Dive Brief:
- Eli Lilly & Co. has shut down Phase 2 rheumatoid arthritis trials for a BTK inhibitor licensed from Hanmi Pharmaceutical following poor interim results.
- Lilly licensed the oral Bruton's tyrosine kinase (BTK) inhibitor, in an exclusive $690 million deal for autoimmune disease in 2015.
- The agreement between the two companies covered a handful of indications, and the future of the drug is still in discussion, according to both companies.
Dive Insight:
The Phase 2 trial of LY3337641/HM71224 – known as the RAjuvenate study – began in August 2016, and was expected to be completed in May 2019, but it now seems it's not going to get that far. While the interim results haven't been published yet, both companies agree that they weren't what was hoped for.
"After a scheduled review of the data, it was determined that the difference between the placebo and active treatment arms of the study was not sufficient enough to support the continuation of the trial. Lilly and Hanmi are in discussions about the next steps for the molecule," wrote a Lilly Research Laboratories Communications adviser in an email to BioPharma Dive.
Hanmi Pharmaceutical Co. Ltd told the Korea Biomedical Review: "Our partner firm Lilly has decided to discontinue the phase-2 trials of selective BTK (Bruton's tyrosine kinase) inhibitor (LY3337641/HM71224) in patients with rheumatoid arthritis because interim results showed that the study could fail to demonstrate its target effectiveness."
The original deal was struck in 2015, as the treatment was poised to enter Phase 2 trials. Lilly gained exclusive worldwide rights outside China, Hong Kong, Taiwan, and Korea, in return for an initial payment of $50 million, and up to $640 million in milestone payments, as well as tiered double digit royalties. The plan was to investigate the small molecule in autoimmune disease including rheumatoid arthritis, lupus, Sjögren's syndrome, and other related conditions. While the drug was Phase 2 ready at the time of the agreement, the rheumatoid arthritis study was the only efficacy study ever started.
There is interest out there in BTK inhibitors for a variety of indications, so Hanmi may be able to find another buyer if Lilly pulls out, though no decisions appear to have been made yet.
AstraZeneca plc's Calquence (acalabrutinib) was approved last November for mantle cell lymphoma, and the company believes that it will be a "cornerstone" of its hematology business. AbbVie's Imbruvica (ibrutinib) is approved for leukemias and lymphomas, and most recently chronic graft-versus-host disease. Sanofi SA acquired Principia Biopharma Inc.'s PRN2246 for multiple sclerosis. And Loxo Oncology picked up Redx Pharma's BTK inhibitor program for $40 million.