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| Statement |
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| So myostatin is a very good target |
| We've made excellent progress so far this year and in particular, in the third quarter, and I'm very excited about our future and believe we are well positioned for success |
| With the capital enhance, promising programs underway and our strategic imperatives aligned with our core competency, unparalleled selectivity of myostatin inhibition, we are excited about the future and our ability to serve patients with our important novel therapies |
| So, again, so a lot of questions to address in the clinical program, which is exciting for me, but I'm really excited by the fact that Mo and Mo's team have 439 that they've moved since I joined the company to now talking about moving toward IND, really good progress from our research team |
| It has attractive property |
| Safety is critically important in treating SMA and in weight loss therapy, and we believe our selective approach, as we've seen with apitegromab in our SMA program to-date, should lead to a favorable overall benefit risk profile |
| 2023 has been a year of significant execution across our portfolio, and we're well positioned going into 2024 |
| It is worth noting that we see lean mass reservation with doses as low as 0.3 milligram per kilogram of call SRK-439, which highlights the favorable profile of SRK-439 for development in this indication |
| I'm very pleased with the significant progress that we've made on our pipeline since the beginning of the year |
| We're focused on advancing the myostatin programs, SMA and cardiometabolic Additionally, we believe we're well positioned to bring in nondilutive funding as we continue to evaluate potential partnership opportunities for other programs within our portfolio |
| So I think we're well positioned to – to replicate in SAPPHIRE what we saw in the TOPAZ study |
| Again, just to reinforce, I'm really delighted with the work our team has done, very pleased with our progress, and I really look forward to kind of driving through the rest of this year and really running into 2024, where we have some really major milestones |
| Importantly, Onex provides an opportunity to further strengthen the body of evidence on long-term safety and efficacy |
| Why I'm really delighted that we have the opportunity to proof-of-concept with apitegromab is because it's already a clinical-stage asset |
| Our upsized public offering that we completed last month puts us in a strong financial position with our cash runway that extends into the second half of 2025 |
| SRK-439 has attractive properties and potential to address the muscle loss associated with weight loss |
| We're seeing great productivity coming out of our scientific platform as our unique approach of targeting the latent form of growth factors to achieve exquisite selectivity appears to be proving patient outcomes in SMA and in oncology |
| As shown, there was robust, consistent and sustained improvement in the motor function scales, the extended Hammersmith and The Revised Upper Limb Module, which are also the primary and secondary endpoints in SAPPHIRE as well as improvements in the patient reported outcome measures, as reflected in an increase in activities of daily living and reduction in fatigue all measures that are consistent with improvement in muscle strength |
| Turning to Slide 14, I'm very pleased with the progress we've made this year toward executing on the promise of apitegromab in SMA |
| And as Ted said, right now for us today, really pleased with the way Dragon performed |
| We are excited to be applying this selectivity to our cardiometabolic disease areas where we believe safety is so important, and our approach is highly differentiated |
| The team made excellent progress with the DRAGON study since the start of the year, culminating in two poster presentations at the Annual Meeting of the Society for Immunotherapy of Cancer, this past weekend |
| So that's a good thing |
| It also maintains a good developability profile, and is amenable to subcutaneous formulation and dosing |
| We'll obviously see that when we report on our Phase III data, but so far -- and we're seeing that in TOPAZ, we have patients coming on four years with really a very, very clean safety profile |
| I was very excited to announce that we are leveraging our R&D platform and deep knowledge of myostatin biology to expand into a new therapeutic area of cardiometabolic disorders with our novel, highly potent and selective anti-myostatin antibody SRK-439 in combination with the GLP-1 receptor agonist |
| And finally, our team is in the planning stages for additional follow-on SMA studies, including in children under the age of two, and in ambulatory patients, allowing us to extend the potential benefit of apitegromab to the broadest patient population possible |
| And I think we're positioned to show that |
| We're really at the beginning of this effort -- beginning of the effort of kind of mapping out the full clinical program to registration, but not at the beginning efforts of our deep thinking around myostatin and targeting this space, right? So, we've got a lot of good ideas, more to come, but I think we can do that |
| With respect to safety, the combination was generally well tolerated with the most common Treatment Emergent Adverse Events, predominantly skin toxicities, of rash and pruritus |
| Statement |
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| Semaglutide did lead to significant loss of lead mass in addition to fat mass loss as seen in the TAM bar |
| If you look at what happens when you hit active and receptors A and B, you start to get into some things that you may not want to see, right, that over time could potentially be troublesome and that's also true with GDF11 |
| As you know, I think there is a challenge with maintaining therapy on the current GLP-1 receptor agonist |
| Hope that data is really underscoring that |
| For 181, you know, the data that I shared on the way I try to put the color on it, this is really a tough group to treat |
| For example, inhibition of the closely related GDF11 growth factor signaling may have negative impacts on bone an inhibition of activins has demonstrated effects on reproductive biology likely limiting the use of products, which target this pathway in women of child-bearing age |
| So I think there's a lot of things that affect the overall waive loss |
| Are some of the treatment-emergent events more worrisome in the context of the combination? Thank you very much |
| We're seeing some effects, but nothing like what we've seen in the past that would really warrant stopping these therapies |
| When the SMN protein is deficient, the motor neuron degenerates resulting in muscle weakness in atrophy, leading to significant impairments, including the inability to sit, stand and walk depending on the extent of involvement |
| I think about weight loss therapies over time, they've been effective, but they've all been troubled by toxicities and safety issues that have prevented their continued use |
| However, when combined with SRK-439, the loss in lean mass induced by semaglutide alone was dose-dependently reversed, leading to maintenance of lean mass while enhancing fat mass loss |
| Please refer to our SEC filings for the full disclosure of all the risks |
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