Coagulant Therapeutics Presents Data on CT-001 activity in peripartum patient samples at the 2023 Society for Maternal-Fetal Medicine 43rd Annual Pregnancy Meeting

13 Feb 2023
AcquisitionDrug Approval
Poster presentation describes enhanced activity of CT-001 in peripartum patient blood, supporting advancement as a treatment to severe postpartum hemorrhage
SAN FRANCISCO, February 13, 2023 /PRNewswire/ -- Coagulant Therapeutics Corporation, a privately held company focused on the design, development and commercialization of therapeutics targeted to the coagulation cascade and its adjacencies, announced data from pre-clinical studies on CT-001, an FVIIa derivative engineered for superior safety and efficacy in a poster  presentation titled "CT-001, A Novel Next Generation Factor VIIa, Demonstrates Enhanced Procoagulant Activity in Peripartum Patient Samples" at the Society For Maternal-Fetal Medicine 43rd Annual Pregnancy Meeting in San Francisco, California, February 6-11, 2023.
Severe postpartum hemorrhage (PPH) unresponsive to first- and second-line therapies is treated with massive transfusion and aggressive procedures to control blood loss.  Recombinant factor VIIa (rFVIIa) has demonstrated some efficacy but an increased risk of thromboembolism has been reported.  To address this liability, a novel rFVIIa, CT-001, engineered for enhanced activity and rapid clearance was developed.  In previous pre-clinical studies, CT-001 has shown rapid clearance and low thrombogenicity.  In this study, conducted at the Departments of Obstetrics and Gynecology, Duke University, Durham, NC, USA, and Pusan National University School of Medicine, Busan, Rep of Korea, respectively, CT-001 hemostatic activity was assessed ex vivo in peripartum blood samples.
"There are limited therapeutic options and few data from clinical studies to help guide the hemostatic management of severe postpartum hemorrhage, the leading cause of maternal death worldwide.  Our use of CT-001 ex vivo shows promise and opens the door to future clinical studies", said Dr. Andra James, MD, Professor Emeritus of Obstetrics and Gynecology at Duke University, senior author of the study.
"These studies in peripartum blood samples further support the enhanced activity of our novel rFVIIa molecule, CT-001, supporting its advancement to the clinic for the treatment of severe postpartum hemorrhage ," said Terry Hermiston, Ph.D., founder and CEO of Coagulant Therapeutics.
About CT-001
CT-001 is an engineered version of FVIIa that is designed to address the limitations of the recombinant FVIIa (rFVIIa), approved for use in Hemophilia A and B patients with inhibitors, congenital FVII deficiency, and Glanzmann's thrombasthenia with refractoriness to platelet transfusions but not approved for use in the acute bleeding settings such as trauma, traumatic brain injury, intracranial hemorrhage or severe postpartum hemorrhage in the US. To improve safety, and to address the unwanted clotting risk with rFVIIa, CT-001 was engineered for rapid clearance from the blood.  This feature reduces the time in which an individual is exposed to pro-coagulant activity, which reduces the risk of thromboembolic events. To improve efficacy, while compensating for the rapid removal of CT-001 from the blood, the molecule has also been engineered to target the site of bleeding more efficiently and effectively than rFVIIa, with resultant increase in activity.  CT-001 was originally developed by Dr. Hermiston while he served as Vice President of Biologics at Bayer AG and subsequently acquired by the Company.  CT-001 is currently under investigation for treatment of severe postpartum hemorrhage.
Coagulant Therapeutics is a privately held company focused on the design, development and commercialization of therapeutics targeted to the coagulation cascade and its adjacencies. The Company's lead product candidate, CT-001, is a next-generation Factor VIIa designed for enhanced efficacy and safety in the setting of acute bleeding. Coagulant is also developing additional therapeutics targeted to APC for the treatment of acute bleeding and other coagulation cascade-related diseases.  Founded in 2019, the company is based in Berkeley, California.
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