AstraZeneca ($AZN) isn't the only pharma giant having problems with rheumatoid arthritis today. Eli Lilly ($LLY) threw in the towel on one of three Phase III studies of an experimental antibody for patients with RA after an interim analysis showed lack of efficacy.
A Lilly exec called the development "unexpected" because of midstage results, but Phase III flops from the Indianapolis-based giant have become too common.
Lilly seemed to leave the door open for the program, saying that the company is investigating the anti-BAFF antibody tabalumab (or LY2127399) in RA patients in two other Phase III studies. However, the company hit the brakes on enrollment in the program until further data from the studies are available in 2013. And late-stage studies of the experimental therapy are ongoing in patients with lupus.
The futility shown in the RA program doesn't bode well for the future of tabalumab in the massive and competitive market for drugs against the joint-attacking disease. It's also another in a string of setbacks for Lilly CEO John Lechleiter's strategy to avoid megadeals and rely heavily on the company's internal pipeline to provide new products to replace revenue from those such as the antidepressant Cymbalta that face generics competition.
Lilly has been dogged in keeping programs alive after mixed results in trials. Just yesterday the company revealed plans for another Phase III study of its Alzheimer's candidate solanezumab to look further into evidence of efficacy in patients with mild stages of the memory-robbing disease who took part in late-stage studies that ended in failure this year. Lilly isn't giving up on autoimmune diseases either.
"We remain committed to patients with rheumatoid arthritis and lupus and will move rapidly to evaluate the impact of these data on the overall tabalumab clinical development program," Dr. Eiry Roberts, Lilly's vice president of autoimmune product development, stated in a release. He noted that the poor showing in the discontinued study was "unexpected" because of data from midstage trials.
- here's the release
- and Reuters' update