Ionis Pharmaceuticals, the leader in RNA-targeted therapeutics, announced today that the company has been notified by its partner Bayer about the decision to advance IONIS-FXI-LRx following positive clinical results. IONIS-FXI-LRx is an antisense medicine being developed to treat patients with clotting disorders.
IONIS-FXI-LRx utilizes Ionis’ advanced LIgand Conjugated Antisense (LICA) technology platform and is designed to reduce the production of Factor XI (FXI), a clotting factor produced in the liver. High levels of FXI increase the risk of thrombosis and can be responsible for heart attacks and strokes. Alternatively, individuals deficient in FXI have a lower incidence of thrombosis-related events and little to no increase in bleeding risk.
“Ionis was first to validate Factor XI and the intrinsic coagulation pathway as a novel antithrombotic strategy. 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 anti-thrombotic activity from bleeding risk,” said Brett P. Monia, chief operating officer at Ionis. “Considering their vast experience in developing and commercializing medicines to treat thrombosis, along with the significant unmet medical need and the broad market potential for a Factor XI therapy, we believe Bayer is the perfect partner for IONIS-FXI-LRx. Bayer’s decision to advance IONIS-FXI-LRx into a phase 2 clinical trial highlights their confidence in our LICA technology.”
“Bayer and Ionis have a common vision of bringing innovative therapies to patients,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceuticals Division and Head of Research and Development. “We are driving forward the development of our FXI-program and IONIS’ FXI-LRx offers an additional pathway for treating patients for whom there are currently no suitable therapeutic options available.”
In May 2015, Ionis entered into an exclusive license agreement with Bayer to develop and commercialize Ionis’ programs targeting FXI for the treatment of clotting disorders. Under the agreement, Ionis has generated more than $185 million to date, including a $10 million milestone payment Ionis earned with Bayer’s continuation decision. Ionis is eligible to receive additional milestone payments as the medicine advances toward the market, as well as tiered royalties in the low to high twenty percent range on gross margins. Bayer will now assume all development, regulatory and commercialization activities and costs.
Review of the full data package by Ionis and Bayer is ongoing, and the positive clinical results will be presented at an upcoming medical congress.
Source: Company Press Release