Eli Lilly has given up on its autoimmune disease therapy tabalumab after it failed to show sufficient clinical benefit in two phase III lupus trials.
The latest setback came after tabalumab had already failed a late-stage study in rheumatoid arthritis last year, despite some signs of efficacy for a higher dose of the drug in the lupus study. The company said it would take a $75m charge in the fourth quarter as a result of the decision, adding to a $50m charge booked last year on the arthritis failure.
In the first of the two lupus studies – ILLUMINATE 1 – the BLyS/BAFF-targeting antibody failed to meet its primary efficacy objective of a significant improvement on the SRI-5 lupus disease activity scale compared to standard therapy.
The higher dose did achieve this in the second ILLUMINATE 2 trial but – on balance – Lilly has concluded that the drug’s clinical profile does not warrant further development “in the context of existing treatments.”
Tabalumab had already been relegated by most analysts to secondary status in Lilly’s pipeline after the arthritis study, with a number expecting peak sales in the region of $250m or so a year from lupus and possibly multiple myeloma, for which it was in mid-stage testing.
The latest setback marks a barren spell for Lilly in bringing new products to market in the last few years, with a number of late-stage failure including edivoxetine for depression, schizophrenia candidate pomaglumetad methionil and Alzheimer’s candidate solanezumab, although the latter remains in clinical testing as an early-stage therapy.
On the plus side, it has secured approval for diabetes drugs Trulicity (dulaglutide) and Jardiance (empagliflozin), as well as stomach cancer drug Cyramza (ramucirumab), although the sales potential of the latter drug has been dented by failures in liver and breast cancer.
Meanwhile, it does have a good crop of drugs in its late-stage pipeline including lung cancer therapy necitumumab, abemaciclib for lung and breast cancer, baricitinib for arthritis, evacetrapib for cholesterol-lowering, diabetes candidate insulin peglispro and ixekizumab for psoriasis.
Lilly’s share price was largely unaffected by the tabalumab announcement, although the news did weight a little on shares of Anthera Pharmaceuticals, another company developing a BLyS/BAFF inhibitor for lupus.
Anthera said this week it was in partnership negotiations for the drug – called blisibimod – in territories outside the US.