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The activated factor VIIa variant according to researchers.
To date, the trial has enrolled five patients with hemophilia A or B and inhibitors. Catalyst would not disclose how many patients have hemophilia A and how many have hemophilia B. Three patients have completed dosing with marzeptacog alfa in a phase 2/3 study. None of these patients experienced bleeding during treatment, and none have developed antidrug antibodies or reported injection site reactions. As for the other two patients enrolled in this study, one withdrew consent, and one died of an adverse event unrelated to marzeptacog alfa.
Howard Levy, chief medical officer of Catalyst Biosciences, which has been developing this drug and sponsored the trial, presented these data at the 2018 Hemophilia Drug Development Summit in Boston.
The goal of this ongoing trial is to determine whether daily subcutaneous injections of marzeptacog alfa can eliminate or minimize spontaneous bleeding episodes. The primary endpoint is a reduction in annualized bleed rate (ABR), compared with each individual’s recorded historical ABR.
One patient with a historic ABR of 26.7 experienced a bleed on day 46 when receiving marzeptacog alfa at 30 mcg/kg but then had no bleeds after 50 days of treatment with marzeptacog alfa at 60 mcg/kg. This patient did experience a bleed 16 days after the end of dosing at 60 mcg/kg.
A second patient with a historic ABR of 16.6 had no bleeds when receiving marzeptacog alfa at 30 mcg/kg for 50 days.
And a third patient with a historic ABR of 15.9 had no bleeds when receiving marzeptacog alfa at 30 mcg/kg for 44 days.
“The data from these 3 individuals support the efficacy of [marzeptacog alfa] to reduce annualized bleed rates after daily subcutaneous injections,” said Nassim Usman, PhD, chief executive officer of Catalyst Biosciences. “Importantly, to date, we have not observed any injection site reactions nor any antidrug antibodies after more than 200 subcutaneous doses of [marzeptacog alfa].”
A fourth patient with a historic ABR of 18.3 had a fatal hemorrhagic stroke on day 11 that was considered unrelated to marzeptacog alfa. The patient had previously treated hypertension that was going untreated at the time of death.
A fifth patient with a historic ABR of 12.2 withdrew consent.
The activated factor VIIa variant according to researchers.
To date, the trial has enrolled five patients with hemophilia A or B and inhibitors. Catalyst would not disclose how many patients have hemophilia A and how many have hemophilia B. Three patients have completed dosing with marzeptacog alfa in a phase 2/3 study. None of these patients experienced bleeding during treatment, and none have developed antidrug antibodies or reported injection site reactions. As for the other two patients enrolled in this study, one withdrew consent, and one died of an adverse event unrelated to marzeptacog alfa.
Howard Levy, chief medical officer of Catalyst Biosciences, which has been developing this drug and sponsored the trial, presented these data at the 2018 Hemophilia Drug Development Summit in Boston.
The goal of this ongoing trial is to determine whether daily subcutaneous injections of marzeptacog alfa can eliminate or minimize spontaneous bleeding episodes. The primary endpoint is a reduction in annualized bleed rate (ABR), compared with each individual’s recorded historical ABR.
One patient with a historic ABR of 26.7 experienced a bleed on day 46 when receiving marzeptacog alfa at 30 mcg/kg but then had no bleeds after 50 days of treatment with marzeptacog alfa at 60 mcg/kg. This patient did experience a bleed 16 days after the end of dosing at 60 mcg/kg.
A second patient with a historic ABR of 16.6 had no bleeds when receiving marzeptacog alfa at 30 mcg/kg for 50 days.
And a third patient with a historic ABR of 15.9 had no bleeds when receiving marzeptacog alfa at 30 mcg/kg for 44 days.
“The data from these 3 individuals support the efficacy of [marzeptacog alfa] to reduce annualized bleed rates after daily subcutaneous injections,” said Nassim Usman, PhD, chief executive officer of Catalyst Biosciences. “Importantly, to date, we have not observed any injection site reactions nor any antidrug antibodies after more than 200 subcutaneous doses of [marzeptacog alfa].”
A fourth patient with a historic ABR of 18.3 had a fatal hemorrhagic stroke on day 11 that was considered unrelated to marzeptacog alfa. The patient had previously treated hypertension that was going untreated at the time of death.
A fifth patient with a historic ABR of 12.2 withdrew consent.
The activated factor VIIa variant according to researchers.
To date, the trial has enrolled five patients with hemophilia A or B and inhibitors. Catalyst would not disclose how many patients have hemophilia A and how many have hemophilia B. Three patients have completed dosing with marzeptacog alfa in a phase 2/3 study. None of these patients experienced bleeding during treatment, and none have developed antidrug antibodies or reported injection site reactions. As for the other two patients enrolled in this study, one withdrew consent, and one died of an adverse event unrelated to marzeptacog alfa.
Howard Levy, chief medical officer of Catalyst Biosciences, which has been developing this drug and sponsored the trial, presented these data at the 2018 Hemophilia Drug Development Summit in Boston.
The goal of this ongoing trial is to determine whether daily subcutaneous injections of marzeptacog alfa can eliminate or minimize spontaneous bleeding episodes. The primary endpoint is a reduction in annualized bleed rate (ABR), compared with each individual’s recorded historical ABR.
One patient with a historic ABR of 26.7 experienced a bleed on day 46 when receiving marzeptacog alfa at 30 mcg/kg but then had no bleeds after 50 days of treatment with marzeptacog alfa at 60 mcg/kg. This patient did experience a bleed 16 days after the end of dosing at 60 mcg/kg.
A second patient with a historic ABR of 16.6 had no bleeds when receiving marzeptacog alfa at 30 mcg/kg for 50 days.
And a third patient with a historic ABR of 15.9 had no bleeds when receiving marzeptacog alfa at 30 mcg/kg for 44 days.
“The data from these 3 individuals support the efficacy of [marzeptacog alfa] to reduce annualized bleed rates after daily subcutaneous injections,” said Nassim Usman, PhD, chief executive officer of Catalyst Biosciences. “Importantly, to date, we have not observed any injection site reactions nor any antidrug antibodies after more than 200 subcutaneous doses of [marzeptacog alfa].”
A fourth patient with a historic ABR of 18.3 had a fatal hemorrhagic stroke on day 11 that was considered unrelated to marzeptacog alfa. The patient had previously treated hypertension that was going untreated at the time of death.
A fifth patient with a historic ABR of 12.2 withdrew consent.