In vivo data suggests that CT-001, a short duration of highly active FVIIa procoagulant, has the potential to be an optimal treatment for acute bleeds.
CT-001 has also received orphan-drug designation for treatment for postpartum hemorrhage
SAN FRANCISCO, CA, USA I July 12, 2022 I Coagulant Therapeutics Corporation, a privately held company focused on the research, development and commercialization of therapeutics targeted to the coagulation cascade and its adjacencies, announced data from in vivo pre-clinical studies of its lead investigational candidate CT-001. CT-001 is the only engineered FVIIa therapy under development to treat postpartum hemorrhage. These data were shared during a poster presentation (abstract number PB1003; July 12 Tuesday, 2022) at the International Society on Thrombosis and Haemostasis (ISTH) in London, July 9-13, 2022.
Dr. Derek Sim, Chief Scientific Officer of Coagulant Therapeutics, suggests that these data demonstrate that a FVIIa molecule engineered to be both safer and more active than recombinant FVIIa (rFVIIa) may be an effective treatment for acute bleeding.
Gla (gamma-carboxyglutamic acid) domain engineering increases the activity of CT-001 2-5 fold over rFVIIa. To reduce unwanted thromboembolic events that have been described for the rFVIIa molecule, Coagulant also applied desialylation to the molecule. This process exposes galactose residues on the molecule for recognition and active clearance by the asialoglycoprotein receptor, which reduces the circulation time in the body from 2 hours down to 3 minutes. This reduced circulation time resulted in significant reduction in thrombogenicity risk in 2 mouse models. Importantly, the combination of superior activity and shorter circulation time of CT-001 translated into superior efficacy in mouse models of acute bleeding.
“We are excited to present our data at ISTH and to further engage the scientific and clinical communities around our molecule and its application to acute bleeding,” said Terry Hermiston, Ph.D., founder and CEO of Coagulant Therapeutics. “Our goal is to advance CT-001 to the clinic as a new treatment for severe postpartum hemorrhage, a growing problem and a significant factor in maternal morbidity and mortality not only in the US but globally.”
The Company also announced that the U.S. Food and Drug Administration (FDA) has granted CT-001orphan drug status as a human recombinant factor VIIa variant, desialylated for the treatment of postpartum hemorrhage.
About CT-001
CT-001 is an engineered version of clotting factor FVIIa that is designed to address the safety and efficacy limitations of the recombinant FVIIa(rFVIIa). Recombinant FVIIa is currently approved for use in Hemophilia A and B patients with inhibitors, congenital FVII deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, however rFVIIa is not currently approved for use in acute bleeding settings such as trauma, traumatic brain injury, intracranial hemorrhage or severe postpartum hemorrhage. To improve safety and address the unwanted clotting risk associated with rFVIIa, CT-001 was engineered for rapid clearance from the blood. This feature reduces the time during which an individual is exposed to pro-coagulant activity, and therefore 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. This targeting results in increased activity. CT-001 was originally developed by Dr. Hermiston during his tenure as Vice President of Biologics at Bayer AG and was subsequently acquired from Bayer by the Company. CT-001 is currently under investigation for treatment of severe postpartum hemorrhage.
About Coagulant Therapeutics Corporation
Coagulant Therapeutics is a privately held company focused on the research, 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 for the treatment of acute bleeding and other coagulation cascade-related diseases. Founded in 2019, the company is based in Berkeley, California. For more information about Coagulant Therapeutics, please visit www.coagulanttherapeutics.com.
SOURCE: Coagulant Therapeutics
Post Views: 48
In vivo data suggests that CT-001, a short duration of highly active FVIIa procoagulant, has the potential to be an optimal treatment for acute bleeds.
CT-001 has also received orphan-drug designation for treatment for postpartum hemorrhage
SAN FRANCISCO, CA, USA I July 12, 2022 I Coagulant Therapeutics Corporation, a privately held company focused on the research, development and commercialization of therapeutics targeted to the coagulation cascade and its adjacencies, announced data from in vivo pre-clinical studies of its lead investigational candidate CT-001. CT-001 is the only engineered FVIIa therapy under development to treat postpartum hemorrhage. These data were shared during a poster presentation (abstract number PB1003; July 12 Tuesday, 2022) at the International Society on Thrombosis and Haemostasis (ISTH) in London, July 9-13, 2022.
Dr. Derek Sim, Chief Scientific Officer of Coagulant Therapeutics, suggests that these data demonstrate that a FVIIa molecule engineered to be both safer and more active than recombinant FVIIa (rFVIIa) may be an effective treatment for acute bleeding.
Gla (gamma-carboxyglutamic acid) domain engineering increases the activity of CT-001 2-5 fold over rFVIIa. To reduce unwanted thromboembolic events that have been described for the rFVIIa molecule, Coagulant also applied desialylation to the molecule. This process exposes galactose residues on the molecule for recognition and active clearance by the asialoglycoprotein receptor, which reduces the circulation time in the body from 2 hours down to 3 minutes. This reduced circulation time resulted in significant reduction in thrombogenicity risk in 2 mouse models. Importantly, the combination of superior activity and shorter circulation time of CT-001 translated into superior efficacy in mouse models of acute bleeding.
“We are excited to present our data at ISTH and to further engage the scientific and clinical communities around our molecule and its application to acute bleeding,” said Terry Hermiston, Ph.D., founder and CEO of Coagulant Therapeutics. “Our goal is to advance CT-001 to the clinic as a new treatment for severe postpartum hemorrhage, a growing problem and a significant factor in maternal morbidity and mortality not only in the US but globally.”
The Company also announced that the U.S. Food and Drug Administration (FDA) has granted CT-001orphan drug status as a human recombinant factor VIIa variant, desialylated for the treatment of postpartum hemorrhage.
About CT-001
CT-001 is an engineered version of clotting factor FVIIa that is designed to address the safety and efficacy limitations of the recombinant FVIIa(rFVIIa). Recombinant FVIIa is currently approved for use in Hemophilia A and B patients with inhibitors, congenital FVII deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, however rFVIIa is not currently approved for use in acute bleeding settings such as trauma, traumatic brain injury, intracranial hemorrhage or severe postpartum hemorrhage. To improve safety and address the unwanted clotting risk associated with rFVIIa, CT-001 was engineered for rapid clearance from the blood. This feature reduces the time during which an individual is exposed to pro-coagulant activity, and therefore 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. This targeting results in increased activity. CT-001 was originally developed by Dr. Hermiston during his tenure as Vice President of Biologics at Bayer AG and was subsequently acquired from Bayer by the Company. CT-001 is currently under investigation for treatment of severe postpartum hemorrhage.
About Coagulant Therapeutics Corporation
Coagulant Therapeutics is a privately held company focused on the research, 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 for the treatment of acute bleeding and other coagulation cascade-related diseases. Founded in 2019, the company is based in Berkeley, California. For more information about Coagulant Therapeutics, please visit www.coagulanttherapeutics.com.
SOURCE: Coagulant Therapeutics
Post Views: 48
