Eli Lilly has halted a phase 2 rheumatoid arthritis trial after getting a mid-study glimpse at the data. The setback leaves Lilly and partner Hanmi Pharmaceutical to weigh whether it is worth moving the Bruton's TKI forward in other indications.
Hanmi disclosed the suspension of the trial in a statement to investors in Korea. The statement said Lilly stopped the study after an interim review revealed the trial was unlikely to hit its efficacy goal. Lilly designed the 276-patient, placebo-controlled trial to show the drug, LY3337641, could drive a 20% or greater improvement on a rheumatoid arthritis symptom scale.
Lilly is yet to comment on the study. Hanmi thinks the drug may still have a future in other indications and is talking to Lilly about the next steps for the asset. Lilly highlighted the potential of LY3337641 in lupus, Sjögren's syndrome and other conditions when it landed rights to the TKI. But the clinical trial program has so far only tested it in healthy volunteers and rheumatoid arthritis patients.
Investors gave short shrift to Hanmi's attempts to downplay the significance of the trial cancellation, driving its stock down 10%. That slide led to reports in local publications including Korea Biomedical Review.
Both companies have other drugs to fall back on if LY3337641—also known as HM71224—ends up on the scrapheap. Hanmi has seven other assets in phase 2 and beyond, including a once-weekly GLP-1 receptor antagonist that has advanced into a phase 3 diabetes trial in partnership with Sanofi.
For Lilly, LY3337641 was a relatively small bet. Lilly picked up the rights to LY3337641 outside of China and Korea for $50 million upfront in 2015. The deal also included $640 million in milestones. The company has multiple other immunology assets in its mid to late-phase pipeline, including JAK1/2 inhibitor baricitinib.