Roopal Thakkar
Executive Vice President, Research & Development, Chief Scientific Officer at AbbVie
Thank you, Carrie. We continue to make significant progress with our R&D efforts to advance novel clinical programs across all stages of our diversified pipeline. In 2025, we expect a strong cadence of important data readouts, regulatory submissions and new approvals as well as many clinical trial starts for key programs. Starting with immunology, regulatory applications are under review for Rinvoq in GCA with approval decisions anticipated in the second-quarter. Data for two Phase-3 Rinvoq programs will be available this year, alopecia AREATA and vitiligo and for our HS and lupus programs in 2026.
Moving to Skyrizi, data from the head-to-head in psoriasis versus Sotyktu will be available this year, also this year to further support differentiation in IBD, a study comparing Skyrizi to INTIVIO in ulcerative colitis will be initiated. Additional mid-stage monotherapy and combination studies are planned in 2025, including a Phase-2 study evaluating ledicizumab in atopic dermatitis, a Phase-2 study evaluating Skyrizi and ludicizumab in psoriatic arthritis and advancement of our anti-TREM1 antibody ABB 8736 with the eventual goal to add it to the Crohn's disease platform study as a monotherapy and in combination with Skyrizi.
Moving to oncology, where multiple regulatory and clinical milestones as well as phase transitions for key programs are planned. One area that we are particularly excited about is our ADC pipeline, where several assets are aimed at multiple tumor types. Our regulatory application is under review for accelerated approval of TALISO-V as a monotherapy in patients with previously treated CMET overexpressing eGFR wild-type non-squamous non-small cell lung cancer. The target for an approval decision is in the first-half of this year. This represents a segment of lung cancer with high unmet need, where patients have limited options and tend to have a very poor prognosis. If approved, would be the first CMET directed ADC for the treatment of non-small cell lung cancer.
We are also rapidly advancing our next-gen CMET asset. A Phase-3 study evaluating ABB-400, also known as Tmab A was recently initiated in-patients with CMET overexpressed refractory metastatic colorectal cancer. Timab A as a monotherapy is being compared against chemotherapy plus bevacizumab. This year, data from a Phase-1 CRC study evaluating Timab-A in combination with bevacizumab could enable a Phase-3 study in an all-comers population. Timab A is also progressing well across lung programs. A Phase-2 study in EGFR wild-type non-small cell lung cancer is being planned where Timab A will be evaluated with a PD-1 inhibitor as a frontline combination therapy. In the eGFR mutant segment, results from the ongoing Phase-1 study could enable Timab-A dose optimization studies as a monotherapy in the second-line setting and in combination with osimertinib in the first-line setting. In gastroesophageal cancer, a Phase-2 trial was recently started evaluating TMAB-A in combination with chemotherapy and a PD-1 inhibitor in frontline patients.
We are also excited about ABB-706, an ADC that utilizes the same topal warhead and linker technology as TMAB-A, but with an antibody that targets says six. Encouraging data in small lung cancer, small-cell lung cancer were presented at ASCO last year. And this year, dose optimization and longer-term duration data will be available. This readout could lead to the initiation of a registrational study in second-line and dose optimization in combination with standard-of-care in the frontline.
Moving to FR alpha ADCs. ELAHERE is now approved for platinum-resistant ovarian cancer in the US and Europe and is currently in Phase-3 development for the platinum-sensitive ovarian cancer segment. Also, a next-generation ADC targeting FR alpha, IMGN-151 is currently in Phase-1. This year, ELAHERE will be tested in combination with bevacizumab and a PARP inhibitor. 151 is being advanced into dose optimization as well as in studies with standard-of-care agents such as bevacizumab, carboplatin and a PARP inhibitor. These mid-stage studies for ELAHERE and 151 will be used to inform our Phase-3 approach in various settings for ovarian cancer, including induction in maintenance in platinum-sensitive patients and in combination for frontline maintenance.
Another ADC from Immunogen known as targets a rare hematologic malignancy called blastic plasmacytoid dendritic cell neoplasm. Based on positive data from the pivotal Phase-2 study, a regulatory application is planned for later this year. If approved, this would be an important new treatment option for patients with this aggressive blood cancer. Also in the area of hematologic oncology, the Phase-3 MDS study is nearing completion with an overall survival data readout later this year.
Now moving to neuroscience. Following the emraclidine 1 and 2 study readouts, a thorough analysis of the data was conducted to better understand the placebo effect observed in the two trials. Our findings point to a lack of uniformity of placebo effect across sites. When assessing sites beyond those with high placebo response, a clear efficacy signal was observed, albeit more modest than reported in Phase 1b. Therefore, we see a path forward as an adjunct to atypicals in schizophrenia and as a monotherapy in psychosis related to Alzheimer's and Parkinson's. These are diseases where there is a high unmet need for safe and tolerable treatments that can provide even a modest benefit.
Additionally, our intention is to explore higher doses of emiraclidine. This is based on the degree of variability observed in the PK data from the EMPOWER studies. If higher doses are found to be safe and well-tolerated, there is a potential opportunity to evaluate emraclidine as a monotherapy in schizophrenia as higher doses may result in greater efficacy. A multiple-ascending dose study will be conducted this year and data will be available in the early part of 2026. Following this dosing work, Phase-2 studies in adjunctive schizophrenia and potentially monotherapy schizophrenia will be initiated. Dose-ranging in elderly patients is ongoing with Phase-2 studies planned in 2026 in-patients with psychosis related to Alzheimer's and Parkinson's disease.
Staying on the topic of Parkinson's disease, positive top-line results from the third Phase-3 trial for tavapadon were recently-announced. In the TEMPO-2 trial, tavapadon met the primary endpoint, demonstrating a significant reduction in the severity of Parkinson's disease symptoms compared with placebo at week 26. Key secondary endpoints were also achieved. We are very pleased with the emerging profile for tavapadon, which shows strong efficacy as a monotherapy and as an add-on to. The six-month data from the Phase-3 studies show tavapadon to be generally safe and well-tolerated with low rates of adverse events of special interest, such as sedation and impulse control disorder. Longer-term safety data will be available this year and regulatory submissions will then follow.
Moving to aesthetics, we met with the FDA late last year regarding our submission for the treatment of Lines. We are in the process of generating additional CMC data requested by the agency, which should be completed in the next few months. The regulatory submission will likely occur around the middle of the year. To summarize, there have been significant advancements across all stages of our pipeline. In 2025, we anticipate numerous important regulatory and clinical milestones, including many trial starts for key programs.
With that, I'll turn the call over to Scott.