Eli Lilly and Hanmi Shutter a Failed Phase II RA Trial
Eli Lilly and Company and its Korean collaborative partner Hanmi Pharmaceutical, Co., Ltd stopped a Phase II trial on an experimental rheumatoid arthritis treatment after less-than-stellar interim results were examined.
Although Lilly has remained mum on the trial’s halting, Hanmi broke the news in a regulatory filing, according to Korea Biomedical Review. In a regulatory filing, Hanmi said Lilly opted to discontinue the trial after interim results showed a lack of efficacy. Lilly and Hanmi were studying the effects of a Bruton's tyrosine kinase (BTK) inhibitor (LY3337641/HM71224) in patients with rheumatoid arthritis.
Lilly and Hanmi forged a collaborative agreement for HM71224 in 2015. When the two companies struck the deal worth up to $690 million, they said that in addition to RA the drug would also be explored as a potential treatment for lupus, lupus nephritis, Sjögren's syndrome, and other related conditions. In its filing Hanmi said the two companies are still looking to develop the drug for those other conditions, Korea BioMedical Review noted in its report today.
At the time the two companies struck the deal they expressed hope for HM71224 to have an effect on prevalent autoimmune diseases.
“We're highly encouraged by the potential of HM71224 to deliver an innovative, first-in-class treatment option,” Eli Lilly said at the time the 2015 deal was struck.
Shares of Hanmi Pharmaceuticals, which trades on the Korean Stock Exchange, fell about 9 percent on the news of the failure.
Hanmi has several developmental partnerships in addition to the collaboration with Eli Lilly. While Hanmi said it will continue to work with Eli Lilly, if the Indianapolis-based company opts to walk away completely it won’t be the first time that’s happened to Hanmi. In October 2016 Boehringer Ingelheim walked away from its $730 million partnership with Hanmi over safety concerns of the cancer drug olmutinib.
Rheumatoid arthritis affects an estimated 23.7 million people worldwide. The condition is a chronic inflammatory condition characterized by pain, swelling of the joints, stiffness and disability. There are approximately 1.5 million people in the United States who have been diagnosed with RA. Because of the wide patient population, it’s a popular target for drugmakers.
Although Lilly halted the BTK inhibitor trial, the company is still focused on a hoped-for approval of baricitinib. Last year the U.S. Food and Drug Administration rejected the drug over blood clot worries. But then the regulatory agency reversed course and invited the company to resubmit the drug for approval, which it did.