Bayer drops an Ionis-partnered drug after sinking $240M into its development

04 Nov 2022
endpts.com
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Bayer is punting an Ionis Pharmaceuticals-partnered drug back to the biotech, giving up on a program on which it had spent more than $200 million.
The German pharma company is washing its hands of the Ionis-developed fesomersen, a spokesperson confirmed to Endpoints News, despite having invested $240 million as part of a 2015 licensing deal. Bayer spokesperson Pamela Cohen told Endpoints the move “follows our company’s decision to focus on the further development of asundexian,” a blood thinner on the verge of Phase III studies.
Asked if anything about the drug’s risk-benefit profile factored into the move, Cohen said simply, “Bayer made the business decision to return fesomersen to Ionis.”
In a press release, Ionis said it plans to search for a new fesomersen partner.
Ionis developed fesomersen, an antisense therapy designed to reduce factor XI levels in the liver and prevent blood clots, and teamed up with Bayer for $100 million upfront back in 2015. Bayer also shelled out $55 million in then-near-term payments to advance the drug into Phase II studies, another $75 million in 2017 when it moved into Phase IIb and $10 million in 2019.
Asundexian, the factor XIa program Bayer has chosen to focus on instead, has had a bumpy ride this year. Though a Lancet paper published in April indicated the drug appeared to reduce blood clots at a rate higher than the standard-of-care Eliquis, sold by Bristol Myers Squibb, data presented at ESC in August revealed it missed the efficacy mark in two Phase II studies.
Like its rivals, however, Bayer is charging into Phase III after blaming the mid-stage failures on the larger incidence of brain infarcts, which manifests as ischemic strokes and are detected by MRI imaging. Execs from Bristol Myers and J&J, developing a next-gen factor XIa candidate together in milvexian, told Kyle LaHucik at ESC that the MRI aspect of the composite primary endpoint is “actually not as good as a biomarker for real stroke as was hypothesized.”
#ESC22: BMS-J&J’s milvexian misses composite endpoint, but duo to push drug forward with signs of secondary stroke prevention and ‘flat bleeding curve’
Bayer execs are banking on data showing reduced secondary symptomatic stroke as reason to advance into pivotal studies, as researchers also saw no statistically significant improvement for asundexian MRI imaging. Phase III studies are still expected to begin before the end of the year, Cohen told Endpoints.
Friday’s news comes as Ionis announced fesomersen achieved its primary goal in a Phase IIb study. The drug was being tested in more than 300 patients with end-stage renal disease who were also on hemodialysis.
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