including achieving better access to heart and diaphragm, two areas where we have seen substantial distribution in our preclinical studies including NHP |
| It didn't correlate |
| We also observed weight loss and reduction fat mass with a preferential effect on visceral fat |
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