Despite prior setbacks, Lilly executives said they’re pressing ahead with new research in lupus at a time when other companies are taking to cell therapy to crack the hard-to-treat disease.
Paul Klekotka, VP of medical immunology at Lilly, said in an interview at the company’s biotechnology hub in San Diego that Lilly was “not totally scared of lupus anymore” after getting a better sense of the high placebo response rates that occurred in past trials.
Paul Klekotka“Lupus is in scope for us,” he confirmed via email.
There are no assets indicated for the disease in Lilly’s publicly available pipeline, though the company has completed a Phase 2 study testing a BTLA agonist in patients with systemic lupus erythematosus, according to the federal clinical trials database. It has not yet disclosed the data from that trial.
“As long as the molecule we design works, I’m not scared at all,” said Jirong Lu, Lilly’s SVP of biotechnology research and head of the Lilly Biotechnology Center.
Lilly has faced similar challenges developing treatments for lupus as other companies.
Almost 10 years ago, Lilly discontinued development of tabalumab after “insufficient efficacy” in two Phase 3 trials. Then, in January 2022, the company reported a late-stage failure for Olumiant, the JAK inhibitor it was developing with Incyte, prompting a winding down of the long-term extension trial. And last year, it opted out of a collaboration with Nektar Therapeutics following a mid-stage miss in lupus for their partnered drug, rezpegaldesleukin.
“We’ve had a couple of molecules go through there and obviously not be successful,” Klekotka said.
He attributed past failures in part to high placebo rates, citing the challenges of recruiting patients who either don’t have confirmed disease or have undergone treatment with steroids.
He also noted that researchers are turning their attention back to addressing dysfunctional B cells, which is emblematic of the growing interest in testing cell therapies in lupus patients.
Kyverna Therapeutics raised $319 million in an IPO in February. Its lead asset is aimed at autoimmune conditions, including lupus. Nkarta Therapeutics recently reprioritized its NK cell pipeline to elevate a lead lupus program, with the first patient slated to be dosed in the first half of the year.
Jirong LuA year ago, Lilly acquired encapsulated cell therapy biotech Sigilon Therapeutics for $309.6 million, though the focus was on a type 1 diabetes treatment. Lu said there isn’t a huge focus on cell therapy internally at this time, but that could change based on new data.
“Certainly, if there’s promise in cell therapy … we will definitely keep our eye on that,” she said.