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| Success in the 5-dose arm has the potential to provide welcome convenience to patients by shortening their treatment course and eliminating 3 trips to an infusion center |
| So we actually believe we will start to see a couple of people would call it a treat and retreat or it could be an induction in maintenance way and where we think we're very well positioned, both with our infused product line that will -- once it's approved, obviously, but all of the subcu, so then you put the treatment in the hands of the patient, obviously, after being diagnosed and you just have a lot more flexibility and a lot better experience for the patients who don't have to go to infusion centers to be treated |
| We've also gotten a lot of positive feedback about Horizon's recent data in chronic TED, and we see this as a win for patients suffering from chronic TED |
| I am proud of all the progress our company has made thus far and looking forward to continuing our work to bring potential best-in-class therapies to patients with thyroid eye disease and additional disease areas in the future |
| And uniformly, they're very enthusiastic about our multiple ascending dose proof-of-concept study in acute TED |
| We think that their result will play well in the marketplace with that 2-millimeter reduction and that will help them hopefully get more coverage decisions from insurance companies and with their broader label that, that will create a really nice tailwind for the market |
| So good news from the Horizon data |
| We're very pleased with what's happened in that trial |
| But I think we see there's really significant opportunity out there for market potential and to grow the market especially when we think about our 5-dose regimen that's -- as part of our THRIVE study |
| Our team has grown rapidly throughout the first quarter, and we made several key hires on our senior leadership team, helping to strategically position us for future success |
| So with regard to the THRIVE study, we're really pleased that we can announce the first placement that was enrolled back in December |
| And then with chronic, those changes that were being made, I think we should be able to return to growth either later this year or early next year and see the TEPEZZA sales pick up again |
| The chronic data that Scott just described will certainly help as far as being able to have educate and aware physicians and payers to hopefully drive additional sales in the chronic marketplace |
| We thought it was actually very good data for patients suffering from chronic TED, and there's still a very large unmet need in that population because surgical intervention is really all they have left, unless they use a systemic treatment |
| I think we've gotten a lot of positive feedback about that data |
| With our many learnings from VRDN-001 IV preclinical and clinical work, we believe that the differentiated mechanisms of action with full antagonism of IGF-1R achieved by VRDN-001 and VRDN-003 make either of them the most likely to bring a best-in-class subcutaneous product to patients |
| And I think we really have the opportunity to grow the market with our subcu offering |
| We had a productive quarter, and I'm excited to report on our progress today after completing my first 3 months as Viridian's President and CEO |
| The physicians are really excited about that, even versus the 8-dose that's already available |
| This marked the company's first presentation of VRDN-003 research at a medical congress, an exciting milestone that programs development |
| In the second half of 2022 and at the beginning of this year, we reported a series of positive topline clinical data announcements from 3 dose cohorts of the Phase I/II clinical trial, evaluating the safety and efficacy of VRDN-001 in patients with active TED |
| Based on our recent discussions with key stakeholders in the TED community, there is particular enthusiasm for our shortened 5-dose 12-week treatment regimen of VRDN-001 compared with the 8-dose 21-week regimen of FDA approved TEPEZZA |
| Those are the three criteria that we take care of near and dear and look hard to do that, and we believe this technology will help that compound that this is going to be put within our preclinical pipeline |
| They were able to post a 62% and very meaningful response with a 2-millimeter reduction in proptosis |
| We recently got some very high-level topline results from Horizon |
| All 3 candidates have the potential to be developed for delivery with a patient-friendly self-administered pen device, which could significantly increase access, reduce burden and expand treatment options for patients living with TED |
| Thanks again, and have a great evening |
| Each of these individuals have already made valuable contributions to the organization and will be integral leaders for our company as we continue to expand our teams, mature as an organization and prepare for future success |
| Finally, we continue to advance our earlier-stage preclinical pipeline and will expand our disease focus beyond TED and into the rare and autoimmune space |
| As far as things that could be potentially impacting sales or what was potentially driving a reduction from Q4 to Q1, we think as far as how Horizon was investing in the market as far as expanding their sales force the direct-to-consumer advertising as well as the patient and physician support around trying to expedite new market access and reimbursement for patients is absolutely great places to invest in |
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| But I think to your point, around potential distraction around an M&A process as that was taking place in the public headlines, certainly not helpful when you're trying to make in-flight operational changes to impact the sales trajectory of a drug |
| I think the belief is that there was a low-hanging fruit situation with the actives |
| But I'd also just point out that integration isn't easy either |
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