March 3 (Reuters) – Kyowa Kirin on Tuesday said it is discontinuing all ongoing trials of its experimental drug to treat skin conditions after the company concluded that the potential risks may outweigh the benefits for patients.
The drug, called rocatinlimab, is a monoclonal antibody that was being tested to treat skin conditions such as moderate-to-severe atopic dermatitis, prurigo nodularis, which cause dry, itchy, and inflamed skin. It was also tested for moderate-to-severe asthma.
The decision was made after a recent planned safety update from the global rocatinlimab clinical program, Kyowa Kirin said.
The most recent safety review conducted over the last several weeks identified emerging concerns of malignant tumors with possible viral or immune-related links, the Japanese drugmaker said.
This included one new confirmed case and one suspected case of Kaposi’s sarcoma, a type of rare cancer that affects the skin, in addition to a previously confirmed case, suggesting a potential link to the way the drug is designed, the company said.
Rocatinlimab is an experimental drug that targets OX40, a protein which plays a role in inflammation and certain immune responses.
“This is deeply disappointing news, as we had hoped to bring a safe and effective treatment to patients,” said Abdul Mullick, chief operating officer of Kyowa Kirin.
Earlier this year, Kyowa Kirin announced the termination of its development and commercialization collaboration for rocatinlimab with Amgen.
Both companies are currently notifying clinical trial investigators and regulatory authorities and will provide further updates once data assessments are complete.
Kyowa Kirin said it will control the global rocatinlimab program, including regulatory filings and future commercialization.
(Reporting by Sneha S K in Bengaluru; Editing by Maju Samuel)
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