In about 18 months' time Novartis will find out whether it made a mistake to give up on the blood-thinning project abelacimab. The MAb, spun out into the Blackstone-backed Anthos Therapeutics in 2019, yesterday became the first factor XI inhibitor to begin phase 3 patient enrolment. Two pivotal studies, Aster and Magnolia, are now under way, both with primary completion dates of September 2023. The mechanism (abelacimab also hits factor XIa) is an unusual area of research, featuring a small handful of big players, with Bayer and Bristol Myers Squibb working on several distinct assets. Both have franchises to defend: the former’s Xarelto loses US patent protection in 2024, while the latter’s Eliquis will likely go two years later. Unusually, Bristol’s Eliquis partner Pfizer is not active in factor XI, and was asked about this on its first-quarter call. It said: "We really want to see a similar step-up in breakthrough potential as we saw with Eliquis. And we haven't yet been convinced about that step-up, but we are carefully monitoring." The Aster study compares abelacimab head to head against Eliquis, so the answer – for Novartis and Pfizer alike – will come soon enough.
| Selected inhibitors of factor XI or XIa | |||
|---|---|---|---|
| Project | Company | Mechanism | Study design/status |
| Phase 3 | |||
| Abelacimab (MAA868) | Anthos (ex Novartis) | Anti-factor XI & XIa MAb | Aster vs Eliquis Magnolia vs LMW heparin |
| Phase 2 | |||
| Osocimab (BAY1831865) | Bayer | Anti-factor XIa MAb | Convert, in dialysis, ended Dec 2021 |
| Fesomersen (IONIS-FXI-LRx/ ISIS 416858/ BAY2306001) | Bayer/ Ionis | Factor XI ligand conjugated antisense | Emerald, in dialysis, ended Dec 2019 |
| Asundexian (BAY 2433334) | Bayer | Oral factor XIa inhibitor | Pacific-AMI ended Feb 2022 Pacific-Stroke ended Feb 2022 |
| Milvexian (JNJ-70033093/ BMS-986177) | Bristol Myers Squibb/J&J | Oral factor XIa inhibitor | Axiomatic-SSP ended Apr 2022 |
| AB023 | Aronora | Anti-factor XI MAb | NCT03612856, in dialysis, ended 2019 |
| Phase 1 | |||
| ONO-7684 | Ono Pharmaceutical | Oral factor XIa inhibitor | NCT03919890 ended 2019 |
| BMS-986209 | Bristol Myers Squibb | Oral factor XIa inhibitor | NCT04154800 ended Aug 2021 |
| BMS-262084 Oral | Bristol Myers Squibb | Non-peptide factor XIa inhibitor | Unclear |
| Source: Evaluate Pharma & clinicaltrials.gov. https://www.evaluate.com/vantage/articles/news/snippets/anthos-goes-pivotal-novartis-and-pfizer-look | |||
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