Thomas Hudson
Senior Vice President R&D and Chief Scientific Officer at AbbVie
Thank you, Carrie. We have continued to make very good progress with our pipeline to start this year. In immunology, we recently received European approval for Rinvoq in Crohn's disease, making it the first JAK inhibitor approved for this indication. We continue to anticipate FDA approval for Rinvoq in Crohn's disease next month. We also recently-announced positive top-line results from our Phase-III induction study for Skyrizi in ulcerative colitis, which is a disease with unpredictable symptoms and frequent players making it challenging to manage. In our study, Skyrizi met the primary and all secondary endpoints, demonstrating a very strong impact on the disease as measured by clinical remission, clinical response and endoscopic improvement. We're particularly pleased with Skyrizi's impressive performance on the more stringent measures in this trial, with approximately 37% of Skyrizi treated patients achieving endoscopic improvement compared to 12% of patients on placebo. This level of efficacy has the potential to position Skyrizi as a highly effective therapy, and we believe it will be a welcome new treatment option for physicians and patients once approved. Detailed data from this induction study will be presented at a forthcoming medical meeting. We expect to see data from the Phase-III maintenance study in the second-quarter with our regulatory submissions planned for the second-half of the year.
In oncology, we continue to make good progress across all stages of our hematology and solid tumor pipelines. We remain on track for several important regulatory and clinical milestones this year, including regulatory approval for Epcoritamab in relapsed-refractory large B-cell lymphoma. Phase-III data from Venclexta's Canova trial in relapsed-refractory multiple myeloma patients with a T11;14 mutation and Venetoclax's Transform One trial in frontline myelofibrosis. And Phase-II data for Teliso-V in second-line plus advanced non-squamous, non-small cell lung cancer, which has the potential to support a regulatory submission for accelerated approval.
We're also beginning to see very encouraging data for our next generation CMAT ADC, which uses a more potent topo payload than our Teliso-V ADC. Based on the data, we've seen to date for ABBV-400 in our Phase-I solid tumor basket study, we plan to expand the program to earlier lines in colorectal cancer, as well as evaluate in other tumors where CMAT is expressed, including pancreatic and liver cancer.
Moving to our Neuroscience pipeline, where we've recently received FDA approval for Qulipta as a preventive treatment for patients with chronic migraine, making it the only oral CGRP antagonist approved for prevention of both episodic and chronic migraine. In our Phase-III study, Qulipta provided a significant reduction in migraine days, as well as significant improvements in function and quality of life in patients with chronic migraine, a common and debilitating disease. As a highly effective oral treatment option, we believe Qulipta will be well positioned in the chronic migraine prevention market. In Europe, we continue to anticipate an approval decision in the third-quarter for Atogepant as a preventive treatment for patients with both chronic and episodic migraine.
Turning now to ABBV-951, we announced that we received a complete response letter for our regulatory application in the US. The FDA has not asked for additional efficacy or safety studies related to our drug device delivery system, but rather they have requested additional information regarding the pump, as well as updates to instruction for use. We are working to generate the necessary information and we expect to respond to the CRL later this year, with a nifty action anticipated in the first-half of '24. In international markets, we have recently received approval for 951 in Japan, and we continue to expect approval in Europe in the fourth-quarter of this year.
In our early stage neuroscience pipeline, we recently began Phase-I studies of our selective D3 dopamine receptor agonist ABBV-932. Our experience with Vraylar has highlighted the potential clinical benefit of achieving D3 selectivity, and we believe that a compound that more selectively engages with D3 dopamine receptor has the potential to provide enhanced efficacy. Our program will initially focus on general anxiety disorder, with the potential to expand to other new psychiatric disorders.
The programs under our collaboration with Calico are also progressing well. We now have four assets in clinical trials, including two PTPN2 inhibitors in Phase-I in oncology, our eIF2B activator for neuro degenerative diseases, and an IGF1 signaling pathway modulator that will be explored in ageing-related diseases. Our most advanced program is the eIF2B activator 7262. The first patient was recently enrolled in the Healey ALS platform trial, a Phase-II, III study conducted by the Healey Center for ALS at Mass General. This trial is designed to evaluate multiple therapies simultaneously with the goal to accelerate the development of potential break-through treatments for ALS.
Now, I would like to provide a brief update on two earlier stage programs in our therapeutic pipeline. In cystic fibrosis, we recently analyzed data from an ongoing proof-of-concept study evaluating our triple combination therapy. The results from this interim analysis did not meet our criteria for advancing and we are discontinuing our cystic fibrosis program.
We also recently reviewed interim data from our exploratory studies for ABBV-154 in PMR and Crohn's disease. Similar to results from the RA study, while we observe efficacy with 154, we also observed some changes in biomarkers that are consistent with systemic steroid exposure at the higher doses. The benefit risk profile does not sufficiently differentiate 154 from other available treatments. So, based on the totality of the data across RA, PMR and Crohn's disease studies, we will not be pursuing further development of this asset.
Now, moving to our aesthetic pipeline, we recently saw data from our Phase-III studies for Botox in platysma prominence and masseter muscle prominence. In our study for prominent neck muscles, Botox met all primary and secondary endpoints, demonstrating a significant reduction in the unwanted appearance of platysma prominence on the neck and jawline. This was the first of three Phase-III studies in platysma prominence with data from the two remaining trials expected in the second-half of the year, followed by regulatory submission in the US near the end of 2023.
Botox also performed very well in our study for prominent masseter muscle, meeting the primary and all secondary endpoints in the trial. Our program is initially focused on China and other Asian markets, as masseter prominence is common in Asian populations, and there is significant unmet need for minimally-invasive treatment options. Based on the results from this trial, we expect to submit our regulatory application in China in the second-half of the year. Once approved, we anticipate high demand for Botox in this novel indication, which will help to further build our portfolio in the lower phase segment.
So, in summary, we continue to demonstrate significant progress across all stages of our pipeline and anticipate numerous important regulatory and clinical milestones throughout the remainder of 2023.
With that, I will turn the call over to Scott.
