Lead Pharma Holding BV

When Abbott spun out its R&D group into AbbVie back in 2013, it also handed off a drug discovery deal that it had struck just months prior with another spinout — the French biotech Inventiva — around small molecule drugs that target RORγ, a protein often found on immune cells, to treat autoimmune diseases. Over the years, AbbVie took over the resulting drug, named it ABBV-157 (cedirogant), and moved it into Phase IIb. But the pharma giant is now winding down the whole program. Tom Hudson, AbbVie’s senior vice president of R&D and CSO, disclosed the news during AbbVie’s Q3 earnings call on Friday. (I)n the area of immunology, we recently made the decision to stop the clinical studies and discontinue development for ABBV-157, our RORyt inverse agonist. This decision was made due to new findings observed in our preclinical chronic toxicology study. Inventiva followed up Monday with its own update, expressing disappointment and thanking AbbVie for 10 years of collaboration. In its statement, it characterized the trigger as “analysis of a recently concluded nonclinical toxicology study.” Since AbbVie was fully in charge of cedirogant, the discontinuation doesn’t affect its cash runway or R&D plans — although it does seem to raise the stakes, even if slightly, on the lead program in NASH, lanifibranor. AbbVie was testing the compound in a Phase IIb trial for moderate-to-severe psoriasis, originally slated for completion in March 2023. Although AbbVie didn’t specify what it found in the toxicology study, SVB Securities analysts noted “the decision marks another failure in the development of oral RORγt therapies for PsO treatment” after Immunic recently reported disappointing Phase Ib results of its own RORγ inverse agonist in the same indication. Immunic blamed the flop on a surprisingly high placebo response. Inhibiting RORγ represents a promising mechanism for autoimmune diseases, but has proven challenging in practice, the analysts added. “Safety concerns have been the main reason behind multiple RORγt program suspensions. Specifically, programs from Vitae/Allergan (now ABBV), Sanofi/Lead Pharma, Boehringer, Japan Tobacco, GSK, Takeda, and AZN have all been discontinued,” they wrote. Under their partnership, Inventiva had received at least €33.4 million in research funding and milestone payments, including €4 million in January after AbbVie started the Phase IIb.