Weeks after starting, Amgen flashes yellow light on PhIII of $400M eczema bet
Amgen is taking its foot off the pedal just a few weeks after beginning a late-stage trial of a Kyowa Kirin drug for which it dished out $400 million last year in exchange for ex-Japan rights.
The California pharma has paused the Phase III ROCKET-IGNITE study, according to its Japanese partner’s latest earnings report Thursday. The 52-week, 570-patient trial began in June and is expected to collect final primary outcome data in March 2024, according to a federal trials database, which cites the study as active, but not recruiting.
The news comes the same morning as Amgen said it would pay about $4 billion to buy ChemoCentryx, giving the company access to the autoimmune disease drug Tavneos. Amgen will disclose quarterly earnings after the markets close Thursday.
No safety or efficacy issues were seen, but Kyowa reported that after “additional discussions with regulators and our partner, we are amending the studies to improve patient convenience and investigate a range of doses.”
An Amgen spokesperson emailed a similarly worded statement to Endpoints News, adding, “We continue to remain excited about the broad potential of this program in atopic dermatitis.”
The randomized study is looking at evaluating AMG 451, also known as KHK4083 and rocatinlimab, in adults with moderate-to-severe atopic dermatitis. The pact with Kyowa, which includes potential for $850 million in biobucks, is Amgen’s foray into a field dominated by Regeneron and Sanofi’s Dupixent.
Amgen and Kyowa’s drug is an anti-OX40 antibody. Kyowa Kirin chief research officer Andrew McKnight previously told Endpoints that “OX40 delivers a survival signal to T cells; it upregulates anti-apoptotic gene transcription. So you’ve got the survival of the T cells and their differentiation into memory cells. So that’s blocked. And while that’s been blocked we’re also depleting the OX40 positive cells in the lesions of atopic dermatitis patients.”
Sanofi is targeting OX40L with amlitelimab, which it picked up through the Big Pharma’s $1.45 billion buyout of Kymab in January 2021. The monoclonal antibody, also known as SAR445229 and previously KY1005, is being studied in Phase II clinical trials in patients with atopic dermatitis and adults with moderate-to-severe asthma.
The Phase IIb STREAM-AD study out of Sanofi is slated to collect final primary outcome data in June 2023 after kicking off in March of this year.
Editors’ note: This article was updated to clarify Amgen and Kyowa’s drug targets OX40, not OX40L.