Akari Therapeutics' To Go With Pivotal Bullous Pemphigoid Study With Nomacopan

The FDA has opened the investigational new drug application for Phase 3 trial for Akari Therapeutics Plc's AKTX lead drug candidate, nomacopan, for the treatment of moderate and severe Bullous Pemphigoid (BP), allowing clinical sites to open mid-2021, subject to the ongoing impact of COVID related restrictions.
Akari has been granted orphan drug designation for nomacopan to treat BP by both the FDA and the European Medicines Agency (EMA).
BP is a rare skin condition that causes large, fluid-filled blisters. They develop on skin areas that often flex, such as the lower abdomen, upper thighs, or armpits.
In patients with BP, there is evidence that nomacopan's ability to inhibit C5 and LTB4 gives it a unique potential therapeutic advantage which is upstream of other approaches (such as cytokine inhibitors) that are being investigated for the treatment of BP.
Nomacopan (formerly known as Coversin) is a C5 complement inhibitor that independently and specifically binds to and inhibits leukotriene B4 (LTB4) activity.
Akari's pivotal Phase 3 trial design is a randomized placebo-controlled study with nomacopan in patients with moderate to severe BP with a primary endpoint of disease remission on minimal oral corticosteroids.
Price Action: AKTX shares are down 10.4% at $2.16 in market trading on the last check Monday.