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Lilly drops Hanmi-partnered arthritis drug

Concludes that its BTK inhibitor is likely to be clinically ineffective

Eli Lilly

Eli Lilly has decided to abandon trials of its BTK inhibitor HM71224 in rheumatoid arthritis after an interim look at its prospects.

Lilly licensed HM71224 (LY3337641) from South Korean biotech Hanmi Pharmaceutical in 2015 for $50m upfront and milestones of $640m, but after two years of phase II testing has concluded that there is little chance of showing efficacy.  No decision has yet been taken on other autoimmune disease indications for the drug, such as lupus, lupus nephritis, and Sjögren’s syndrome, according to analyst Hur Hye-min of Hi Investment & Securities.

Lilly’s willingness to take a risk on continuing development of the drug in other indications may be cut now that it has won approval for JAK inhibitor Olumiant (baricitinib) for rheumatoid arthritis in Europe and after a delay has refiled the drug in the US, he said.

Hanmi reported the decision to the Korean financial authorities last week, and saw its shares slide on the announcement. The Korean firm has negotiated a series of alliances in the last three years with pharma multinationals - including Sanofi, Johnson & Johnson and Boehringer Ingelheim - although the latter ended in disappointment in 2016. Boehringer handed back rights to EGFR inhibitor olmutinib (HM61713) after serious side effects were seen in phase III trials.

The first BTK inhibitor to reach the market was Johnson & Johnson (J&J) and Pharmacyclics' Imbruvica (ibrutinib), but this has been introduced initially for blood cancers including chronic lymphocytic leukaemia (CLL) and is not in trials for autoimmune diseases.

Merck KGaA is among the front-runners among companies developing BTK inhibitors for inflammatory diseases, with its evobrutinib progressing to phase IIb testing in rheumatoid arthritis last September, while Bristol-Myers Squibb has its candidate BMS-986142 in mid-stage testing, as does Principia Biopharma with PRN1008.

Meanwhile, Pharmacyclics (now part of AbbVie) has a BTK inhibitor called ABBV-105 in early-stage clinical testing for arthritis, including a combination with JAK inhibitor candidate ABT-494.

Celgene was developing a BTK inhibitor for autoimmune diseases called spebrutinib (CC-292) - acquired along with Avila Therapeutics a few years back - but it no longer appears in the company’s pipeline.

Article by
Phil Taylor

20th February 2018

From: Research

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