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Lilly says lupus drug dropped from pipeline failed to show efficacy

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An experimental BTLA agonist that Eli Lilly cut from its pipeline for lupus late last year failed to show strong enough efficacy in a mid-stage trial, the company confirmed to Endpoints News.

The program’s clinical trial record was updated Friday to reflect the termination of the drug, LY3361237, which was being tested in patients with at least moderately active systemic lupus erythematosus. Lilly plans to report complete data at an “appropriate scientific forum,” a company spokesperson said.

Targeting BTLA, an inhibitory immune checkpoint that can restrict B and T cell responses, has been a hot target for both autoimmune conditions and for cancer by turning the immune system down or up, to either stop unwanted attacks against the body, or to help it target malignant cells.

Lilly had already removed LY3361237 from its pipeline as of October 2023, according to an earnings presentation last year, but the trial remained active. The 85-person study completed in February 2024, according to an earlier update, but nothing about the drug’s safety or effectiveness had been publicly reported.

Lilly has said it remains invested in treating lupus, and Paul Klekotka, Lilly’s VP of medical immunology, told Endpoints in June that the disease remained “in scope” despite previous trial failures.

“As long as the molecule we design works, I’m not scared at all,” said Jirong Lu, SVP of biotechnology research and head of the Lilly Biotechnology Center, in the same June interview.

Like other biopharmas, Lilly has taken its licks in previous attempts to crack lupus. Before the latest cull, the company had backed out of a deal with Nektar Therapeutics after the two’s partnered candidate, rezpegaldesleukin, missed in a mid-stage trial.


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