Bayer/Ionis Advance Next-Generation Antithrombotic After Positive Clinical Results
And Bayer Sets Up Artificial Intelligence Center In The UK
Executive Summary
In a collaboration with Ionis Pharmaceuticals, Bayer is pressing ahead with Phase II clinical studies of an antisense molecule designed to reduce Factor XI production and prevent thrombosis.
An investigational antisense product, IONIS-FXI-LRx, is progressing into Phase II studies in a collaboration between Bayer AG and US biotech Ionis Pharmaceuticals Inc., the companies announced on 9 October.
The move follows positive clinical results with the product, Bayer noted. IONIS-FXI-LRx is designed to reduce the production of the blood clotting factor, Factor XI, in the liver. The company is aiming to develop a next generation of antithrombotic agents which might be associated with little or no bleeding risk.
Germany headquartered Bayer already has a considerable development and commercial experience in antithrombotics with the oral anticoagulant, Xarelto (rivaroxaban), being its top-selling pharmaceutical product. In the first half of 2019, Xarelto had sales of €1.94bn, up by 14% compared with the first half of 2018.
With the move to Phase II, Bayer will be responsible for all development, regulatory and commercialization activities and costs associated with IONIS-FXI-LRx under an agreement signed in 2015 (see sidebar).
Ionis has received more than $185m under that agreement, including a $10m milestone payment it earned with Bayer's continuation decision. The US biotech is eligible to receive additional milestone payments as IONIS-FXI-LRx advances toward the market, as well as tiered royalties in the low to high twenty percent range on gross margins.
Ionis has made significant strides in the scientific understanding of thrombosis formation: "Ionis was first to validate Factor XI and the intrinsic coagulation pathway as a novel antithrombotic strategy,” noted its COO, Brett Monia.
“Our antisense medicine targeting Factor XI demonstrates potent antithrombotic activity with little to no bleeding in multiple patient populations. This enables, for the first time, the potential to separate antithrombotic activity from bleeding risk," Monia added.
High levels of Factor XI increase the risk of blood clot formation inside blood vessels, leading to heart attacks and strokes, while low levels of Factor XI are associated with a lower incidence of thrombosis-related events, but little to no increase in bleeding risk.
IONIS-FXI-LRx has the potential to be used especially in patients at high risk for thrombosis and at high risk of bleeding.
AI Move In The UK
Separately, Bayer announced on 10 October the launch of LifeHub UK, which will drive the development of artificial intelligence (AI) in radiology and imaging in order to detect disease and improve data-driven drug discovery.
It’s the seventh of Bayer’s global network of LifeHubs, and the UK AIM-quoted clinical AI company, Sensyne Health PLC, which entered into a collaboration with Bayer earlier this year, will be one of the first to be involved in the LifeHub, based in Reading’s Green Park. (Also see "Bayer CV Pact Gives AI-Focused Sensyne Health Its First Big Deal Since 2018 IPO " - Scrip, 31 Jul, 2019.)