NEW YORK & LONDON—Akari Therapeutics has announced that the company has entered a cooperative research and development agreement with the US Army Institute of Surgical Research (USAISR). The collaboration will evaluate the potential for use of Akari’s nomacopan in civilian and battlefield trauma injuries for which there are currently no approved therapies, using preclinical trauma and hemorrhages shock models.
“Nomacopan has shown encouraging results in trauma-related conditions — including traumatic brain injury, immune complex-induced acute lung injury, myocardial infarction, and blast injury,” said Dr. Miles Nunn, chief scientific officer of Akari. “The dual inhibition of C5 and leukotriene B4 (LTB4) by nomacopan for the treatment of trauma is supported by a large body of literature reflecting the harmful role for both these inflammatory mediators in the early pathophysiology of trauma and hemorrhagic shock.”
Trauma is a leading cause of death for people 45 and under. In the US, there are approximately 500,000 trauma hospital discharges per year that are defined as severe, and which might benefit from early drug intervention to reduce multi-organ dysfunction following trauma.
“Our lead product candidate nomacopan, a second-generation complement inhibitor, acts on complement component-C5, preventing release of C5a and formation of C5b–9 (also known as the membrane attack complex, or MAC), and independently also inhibits leukotriene B4 activity, both elements that are co-located as part of the immune/inflammatory response,” Akari’s website states. “Additionally, nomacopan’s bio-physical properties allow it to be potentially used in a variety of formulations, including subcutaneous, intravenous, topical or inhaled routes of administration.”
Nomacopan’s dual binding of C5 and LTB4 targets the adverse inflammatory roles of both the complement and leukotriene pathways in trauma. The secondary neuroinflammation and neuronal damage that follows a primary traumatic injury is an important cause of morbidity in affected people, and the role of both pathways are well documented in trauma. This underpins the potential therapeutic benefit of the dual action of nomacopan.
The collaboration intends to focus on preliminary evaluations of biological effects in large animal trauma models. Additional studies will also be required to establish the safety and biological activity of nomacopan in contaminated wound models relevant to battlefield conditions. Nomacopan doesn’t require special handling, can be carried in small vials, and can be quickly reconstituted in small volumes of fluid — these properties may facilitate its use in prehospital settings.
“There are currently no drugs approved for trauma to improve survival and recovery. With nomacopan, Akari’s goal is to make a significant contribution to trauma recovery for the benefit of the US armed forces, as well as to the wider civilian population,” added Clive Richardson, CEO of Akari.
Nomacopan is currently being clinically evaluated in bullous pemphigoid, atopic keratoconjunctivitis, thrombotic microangiopathy, paroxysmal nocturnal hemoglobinuria, and COVID-19 pneumonia.