SHR-1905

GSK is looking to expand its COPD biologics franchise beyond IL-5 blockade, kicking off two Phase III studies of its long-acting anti-TSLP antibody felcorekibart (GSK5784283/AIO-001). Sanofi and Regeneron's IL-4/IL-13 inhibitor Dupixent (dupilumab) and GSK's IL-5 inhibitor Nucala (mepolizumab) are currently the only approved biologics for the condition. Earlier this year, CEO Luke Miels singled out felcorekibart as one of the pipeline programmes that could help GSK raise its game (see – Spotlight On: GSK's new CEO urges company to deliver 'more competitive products'). The programme, acquired through GSK's 2024 takeout of Aiolos Bio for $1 billion upfront, will be tested in the PERSIST COPD-1 and PERSIST COPD-2 studies. Each will enrol 624 patients with moderate to very severe COPD to assess whether felcorekibart, added to standard therapy, can cut the annualised rate of moderate and severe exacerbations, according to ClinicalTrials.gov. Primary completion is targeted for mid 2029. GSK is also starting PERSIST ASTHMA-1, a 514-patient Phase III study of felcorekibart in patients with uncontrolled asthma. Three more late-stage studies of the drug are expected to begin this half as well (see – Vital Signs: GSK management comes out swinging with pipeline refresh). The COPD programme puts GSK in the race with other companies that are looking to make TSLP blockade a new treatment option against the respiratory disease. AstraZeneca and Amgen are testing the first approved TSLP-targeting drug Tezspire (tezepelumab) – it was originally cleared in 2021 for severe asthma followed by a label extension into chronic rhinosinusitis with nasal polyps last year – in the Phase III EMBARK and JOURNEY studies, each enrolling 990 patients with moderate to very severe COPD. Both trials are expected to report in early 2029. However, according to a recent FirstWord report, Tezspire's prospects as a potential therapy for patients with non-eosinophilic COPD were clouded following disappointing results from the Phase II COURSE study last year, which raised questions about the breadth of its potential benefit (see – KOL Views Q&A: Breadth of Tezspire's activity could be key asset in COPD battle with Dupixent). EMBARK and JOURNEY are evaluating Tezspire in a refined eosinophilic patient population. "The initial thinking with tezepelumab was that because it targets early in the inflammatory cascade it may affect type 1 inflammation, which it does marginally. That makes it interesting, and so, certainly, I would like to see further development of it," one key opinion leader (KOL) told FirstWord (see – KOL Insight: Chronic Obstructive Pulmonary Disease). "However, a lot of the Phase II COURSE study wasn't positive." Another said, "The last thing we need is another type 2 eosinophilic biologic in COPD. It's a disappointment because Tezspire could really help us with the non-eosinophilic patients, which are at least 70% of the [COPD] population." Meanwhile, Sanofi is pursuing a potentially differentiated TSLP strategy with lunsekimig, a bispecific antibody targeting both TSLP and IL-13. KOLs told FirstWord that honing and clearly defining the patient population responsive to lunsekimig – aiming for a niche distinct from Dupixent and Nucala – would be a strategy for success. The drug is currently being evaluated in the Phase IIb/III PERSEPHONE and THESEUS studies, each enrolling 942 patients with inadequately controlled COPD and an eosinophilic phenotype. The content above comes from the network. if any infringement, please contact us to modify.

Amgen and AstraZeneca’s inflammatory disease drug Tezspire has clinched a phase 3 win in eosinophilic esophagitis (EoE) as the partners eye another challenge to Sanofi and Regeneron’s incumbent Dupixent. A phase 3 EoE trial for Tezspire has hit all primary and key secondary endpoints, Amgen and AZ announced Thursday. By targeting an upstream driver of inflammation, Tezspire demonstrated statistically significant improvements in both histologic remission—defined by a low count of peak eosinophils in the esophagus—and swallowing difficulties compared to placebo at week 24, according to the companies. For both Tezspire doses tested, the treatment effects on the study’s co-primary endpoints lasted through week 52, the companies added. The success from the phase 3 Crossing trial positions the anti-TSLP biologic to potentially expand into its third inflammatory disease indication beyond severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Amgen and AZ said they will share the study’s results with regulatory authorities and with the scientific community at an upcoming medical meeting. If approved, Tezspire would open a new front in its rivalry with Dupixent, which became the first medicine specifically indicated for EoE in 2022. Compared with Tezspire’s upstream targeting of TSLP, Dupixent works downstream in the immune cascade by blocking IL-4 and IL-13 signaling pathways. EoE is a chronic inflammatory disease of the esophagus, which can lead to esophageal narrowing and difficulty swallowing, known as dysphagia. The disorder is estimated to affect more than 470,000 people in the U.S., with increased prevalence in the past few years, according to Amgen and AZ. Before biologics are introduced, first-line treatment of EoE typically centers on three methods, frequently referred to as the “3Ds”—drugs, diet and dilation. For drugs, proton pump inhibitors such as omeprazole and swallowed topical corticosteroids like fluticasone are common options. During the Crossing trial, patients were allowed to remain on those background medications. “Despite the availability of first-line therapies or dietary interventions, many patients with eosinophilic esophagitis still experience substantial burden, including difficulty swallowing food, and emotional and daily-life impacts of the disease,” Arjan Bredenoord, M.D., a gastroenterologist at the Amsterdam University Medical Center in the Netherlands and primary investigator of the Crossing trial, said in an Aug. 27 statement. “The impressive results from the Crossing trial sustained over 52 weeks demonstrate that [Tezspire], taken every four weeks, could provide a new approach to treating this disease, with the potential to help more patients achieve remission and symptom improvement,” he added. In addition to the primary endpoints measured at week 24 and the key secondary endpoints evaluated at week 52, Crossing also hit other goals, including endoscopic disease features and histologic severity and extent at weeks 24 and 52, plus endoscopic response, inflammatory remission and total endoscopic remission at week 52. Tezspire’s trial win now gives AZ another shot at EoE after its anti-IL5 antibody Fasenra failed to make the cut. Back in 2022, the British pharma reported mixed results from the phase 3 Messina trial, in which Fasenra achieved better histological disease remission compared to placebo but came up short on the dysphagia symptoms metric. Besides EoE, Tezspire is undergoing phase 3 development—the Journey and Embark trials—in chronic obstructive pulmonary disease (COPD). First approved by the FDA for severe asthma in late 2021, Tezspire generated $1.9 billion in combined sales for Amgen and AZ in 2025, up from nearly $1.3 billion the year before. With a much broader label beyond inflammatory conditions affecting the airway, Dupixent brought in $17.8 billion in 2025 global sales. Meanwhile, against the backdrop of Tezspire’s first-in-class wins, drugmakers are developing more anti-TSLP agents. GSK recently launched phase 3 tests of its twice-yearly candidate felcorekibart (GSK5784283) for COPD and asthma after buying the long-acting drug in 2024. Last year, Roche licensed a TSLPxIL-33 bispecific antibody from China’s Qyuns Therapeutics in a deal potentially worth more than $1 billion. Qyuns also out-licensed a TSLPxIL-13 bispecific candidate to Windward Bio, which secured $165 million in crossover financing in May to help advance a twice-yearly anti-TSLP candidate into phase 3. Sanofi is also developing a TSLPxIL-13 bispecific nanobody called lunsekimig, which recently hit goals in a pair of midstage studies for asthma and CRSwNP.