American pharmaceutical giant Pfizer is planning to take its trispecific antibody, tilrekimig, to Phase III in atopic dermatitis (AD) as the company looks to grab a slice of this fast-growing market.
The company will progress tilrekimig following the positive outcome of a Phase II study (NCT02780167), in which 269 patients with moderate-to-severe AD were given either a low, medium or high once-monthly dose of tilrekimig or placebo over the course of 16 weeks.
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Within the treatment period in the second stage of this study, tilrekimig triggered a significant increase in the percentage of patients achieving an eczema area and severity index (EASI)-75 score compared with placebo. Across the low, medium and high-dose cohorts, 38.7%, 51.9% and 49.4% of patients met this clinical milestone compared to placebo – meeting the trial’s primary endpoint. Pfizer is yet to disclose the percentage of patients that achieved EASI-75 in the placebo group.
Rates of treatment-emergent adverse events (TEAEs) across the tilrekimig cohorts were also comparable to placebo, with patients given the drug most commonly experiencing infections, skin disorders and injection site reactions. While three serious events were recorded in this study, all were considered unrelated to treatment.
Pfizer will present more detailed results from the Phase II study at a future medical meeting. Based on the Phase II data, a pivotal, Phase III trial of the drug is due to start in 2026.
Pfizer eyes larger slice of AD market
According to Pfizer’s chief inflammation and immunology officer, Mike Vincent, these Phase II results demonstrate tilrekimig’s potential to “deliver improved efficacy over standard of care for AD”, which includes blockbuster sellers like Sanofi’s Dupixent (dupilumab) and AbbVie’s oral Janus Kinase (JAK) inhibitor, Rinvoq (upadacitinib).
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By GlobalDataLike Dupixent, tilrekimig acts by blocking interleukins 4 and 13 (IL-4; IL-13), though the drug differs from its market competitor by simultaneously blocking thymic stromal lymphopoietin (TSLP) – an epithelial cytokine associated with increased skin inflammation in patients with AD.
The drug has also shown promise at a once-monthly dosing schedule, meaning it could offer an advantage in terms of dosing frequency over Dupixent, which requires biweekly administration. However, Nektar’s T-regulatory (Treg) cell therapy, rezpeg, demonstrated strong efficacy at a once-quarterly dosing schedule in a Phase II AD trial.
If tilrekimig were to make it to market, it would enter a highly competitive AD landscape, which has been revolutionised by biologics like Dupixent in the moderate-to-severe settings, as per a report from GlobalData, parent company of Clinical Trials Arena.
According to Tanuj Sircar, associate director of Competitive Intelligence at GlobalData, prescribers are likely to favour established, marketed biologics over tilrekimig if the drug were to gain approval. However, he notes that Pfizer “may seek to highlight its broader-acting mechanism as a means to address the heterogenetiy of AD, while preserving high selectivity with minimal off-target effects – potentially conferring a favourable safety profile versus systemic JAK-1 inhibitors”.
This could be backed by the lower observed rate of conjunctivitis, a common side effect associated with anti-IL-4/IL-13 biologics, seen in the Phase II study on Pfizer’s AD drug.
“Tilreikimg may be able to capture response in patients who have inadequately responded to prior biologics and may be hesitant to switch to JAK inhibitors given the safety risks associated with the class,” Sircar added. “Depending on its life-cycle management and further indications that it can gain approval in, Pfizer may also aim to capture patients with atopic comorbidities such as asthma or COPD, as this benefit is currently leveraged by Dupixent only”.
GlobalData forecasts that the AD market will be worth $22.4bn in 2033 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan). This includes Pfizer’s Janus Kinase 1 (JAK1) inhibitor, Cibinqo (abrocitinib) and topical therapy, Eucrisa (crisaborole). GlobalData forecasts these drugs will pull in sales of $512m and $158m in 2031, respectively.
Pfizer has three other drugs in development for AD, including trispecific IL-4, 13 and 33 blocker, ompekimig, and two Phase I candidates.
