Well, I now hand it over to Houman, Head of R&D, who will share more insights into our R&D priorities and milestones for this year. Houman?
Houman Ashrafian: Thank you, Paul. As we discussed with you in December at our R&D Day, Sanofi has delivered an unprecedented cadence of positive news and important data readouts last year across major projects with blockbuster potential. By increasing our investments in R&D, we intend to fully capitalize on growth opportunities ahead of us by prioritizing pipeline assets with meaningful growth potential and extending the opportunity to successfully launch medicines. This year, we look forward to several important regulatory milestones and readouts from our pipeline. As already mentioned by Paul, we expect regulatory milestones for Dupixent and COPD and pivotal readouts to tolebrutinib and relapsing MS and secondary progressive MS as well as rilzabrutinib in ITP.
For amlitelimab and rilzabrutinib, we’re excited to learn the outcome of important Phase 2 results in asthma later this year. Separately, we’re preparing to submit the recent positive Phase 2 results of Sarclisa in first line transplant ineligible myeloma patients for FDA approval and expect the pivotal data for subcutaneous administration before year end, which would bring additional upside for Sanofi in this large market seeking convenient treatment options. As you will recall from R&D Day, we highlighted our ambition to increase the number of Phase 3 projects by 50% across immunology, neurology and vaccines over the next two years. A significant number of these pivotal trials have already started to dose their first patients, including the first amlitelimab Phase 3 trial in AD And Phase 3 trials of frexalimab in both relapsing MS and secondary progressive MS.
We are progressing well and are evolving at the right pace as we expect to have more than 35 projects in Phase 3 by 2025. Turning to Phase 2. We are fortunate to have and initiate a significant number of projects presented at the R&D Day. One example is frexalimab in Type 1 diabetes, where we started with the study assessing different doses and routes of administration. We’re sticking to our strategy of combining strong, innovative science with opportunity to address patients’ major unmet needs. You can also see the proof points of our progress in R&D productivity by our moving our major assets such as the oral TNFR1 signaling inhibitor and lunsekimig into mid-stage. They’re both in our portfolio by providing promising solutions for multiple indications.
We believe the increased R&D investment in pivotal Phase 3 program and key Phase 2 trial will offer long term return and benefit our patients and shareholders. This is the essence of the Play-to-Win strategy. Moving on Slide 16, we provided a granular and concrete sense of areas that we are changing in Sanofi R&D recent investor events and yield. First, we talked about big investment. Through dispassionate, data driven evaluation of our pipeline, we’re investing in only our winning late stage assets to underwrite the long term growth for Sanofi. Accordingly, we’ll drive our late stage opportunity by launching multiple Phase 3 trials in parallel. We need to increase investment in these long term opportunity for us to drive real growth and value for our shareholders, and we will do that in a disciplined way.
The second theme was that we must earn the right to do that. We’re going to deliver portfolio focus across our breadth of platform sites and TAs. We continue to have the [right to win] (ph) in oncology but in a focused way. And we’re uniquely to we’re uniquely positioned to win in immunology and information. We have deep provenance in immunology, and it’s a self-fulfilling prophecy that this leads to developing better immunology drugs and also doing research in immunology. Finally, pipeline sustainability. Although we’ve made good progress to improve our R&D productivity with a focus on greater quality, we now have to step it up by leveraging both in-house research and external innovation. Slide 17. As a great example of external innovation, let me take just one minute to talk about our recently announced acquisition of Inhibrx.
It fits perfectly with our rare diseases portfolio, overlapping with our immune mediated respiratory franchise. As underlined at R&D Day, we continue to drive our successful [rare] (ph) franchise and keep our eyes open for immune mediated disease in the periphery of what we do. When it closes, this deal will add INBRX-101 to our portfolio, a recumbent human Alpha-1 antitrypsin Fc fusion protein for the treatment of Alpha-1 antitrypsin deficiency, an inherited rare disease of the lungs and liver causing progressive tissue deterioration. The Phase 1 trial showed strong data with a best-in-class profile, thanks to sustaining normal AAT levels and aiming for a better compliance due to a potential monthly dosing regimen. The current standard of care is a plasma derived AAT, leaving patients our sufficiently effective, well validated treatment.
As across our other rare disease therapies, we’re committed to patients with AATD. The next readout is expected in 2025 for a potential launch in 2027, with a potentially rapid approval following FDA Fast Track designation granted last May. The blockbuster potential behind this asset is predicated on use by both existing patients and by the anticipated use by increased number of de novo patients that could benefit from the treatment. With great pleasure, I now hand over to the GBU heads to go through their respective business performance. Over to you, Brian.
