Akari Therapeutics has reported positive results from an ongoing Phase II clinical trial assessing nomacopan for the treatment of an autoimmune inflammatory skin disease called bullous pemphigoid (BP).
Nomacopan is designed to inhibit both C5 complement and leukotriene B4 (LTB4) activity.
The company said that data from BP patients has shown the potential benefits of the dual inhibition of C5 and LTB4.
Analysis of participants’ blister fluid revealed quantities of C5a and LTB4 that trigger in-vitro recruitment of granulocytes, which are associated with disease progression.
In addition, the number of cells that express C5 and LTB4 G-protein coupled receptors were found to be significantly higher in perilesional skin than healthy control skin.
Based on this finding, the company believes that targeting the granulocytes recruitment into the skin via the inhibition of C5 and LTB4 may help treat pemphigoid diseases.
Results from the initial three patients in the Phase II trial showed a rapid decrease in BP Disease Area Index (BPDAI) score and blistering when treated with nomacopan.
No drug-related serious adverse events were observed, comparable to data from other patients who systemically received nomacopan for a total of nearly 20 cumulative patient-years.
Akari Therapeutics chief scientific officer Miles Nunn said: “Both C5a and LTB4, which are inhibited by nomacopan, have central roles in the recruitment and activation of granulocytes, and in BP are responsible for the formation of blisters at sites of autoantibody deposition.
“The encouraging data of Dr Sadik and colleagues provides further support for the potential for the combined inhibition of C5 and LTB4 by nomacopan to provide a major therapeutic advantage in BP and other autoimmune diseases.”
The company also reported that nomacopan more effectively reduced disease in a murine model of pemphigoid diseases when compared to L-nomacopan, which only blocks LTB4.