▎WuXiEdited by Kant Content Team

Recently, Amgen announced the positive topline results of rocatinlimab, an investigational OX40-targeting monoclonal antibody jointly developed with Kyowa Kirin, in the HORIZON Phase 3 clinical trial. The analysis showed,The therapy met the co-primary endpoints and all key secondary endpoints, with rocatinlimab significantly improving the clinical symptoms of patients with atopic dermatitis (AD).The two companies will announce the detailed results of the trial at a future medical conference. Amgen also announced its drug.Uplizna (inebilizumab) met the primary endpoint in a Phase 3 trial for the treatment of patients with generalized myasthenia gravis (gMG), and the company has initiated preparations for the relevant regulatory submissions.

Atopic dermatitis is the most common type of eczema, a chronic inflammatory disease that causes excessively dry, itchy, and painful skin.Patients with moderate to severe atopic dermatitis experience chronic symptoms, unpredictable flare-ups that exacerbate the condition, potentially causing pain and disrupting daily life.Nearly half of these patients reported experiencing severe itching, leading to repeated scratching, which can cause skin thickening and increase the risk of infection.Atopic dermatitis affects 15-20% of children and up to 10% of adults. T-cell imbalance is the root cause of atopic dermatitis, leading to clinical manifestations including recurrent episodes and unpredictable symptoms.

HORIZON is a 24-week randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and tolerability of rocatinlimab monotherapy in adult patients with moderate to severe atopic dermatitis. HORIZON is one of eight studies in the global ROCKET Phase 3 clinical trial program.

▲HORIZON Trial Design (Source: Reference [1])

Analysis shows that HORIZON has achieved both primary endpoints.That is, at Week 24, compared with patients in the placebo group,A significantly higher proportion of patients in the rocatinlimab group achieved a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear skin) or 1 (almost clear skin) with a reduction of ≥2 points from baseline compared to the control group (19.3% vs. 6.6%, difference of 12.8%, p<0.001).；A higher proportion of patients in the rocatinlimab group achieved a 75% reduction in the Eczema Area and Severity Index from baseline (EASI-75) compared to the control group (32.8% vs. 13.7%, difference 19.1%, p<0.001).The trial also met the revised Investigator's Global Assessment (rIGA 0/1) endpoint at week 24, a stricter efficacy measure than vIGA 0/1, based on a more rigorous definition of near-complete resolution of skin symptoms (16.4% vs. 4.9%, a difference of 11.5%, p<0.001).

The study also achieved statistically significant differences in all key secondary endpoints.These secondary endpoints include measurements of skin clearance (vIGA 0/1 and EASI-75 at Week 16, and EASI-90 at Week 24), the Numerical Rating Scale for pruritus, the Atopic Dermatitis Skin Pain Scale, the Dermatology Life Quality Index, and severity scores for hand and facial atopic dermatitis.

The overall safety results of the HORIZON trial were consistent with those from previous Phase 2b studies.

▲RocatinlimabDrug Mechanism(Image source: Reference [1])

Rocatinlimab is an OX40-targeted human monoclonal antibody currently under investigation for the treatment of moderate to severe atopic dermatitis.Rocatinlimab has the potential to become the first therapy to achieve T-cell rebalancing in the body by targeting OX40 to inhibit and reduce pathogenic T-cells.OX40 is a co-stimulatory receptor involved in driving systemic and local inflammatory responses in atopic dermatitis and other diseases. Previous studies have shown that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are crucial to the disease pathology. The therapy is also being evaluated for the treatment of moderate to severe uncontrolled asthma, prurigo nodularis, and other conditions where inflammation may result from T-cell imbalance. This therapy was initially discovered through a collaboration between Kyowa Kirin and the La Jolla Institute for Immunology.

At the same time, Amgen also announced its rare disease druginebilizumabMet the primary endpoint in the Phase 3 trial for the treatment of myasthenia gravis.Analysis shows that in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale,Receive two dosesinebilizumabPatients receiving the treatment showed a 4.2-point improvement in scores after 26 weeks, compared to a 1.9-point improvement in the placebo group (p<0.0001).In addition, four of the five secondary endpoints in this study showed statistically significant differences.

In June this year,AmgenPublishAnother clinical trial of inebilizumabTop-line results of the Phase 3 trial,inebilizumabReached the Primary Clinical Endpoint in the Treatment of IgG4-Related Disease (IgG4-RD)During the 52-week trial period containing a placebo control,The risk of IgG4-RD flare was significantly reduced by 87% compared to placebo (HR=0.13, p<0.0001).。Based on these positive data, Amgen plans to first submit a regulatory application to the U.S. FDA, followed by submissions in other countries and regions to expand.inebilizumabIndications.

▲InebilizumabDrug Mechanism(Image source: Reference [1])

InebilizumabIt is a humanized monoclonal antibody with high affinity for CD19.CD19 is expressed on various types of B cells, including antibody-secreting plasmablasts and plasma cells.By binding to the CD19 antigen,inebilizumabCapable of rapidly clearing these cells from the blood circulation, thereby reducing the production of autoantibodies and alleviating patient symptoms.It was initially developed by Viela Bio and received its first approval in 2020.FDA Approval, for the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD).

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References:

[1] Driving Long-Term Growth: Rocatinlimab and UPLIZNA® Update. Retrieved September 25, 2024 from https://investors.amgen.com/static-files/a7119a35-06de-497e-ba75-146404c54d95

[2] Kyowa Kirin Announces Top-line Data from Rocatinlimab Phase 3 ROCKET HORIZON Trial for Adults with Moderate to Severe Atopic Dermatitis. Retrieved September 25, 2024 from https://www.prnewswire.com/news-releases/kyowa-kirin-announces-top-line-data-from-rocatinlimab-phase-3-rocket-horizon-trial-for-adults-with-moderate-to-severe-atopic-dermatitis-302258420.html

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