Kyowa Kirin, Amgen’s Atopic Dermatitis Drug Delivers Strong Results in Phase 2 Trial

Only a few months into their collaboration, Amgen and Japanese biotech Kyowa Kirin has delivered positive Phase 2 trial results of Kyowa Kirin’s atopic dermatitis drug at the European Academy of Dermatology and Venereology 30th Virtual Congress.

A Potential First-in-Class anti OX40 Antibody

The autoimmune disease drug is called KHK4083 (AMG 451). It is a potential first-in-class anti-OX40 monoclonal antibody designed to treat patients with moderate-to-severe atopic dermatitis, also called eczema. Kyowa Kirin and Amgen’s collaboration on the development and commercialization of the drug began in June 2021.

The Phase 2 Trial

In the Phase 2 trial, the safety and efficacy data of KHK4083 was examined in 274 patients with moderate-to-severe atopic dermatitis that could not be adequately controlled with topical agents. The patients were divided into 5 groups where they were randomly assigned to receive 600 mg KHK4083 every 2 weeks, 600 mg every 4 weeks, 300 mg every 2 weeks, 150 mg every 4 weeks, or a placebo.

Amgen and Kyowa Kirin then looked at the improvement of the Eczema Area and Severity Index (EASI) score in week 16 from baseline.

A Near 60% Drop in EASI Score in Week 16

The results came back positive. Four KHK4083 groups demonstrated statistically significant improvement in week 16. Among them, 2 groups stood out. The EASI score went down by 57.4% in patients who took 600 mg KHK4083 every 2 weeks, and the group that received 300 mg every 2 weeks had a 61.1% drop in the score, whereas the score of the placebo group was only reduced by 15%.

Additionally, KHK4083’s most common side effects were nasopharyngitis, worsening of atopic dermatitis, chills, and mild to moderate pyrexia (fever). No patients discontinued the trial due to side effects, and patients were followed up to week 56.

With positive results from the Phase 2 trial in hand, the pair plans to advance KHK4043 to Phase 3 in the first half of 2022.

Author

Tyler Chen

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