February 24, 2022
Grifols signs global collaboration agreement with Endpoint Health to develop and commercialize Antithrombin III for Sepsis
- Grifols will be the exclusive supplier of Antithrombin III (AT-III) for treatment of Sepsis, a life-threatening medical emergency
- Endpoint Health expects to submit its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial of Grifols’ Antithrombin III in Sepsis later this year
- Upon FDA approval, the companies will invest to expand existing Antithrombin III production capabilities at Grifols sites
- Grifols strengthens its plasma economics as part of its commitment to drive sustainable growth through innovation
Barcelona, Spain, February 24, 2022 – Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced a collaboration with Endpoint Health, Inc., a precision-medicine therapeutics company dedicated to addressing urgent needs in immune-driven critical care, to develop and commercialize an Antithrombin III (AT-III) therapy to treat Sepsis.
As part of the agreement, Grifols will contribute its industry-leading expertise in plasma-protein therapies and be the exclusive supplier of AT-III, a plasma protein that treats patients with blood clotting issues.
Later this year an Investigational New Drug (IND) application will be submitted to the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial with Grifols’ Antithrombin III. This therapy is the only plasma-protein therapy authorized and approved by the FDA for use in the country to treat Antithrombin III deficiency, an inherited blood-clotting disorder. Grifols has committed to provide up to USD 25 million to support the clinical development program.
As part of the collaboration, and subject to the FDA’s acceptance of its IND and Investigational Device Exemption (IDE) filings, Endpoint Health will deploy its AI technology and its proprietary diagnostic test in a phase II trial designed to identify septic patients mostly likely to respond to AT-III. Upon FDA approval, the companies will invest in a build-out of AT-III production at Grifols sites.
Endpoint Health will manage the clinical development, the subsequent regulatory approval process and commercialization. It will have exclusive development and commercial rights globally, except for China. In addition to any revenues under the AT-III supply agreement, Grifols will receive from Endpoint Health royalties on future net sales.
With this collaboration Grifols strengthens the company’s plasma economics as part of its commitment to drive sustainable growth through innovation.
“Through this global collaboration we hope to see the therapeutic benefit of Antithrombin III combined with precision-medicine diagnostics to treat patients with Sepsis, which we hope will improve patient outcomes,” said Víctor Grifols Deu, co-CEO of Grifols. “Grifols continues to apply its deep knowledge of plasma therapeutic proteins, both through internally inspired innovations and increasingly with external partners, to address serious public health issues.”
“This collaboration agreement is a major step forward to developing new precision therapies to treat patients with critical and chronic immune-driven illnesses,” said Jason Springs, co-founder and Chief Executive Officer of Endpoint Health. “We identified Antithrombin III as a potentially promising treatment for Sepsis using our proprietary AI platform and we believe we can transform the standard of care in immune-driven illnesses.”
Sepsis occurs when the body’s immune response to an infection becomes dysregulated. This can cause a cascade of changes that damage multiple organ systems, leading them to fail, sometimes even resulting in death. The World Health Organization considers Sepsis a global health threat because it is frequently a final common pathway to death from many infectious diseases, including COVID-19. Annually, there are an estimated 48.9 million cases and 11 million Sepsis-related deaths worldwide, which account for almost 20% of all global deaths1.
1World Health Organization, Accessed at https://www.who.int/news-room/fact-sheets/detail/sepsis