Endpoint Health receives exclusive rights to develop and commercialize Grifols’ Antithrombin III to treat sepsis

Endpoint Health to receive up to $25 million for clinical development

The companies will jointly fund an expansion to manufacturing capacity upon FDA Approval

Palo Alto, Calif. – February 24, 2022 – Endpoint Health, Inc., a precision-first^TM therapeutics company dedicated to addressing urgent needs in immune-driven critical and chronic illnesses, today announced that the company has entered into a global collaboration and licensing agreement with Grifols, a leading global producer of plasma-derived medicines, under which Endpoint Health will receive exclusive rights to develop and commercialize Antithrombin III (AT-III) in sepsis.

Under the terms of the agreement, Grifols will provide up to $25 million to support the clinical development of Antithrombin III in sepsis. Endpoint Health plans to submit its Investigational New Drug (IND) Application and Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA) later this year for a Phase II clinical trial of Antithrombin III. The trial is intended to investigate the use of Antithrombin III in patients with sepsis and the capability of identifying patients who are most likely to respond to the therapy when it is used in conjunction with Endpoint Health’s investigational companion diagnostic, which was developed using the company’s proprietary AI platform.

Endpoint Health gains exclusive rights to Antithrombin III in sepsis in all countries, except for China, and will be responsible for all future clinical development, as well as regulatory submissions and commercialization in the disease state. Grifols will be responsible for all manufacturing and product supply. Upon FDA approval, both companies will jointly fund an expansion to Antithrombin III manufacturing capacity. Grifols will receive royalty payments following industry-standard royalty rates in line with the nature of the project and based on Endpoint Health’s future net sales, as well as associated product transfer revenues.

“This collaboration agreement is a major step forward in Endpoint Health’s journey to develop and commercialize new precision therapies for 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, which analyzes omics and health record data to identify biologically distinct patient substates that have the potential for differential treatment response. With our unique understanding of patient biology, we believe Endpoint Health has the potential to transform the standard of care in immune-driven illnesses.”

“This alliance exemplifies Grifols’ commitment to developing innovative therapeutics based on its proven capabilities in plasma-derived therapies, and its deep understanding of the mechanisms of action through which Antithrombin III affects human health,” said Víctor Grifols Deu, co-CEO of Grifols. “We look forward to exploring how our antithrombin might help patients suffering from sepsis.”

According to the World Health Organization, sepsis is considered 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 accounts for almost 20% of all global deaths.¹  

“Despite the life-threatening and debilitating nature of immune-driven illnesses such as sepsis, advances in precision immunology lag behind other areas of medicine,” said Diego Rey, co-founder and Chief Scientific Officer of Endpoint Health. “Endpoint Health’s precision-first therapeutic approach enables us to identify therapies that we can rapidly move into clinical development. We look forward to initiating our Phase 2 trial for Antithrombin III in sepsis, an area where new treatments are desperately needed.”

About Antithrombin

Antithrombin from Grifols is the only human plasma-derived product available in the US market for the treatment of hereditary antithrombin deficiency, an inherited blood clotting disorder. It is also approved and marketed for this indication in Canada, Argentina and Hong Kong. Research has shown that sepsis may cause coagulation disorder, a rare but serious condition that causes abnormal blood clotting throughout the body’s blood vessels that may damage and destroy tissues and lead to bleeding due to the consumption of coagulation factors.²

About Sepsis

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.

About Endpoint Health

Endpoint Health is a precision-first therapeutics company dedicated to addressing urgent needs in immune-driven critical and chronic illnesses by building a pipeline of therapies designed to personalize treatment to each patient’s biology. We combine therapeutics, therapy-guiding tests, and AI to develop targeted therapies for patients with inflammatory illnesses, such as acute respiratory distress syndrome (ARDS), sepsis, rheumatoid arthritis, and inflammatory bowel disease. Our vision is a world in which all patients get the best treatment possible for their unique biology and disease. For more information, visit www.endpointhealth.com.

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About Grifols

Grifols is a global healthcare company founded in Barcelona in 1909, committed to improving the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services that are sold in more than 100 countries.

Pioneers in the plasma industry, Grifols operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat chronic, rare and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. For more information, please visit www.grifols.com.

Contact

Christian Pflaumer
Ruder Finn
917.841.4525

[email protected]

References

1. World Health Organization, Accessed at https://www.who.int/news-room/fact-sheets/detail/sepsis
2. Current Opinion in Anesthesiology, Accessed at https://journals.lww.com/co-anesthesiology/Abstract/2015/04000/The_coagulopathy_of_acute_sepsis.18.aspx