AbbVie Ditch Phase II Autoimmune Drug
During their Q3 earnings call on Friday, AbbVie announced that they are ceasing the development of ROR? inverse agonist cedirogant. The decision was made following analysis of a toxicology report from its Phase IIb trial. The news marks the end of their ten-year partnership with Inventiva and cuts off a significant source of cash for the French biotech.
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ROR? is a protein mainly expressed in immune cells and targeting the protein has been recognised as a promising mechanism for treating autoimmune diseases. AbbVie and Inventiva's multi-year drug discovery collaboration was established in 2012 to identify potent ROR? agonists capable of suppressing a broader set of inflammatory cytokines than currently available biologics.
Cedirogant (or ABBV-157) was the resultant molecule designed to treat psoriasis. AbbVie began the Phase II drug trial earlier this year, and the trial was due to finish in March 2023. When announcing that development was ceasing, Tom Hudson, AbbVie’s senior vice president of R&D and CSO, did not disclose the precise reason, simply stating that it was “due to new findings observed in our preclinical toxicology study”.
This is not the first time that targeting ROR? has proven challenging in practice. SVB securities analysts noted that AbbVie’s decision marked “another failure in the development of oral ROR? treatment therapies.” They cited safety concerns as the primary reason behind several ROR? program suspensions, including programs at GSK, Boehringer, and Takeda.
SVB securities analysts noted that AbbVie’s decision marked “another failure in the development of oral ROR? treatment therapies.”
The end of cedirogant development marks a significant loss of future funding for Inventiva; under the partnership with Abbvie, the French firm had received at least €30 million in research funding and milestone payments. This January alone they had an injection of €4 million at the start of the Phase II trial.
AbbVie’s announcement led to a 21% fall in Inventiva’s share price in premarket trading on Monday. However, the firm does not appear too worried by the loss. In their official announcement, Inventiva expressed disappointment at the end of the ten-year partnership, before going on to signal that they are now “fully focused on the development of [their] lead asset lanifibranor, a promising treatment [for] NASH," with mid-phase studies into the molecule scheduled to report results next year.
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