NEW YORK, NY, USA and LONDON, UK I March 31, 2016 I Akari Therapeutics (AKTX), an emerging growth, development-stage biopharmaceutical company, announced today preliminary results from the first paroxysmal nocturnal hemoglobinuria (PNH) patient treated with subcutaneously administered Coversin. The patient, diagnosed with PNH and resistant to eculizumab due to a polymorphism was started on Coversin under a clinical trial protocol approved by a EU national regulatory authority for treating PNH patients with eculizumab resistance. On Coversin therapy, administered subcutaneously, the patient demonstrated clinical and symptomatic improvement, complement inhibition (as measured by the CH50 assay) and a marked reduction of LDH (a marker of blood hemolysis). The patient will continue self-injection as per the protocol. Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).
“To our knowledge, this is the first eculizumab resistant PNH patient treated to date and we are pleased with these preliminary signs of effectiveness,” said Wynne Weston-Davies, Medical Director of Akari Therapeutics. “Based on these preliminary results, we believe that all PNH patients with or without resistance should respond to Coversin.”
The primary objective of the eculizumab-resistance clinical trial is to provide patients who have clinically demonstrated resistance to eculizumab early access to Coversin as a potentially lifesaving alternative. These patients are entered into an open label protocol where safety and efficacy are measured on an ongoing basis. Data from patients in this trial will be presented at future scientific forums.
About Akari Therapeutics Plc
Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. Akari’s lead drug, Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).
SOURCE: Akari Therapeutics
Post Views: 122
NEW YORK, NY, USA and LONDON, UK I March 31, 2016 I Akari Therapeutics (AKTX), an emerging growth, development-stage biopharmaceutical company, announced today preliminary results from the first paroxysmal nocturnal hemoglobinuria (PNH) patient treated with subcutaneously administered Coversin. The patient, diagnosed with PNH and resistant to eculizumab due to a polymorphism was started on Coversin under a clinical trial protocol approved by a EU national regulatory authority for treating PNH patients with eculizumab resistance. On Coversin therapy, administered subcutaneously, the patient demonstrated clinical and symptomatic improvement, complement inhibition (as measured by the CH50 assay) and a marked reduction of LDH (a marker of blood hemolysis). The patient will continue self-injection as per the protocol. Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).
“To our knowledge, this is the first eculizumab resistant PNH patient treated to date and we are pleased with these preliminary signs of effectiveness,” said Wynne Weston-Davies, Medical Director of Akari Therapeutics. “Based on these preliminary results, we believe that all PNH patients with or without resistance should respond to Coversin.”
The primary objective of the eculizumab-resistance clinical trial is to provide patients who have clinically demonstrated resistance to eculizumab early access to Coversin as a potentially lifesaving alternative. These patients are entered into an open label protocol where safety and efficacy are measured on an ongoing basis. Data from patients in this trial will be presented at future scientific forums.
About Akari Therapeutics Plc
Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. Akari’s lead drug, Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).
SOURCE: Akari Therapeutics
Post Views: 122
