Benzinga | Apr 12, 2021 12:48PM EDT

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 (NASDAQ: 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.