Endpoint Well being Enters into International Collaboration and Licensing Settlement with Grifols

Endpoint Well being receives unique rights to develop and commercialize Grifols’ Antithrombin III to deal with sepsis

Endpoint Well being to obtain as much as $25 million for scientific improvement

The businesses will collectively fund an enlargement to manufacturing capability upon FDA Approval

PALO ALTO, Calif., February 24, 2022–(BUSINESS WIRE)–Endpoint Well being, Inc., a precision-firstTM therapeutics firm devoted to addressing pressing wants in immune-driven crucial and continual diseases, at the moment introduced that the corporate has entered into a world collaboration and licensing settlement with Grifols, a number one international producer of plasma-derived medicines, underneath which Endpoint Well being will obtain unique rights to develop and commercialize Antithrombin III (AT-III) in sepsis.

Underneath the phrases of the settlement, Grifols will present as much as $25 million to assist the scientific improvement of Antithrombin III in sepsis. Endpoint Well being plans to submit its Investigational New Drug (IND) Software and Investigational System Exemption (IDE) to the US Meals and Drug Administration (FDA) later this 12 months for a Part II scientific trial of Antithrombin III. The trial is meant to research using Antithrombin III in sufferers with sepsis and the aptitude of figuring out sufferers who’re most definitely to reply to the remedy when it’s used together with Endpoint Well being’s investigational companion diagnostic, which was developed utilizing the corporate’s proprietary AI platform.

Endpoint Well being features unique rights to Antithrombin III in sepsis in all international locations, aside from China, and can be answerable for all future scientific improvement, in addition to regulatory submissions and commercialization within the illness state. Grifols can be answerable for all manufacturing and product provide. Upon FDA approval, each corporations will collectively fund an enlargement to Antithrombin III manufacturing capability. Grifols will obtain royalty funds following industry-standard royalty charges consistent with the character of the mission and primarily based on Endpoint Well being’s future internet gross sales, in addition to related product switch revenues.

“This collaboration settlement is a serious step ahead in Endpoint Well being’s journey to develop and commercialize new precision therapies for sufferers with crucial and continual immune-driven diseases,” stated Jason Springs, co-founder and Chief Government Officer of Endpoint Well being. “We recognized Antithrombin III as a doubtlessly promising remedy for sepsis utilizing our proprietary AI platform, which analyzes omics and well being file knowledge to establish biologically distinct affected person substates which have the potential for differential remedy response. With our distinctive understanding of affected person biology, we consider Endpoint Well being has the potential to remodel the usual of care in immune-driven diseases.”

“This alliance exemplifies Grifols’ dedication to growing revolutionary therapeutics primarily based on its confirmed capabilities in plasma-derived therapies, and its deep understanding of the mechanisms of motion via which Antithrombin III impacts human well being,” stated Víctor Grifols Deu, co-CEO of Grifols. “We stay up for exploring how our antithrombin would possibly assist sufferers affected by sepsis.”

In response to the World Well being Group, sepsis is taken into account a world well being risk as a result of it’s ceaselessly a last frequent pathway to demise from many infectious ailments, together with COVID-19. Yearly, there are an estimated 48.9 million instances and 11 million sepsis-related deaths worldwide, which accounts for nearly 20% of all international deaths.1

“Regardless of the life-threatening and debilitating nature of immune-driven diseases corresponding to sepsis, advances in precision immunology lag behind different areas of medication,” stated Diego Rey, co-founder and Chief Scientific Officer of Endpoint Well being. “Endpoint Well being’s precision-first therapeutic method allows us to establish therapies that we are able to quickly transfer into scientific improvement. We stay up for initiating our Part 2 trial for Antithrombin III in sepsis, an space the place new therapies are desperately wanted.”

About Antithrombin

Antithrombin from Grifols is the one human plasma-derived product out there within the US marketplace for the remedy of hereditary antithrombin deficiency, an inherited blood clotting dysfunction. Additionally it is authorised and marketed for this indication in Canada, Argentina and Hong Kong. Analysis has proven that sepsis could trigger coagulation dysfunction, a uncommon however critical situation that causes irregular blood clotting all through the physique’s blood vessels which will injury and destroy tissues and result in bleeding as a result of consumption of coagulation components.2

About Sepsis

Sepsis happens when the physique’s immune response to an an infection turns into dysregulated. This could trigger a cascade of adjustments that injury a number of organ programs, main them to fail, generally even leading to demise.

About Endpoint Well being

Endpoint Well being is a precision-first therapeutics firm devoted to addressing pressing wants in immune-driven crucial and continual diseases by constructing a pipeline of therapies designed to personalize remedy to every affected person’s biology. We mix therapeutics, therapy-guiding assessments, and AI to develop focused therapies for sufferers with inflammatory diseases, corresponding to acute respiratory misery syndrome (ARDS), sepsis, rheumatoid arthritis, and inflammatory bowel illness. Our imaginative and prescient is a world wherein all sufferers get the perfect remedy doable for his or her distinctive biology and illness. For extra data, go to www.endpointhealth.com.

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About Grifols

Grifols is a world healthcare firm based in Barcelona in 1909, dedicated to enhancing the well being and well-being of individuals world wide. Its 4 divisions – Bioscience, Diagnostic, Hospital and Bio Provides – develop, produce and market revolutionary options and companies which might be offered in additional than 100 international locations.

Pioneers within the plasma {industry}, Grifols operates a rising community of donation facilities worldwide. It transforms collected plasma into important medicines to deal with continual, uncommon and, at instances, life-threatening situations. As a acknowledged chief in transfusion drugs, Grifols additionally affords a complete portfolio of options designed to reinforce security from donation to transfusion. As well as, the corporate provides instruments, data and companies that allow hospitals, pharmacies and healthcare professionals to effectively ship professional medical care. For extra data, please go to www.grifols.com

References

  1. World Well being Group, Accessed at https://www.who.int/news-room/fact-sheets/element/sepsis

  2. Present Opinion in Anesthesiology, Accessed at https://journals.lww.com/co-anesthesiology/Summary/2015/04000/The_coagulopathy_of_acute_sepsis.18.aspx

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Contacts

Christian Pflaumer
Ruder Finn
917.841.4525
[email protected]

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