Lilly shares MASH data on tirzepatide; Cytokinetics on past sale discussions

Eli Lilly's drug tirzepatide, marketed as Zepbound for obesity, has shown promising results in treating liver disease MASH (Metabolic Associated Steatohepatitis). Recent clinical trial data, disclosed ahead of a European medical conference, indicates that after one year, tirzepatide improved liver fibrosis in over half of the participants without worsening MASH. This is compared to 30% improvement in the placebo group. Although Lilly had hinted at these results earlier in the year, the full dataset will offer a more comprehensive view of tirzepatide’s effectiveness. This abstract was released shortly after Viking Therapeutics announced trial data for its MASH treatment pill VK2809 and nearly two months following Madrigal Pharmaceuticals’ U.S. approval for the first MASH drug. As a result, Madrigal’s shares, along with those of other MASH drug developers, experienced a decline.

Cytokinetics' CEO, Robert Blum, confirmed that the biotechnology company engaged in acquisition talks late last year. This was initially reported by The Wall Street Journal and Reuters. Speaking at a conference hosted by investment bank Jefferies, Blum disclosed that Cytokinetics had entered into good-faith negotiations with an unnamed third party. Despite the board’s support for the terms, the other company ultimately decided not to proceed with the acquisition.

Gilead Sciences has agreed to settle federal lawsuits alleging that the company delayed the introduction of an antiviral treatment to extend patent protection for its HIV drug portfolio. Without admitting liability or wrongdoing, Gilead will pay up to $40 million to around 2,625 plaintiffs, provided that 98% of the claimants agree to the settlement terms. However, litigation in California regarding this issue, which involves two forms of the HIV drug tenofovir, is still pending before the state’s supreme court.

AbbVie announced that it has enrolled the first patient in a Phase 3 clinical trial for its dual-acting antibody, ABBV-383, aimed at treating multiple myeloma. ABBV-383 targets BCMA proteins on diseased cells and CD3 proteins on T cells to initiate an immune response against this blood cancer. This mechanism resembles that of approved drugs from Johnson & Johnson and Pfizer. AbbVie's trial will include 380 participants whose disease has progressed after at least two lines of therapy. Patients will be administered either ABBV-383 or another combination therapy, with researchers tracking treatment responses and evaluating if ABBV-383 can better prevent cancer progression compared to alternative treatments.

Two new clinical trials will investigate Gilead Sciences' long-acting HIV drug, lencapavir, for its efficacy as preventive therapy in cisgender women and people who inject drugs. Funded by Gilead and conducted through the HIV Prevention Trials Network, these studies aim to determine whether biannual injections of lencapavir are more effective as pre-exposure prophylaxis compared to current regimens. The National Institutes of Health, which supports the trials network, noted that cisgender women and injectable drug users have been underrepresented in HIV treatment studies.

In summary, significant developments have occurred this week in the biopharmaceutical industry, including promising clinical data, settlement agreements, the initiation of new trials, and acquisition talks. These updates reflect ongoing efforts to advance treatments for conditions such as MASH, multiple myeloma, and HIV, showcasing the dynamic nature of medical research and pharmaceutical innovation.