Lilly details MASH data for tirzepatide; Cytokinetics comments on past sale talks

Today, a brief rundown of news from Eli Lilly, Cytokinetics and AbbVie, as well as updates from Gilead and the National Institutes of Health that you may have missed from earlier this week.

Eli Lilly’s drug tirzepatide — sold as Zepbound for obesity — continues to show promise in the liver disease MASH. Clinical trial data disclosed in an abstract ahead of a European medical conference indicates that, after one year, the shot helped improve liver fibrosis without worsening MASH in just over half of treated participants, compared with 30% of those given placebo. Lilly had hinted at the study’s success earlier this year, but the full data will provide a more complete view of tirzepatide’s potential. The abstract’s release comes one day after Viking Therapeutics released trial data for its MASH pill VK2809 and less than two months after Madrigal Pharmaceuticals won U.S. approval of the first MASH drug. Madrigal shares fell Wednesday morning, as did those of several other MASH drug developers. — Jonathan Gardner

Cytokinetics CEO Robert Blum confirmed the biotechnology company held sale talks late last year, as was reported around then by The Wall Street Journal and Reuters. In comments at a conference hosted by the investment bank Jefferies Wednesday, he said Cytokinetics engaged in “good faith negotiations” with an unnamed third party regarding an acquisition. While Cytokinetics’ board was supportive of proceeding with discussions on “substantially the terms the counterparty communicated,” that company ultimately did not move forward with an acquisition. — Ned Pagliarulo

Gilead Sciences has reached an agreement to settle federal lawsuits alleging the company delayed introducing an antiviral treatment so that it could extend patent protection for its HIV drug business. The company, which has not admitted liability or wrongdoing, will pay up to $40 million to a group of approximately 2,625 plaintiffs, provided 98% agree to the settlement. Litigation in California on this same issue, which involves two forms of the HIV drug tenofovir, remains pending at the state’s supreme court. — Ned Pagliarulo

AbbVie said Wednesday it has enrolled the first patient in a Phase 3 trial of its dual-acting antibody ABBV-383 for multiple myeloma. ABBV-383 binds to a protein flag called BCMA on diseased cells and another called CD3 on T cells to spur an immune attack on the blood cancer. The mechanism is similar to that of the approved drugs from Johnson & Johnson and Pfizer. AbbVie’s trial will enroll 380 people whose disease has progressed after at least two lines of therapy. Patients will receive either ABBV-383 or another combination therapy. Researchers will follow patients to assess treatment responses and whether AbbVie’s drug helps stave off cancer progression better than the comparator treatments. — Jonathan Gardner

Two clinical trials will test Gilead Sciences’ long-acting HIV drug lencapavir as preventive therapy in cisgender women and in people who inject drugs. The studies, which are funded by Gilead and run through the HIV Prevention Trials Network, will test whether twice-yearly injections of lencapavir works better as pre-exposure prophylaxis than an existing regimen. Cisgender women and injectable drug users have been underrepresented in studies of HIV treatment, according to a statement from the National Institutes of Health, which provides grants to the trials network. — Ned Pagliarulo

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