
Ionis gets a double whammy
On Friday Ionis touted positive mid-stage results with fesomersen, a member of a new class of anticoagulants. The data, in end-stage renal disease patients on dialysis, were clearly not enough to convince Bayer, however: Ionis’s erstwhile partner handed back rights, leaving the smaller group searching for a new collaborator. Bayer is more exposed than most to the factor XIs, a much-hyped class that threatens to disappoint after recent mid-stage failures for Bayer’s asundexian and Bristol Myers Squibb/Johnson & Johnson’s milvexian; the developers have pressed on into phase 3 regardless. Given the cost of these trials, it would not be surprising if Bayer opts to fully focus on asundexian – which could be bad news for another asset the two groups are partnered on, osocimab, due to yield data soon. Meanwhile, Ionis also expanded the phase 3 Cardio-TTRansform trial of eplontersen, its Astrazeneca-partnered amyloidosis project, in the cardiomyopathy disease subtype for a second time. Ionis pointed to earlier diagnosis, which could lead to lower numbers of cardiac events, but investors read the move as increasing the risk of a negative readout. The trial, which will now enroll 1,400 patients, is still set to report in the first half of 2025. Ionis’s stock closed down 7% on Friday.
Factor XI inhibitors in development | |||
---|---|---|---|
Project | Company | Description | Trial details |
Phase 3 | |||
Abelacimab (MAA868) | Anthos Therapeutics (Novartis spin-out) | Anti-factor XI & XIa MAb | Cancer-associated VTEs: ph3 Aster vs Eliquis & Magnolia vs LMW heparin, both complete Sep 2023; ph2 Azalea-TIMI 71 vs Xarelto in AF, data due Q1 2023 |
Phase 2 | |||
Asundexian (BAY 2433334) | Bayer | Oral factor XIa inhibitor | Pacific-AF vs Eliquis, data reported Apr 2022; Pacific-AMI & Pacific-Stroke failed to meet efficacy endpoints |
Milvexian (BMS-986177) | Bristol Myers Squibb/Johnson & Johnson | Oral factor XIa inhibitor | Axiomatic-TKR data positive; Axiomatic-SSP failed to meet efficacy endpoint |
Fesomersen (BAY2976217/IONIS-FXI-LRx) | Ionis | Factor XI antisense | RE-THINc ESRD, in ESRD pts on dialysis, met primary endpoint but Bayer handed back rights Nov 2022 |
Osocimab (BAY1213790) | Bayer/Aronora | Anti-factor XIa MAb | Convert in ESRD pts on dialysis, data due H2 2022 |
MK-2060 | Merck & Co | Anti-Factor XI & XIa MAb | MK-2060-007 in ESRD pts on dialysis, data due H1 2023 |
AB023 | Aronora | Anti-factor XI & XII MAb | Ph2 data published in ESRD pts on dialysis; ph2 ongoing in cancer pts receiving chemo* |
Phase 1 | |||
BMS-986209 | Bristol Myers Squibb | Oral factor XIa inhibitor | Completed ph1 Aug 2021 |
Ir-CPI | Bioxodes | Anti factor XI & XII protein | Completed ph1 Jul 2020 |
*Investigator-sponsored. AF=atrial fibrillation; AMI=acute myocardial infarction; ESRD=end-stage renal disease; SSP=secondary stroke prevention; TKR=total knee replacement; Source: Evaluate Pharma & clinicaltrials.gov. |