2021-10-05| Trials & Approvals

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

by Tyler Chen
Share To

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.

© All rights reserved. Collaborate with us:
Related Post
Recounting 25 Years of Genetic and Human Diversity Discovery With deCODE Founder Kari Stefansson
Asahi Kasei Medical Ups CDMO Business in the US with Bionova Buy
Moderna Shares Promising Preliminary Bivalent COVID-19 Booster Results
Flagship-Backed ProFound Launches With $75 Million to Discover Human Proteins
Janssen’s First Cell Therapy Gets Europe’s Approval for Multiple Myeloma
Cell and Gene Therapy Landscape in Japan is Moving Beyond Oncology
New Study Reveals Hope for Recovery of Patients with Spinal Cord Injury
Laekna Therapeutics Announces Dosing of First Patients in the U.S. and China in Phase Ib/III Study of Afuresertib in Combination with Fulvestrant in HR+/HER2- Breast Cancer
Stanford Touts Remote-Controllable CAR-T Cell Therapy
Phenomix Launches The First Obesity Biobank Registry To Study Underling Phenotypes
ASCO Annual Meeting
Online and on-side
Digital RESI June
BIO International Convention
San Diego, CA
Hong Kong, China
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!