Coagulant Therapeutics Announces Publication of In Vivo Data Demonstrating the Safety and Efficacy of CT-001 for the Management of Acute Bleeding

The short duration of FVIIa-enhanced procoagulant activity provided by CT-001 has the potential to be an optimal paradigm for the treatment of acute bleeding

CT-001 to be evaluated as a treatment for severe postpartum hemorrhage

SAN FRANCISCO, July 7, 2022 /PRNewswire/ — Coagulant Therapeutics Corporation, a privately held company focused on the design, development and commercialization of therapeutics targeting the coagulation cascade and its adjacencies, today announced the results of live studies for its lead product candidate, CT-001, published in the July 2022 magazine edition, Thrombosis Research.

The manuscript, titled “CT-001 Is a Rapid Clearing Factor VIIa with Enhanced Clearance and Hemostatic Activity for the Treatment of Acute Bleeding in Non-Hemophilia Settings”, showed that CT-001 is a safe and effective treatment for acute bleeding. CT-001 is a next-generation factor VIIa (FVIIa) therapy, a recombinant and activated version of coagulation factor, Factor VII, which is found naturally in the body and plays a key role in stopping bleeding. CT-001 was designed to limit its circulating half-life to only three (3) minutes compared to a half-life of two (2) hours for wild-type (WT) FVIIa. This acceleration of clearance time from the body leads to improved safety in thrombogenicity models. Additionally, CT-001 was engineered to have an increased affinity with the cell surface, resulting in increased activity. This results in superior efficacy in an acute bleeding model compared to recombinant FVIIa.

“Uncontrolled bleeding is the leading cause of death in people aged 1 to 44. CT-001 has the potential to become the new standard of care for treating acute bleeding,”¹ said Terry Hermistondoctorate, founder and CEO of Coagulant Therapeutics. “We believe that up to 40% of bleeding-related deaths could be prevented with the kind of rapid hemostatic control demonstrated by CT-001.”^2.3

Engineering of an improved FVII molecule: Characterization and validation in vivo

The live studies have compared the safety and efficacy of CT-001 versus recombinant FVIIa in several mouse models. The studies confirmed that desialylation of the molecule increased the rate at which it was eliminated from the body. The resulting shortened half-life translated into reduced pathological thrombogenicity relative to conventional recombinant FVIIa in two models of thrombosis. These studies also tested the efficacy of the CT-001 molecule, engineered in the Gla domain (gamma-carboxyglutamic acid, an amino acid sequence of FVII responsible for binding to the site of injury) for targeting and potency. enhanced to compensate for rapid clearance. In a mouse model of acute hemorrhage, CT-001 prevented mice from progressing to severe hemorrhage even with increased clearance and demonstrated superiority over the native FVIIa molecule. The live studies have also confirmed the results of a 2021 study of CT-001 in in vitro systems published in the journal Research and practice in thrombosis and hemostasiswhich demonstrated the rapid clearance and increased potency of CT-001 compared to recombinant FVIIa.[4]

“We believe these studies support the potential utility of CT-001 in acute bleeding settings where there are currently no approved pharmaceutical therapies. We are preparing for a Phase 1 clinical trial in the initial indication of bleeding severe postpartum, an indication of significant unmet medical need for which we recently obtained orphan drug designation,” said Hermiston.

About CT-001

CT-001 is a technical version of FVIIa designed to address the limitations of recombinant FVIIa, approved for use in patients with hemophilia A and B with inhibitors, congenital factor VII (FVII) deficiency and Glanzmann’s thrombasthenia with refractory to platelet transfusions, but not approved for use in acute bleeding settings such as trauma, traumatic brain injury, intracranial hemorrhage, or severe postpartum hemorrhage. To improve safety and to address the risk of unwanted clotting with FVIIa, CT-001 was designed for rapid blood clearance. This feature reduces the time an individual is exposed to pro-coagulant activity, which reduces the risk of thromboembolic events. To improve efficacy, while compensating for the rapid elimination of CT-001 from the blood, the molecule was also designed to target the site of bleeding more effectively than conventional FVIIa, with a resultant increase in activity. CT-001 was originally developed by Dr. Hermiston while he was Vice President of Biologics at Bayer AG and later acquired by the company. CT-001 is currently being studied for the treatment of severe postpartum hemorrhage.

[1] Centers for Disease Control and Prevention, National Center for Injury Prevention and Control

[2] Tisherman SA et al., Detailed Description of All Deaths in Resuscitation Outcomes Consortium Hypertonic Saline Shock and Traumatic Brain Injury Trials. Ann Surg 2015 261:586-590.

[3] Spinella PC et al, Prehospital hemostatic resuscitation to achieve zero preventable deaths after traumatic injury. Curr Opin Hematol 2017 24:529-535.

[4] Sim DS et al., In vitro characterization of CT-001 – a short-acting factor VIIa with enhanced prohaemostatic activity. Res Practice Thromb Haemost 2021 5:e12530.

About Coagulant Therapeutics Corporation

Coagulant therapy is a private company focused on the design, development and commercialization of therapeutic products targeting the coagulation cascade and its contiguities. The company’s lead product candidate, CT-001, is a next-generation factor VIIa designed for increased efficacy and safety in acute bleeding. Coagulant is also developing additional therapies for the treatment of acute bleeding and other diseases related to the coagulation cascade. Founded in 2019, the company is based in Berkeley, California. For more information, please visit www.coagulanttherapeutics.com.

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SOURCE Coagulant Therapeutics Corporation