Akari Therapeutics, Plc (NASDAQ:AKTX) fell Tuesday, a day after the FDA opened the investigational new drug application for Phase 3 trial for Akari Therapeutics lead drug candidate.
Nomacopan was made 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.
BP may last several years in the absence of treatment, has a tendency to relapse and is most common in the elderly. It is primarily treated with potent oral steroids for six months or more which bring with them deleterious side effects and a three-fold or larger increase in mortality.
The prevalence of BP is estimated to be approximately 120,000 patients in U.S. and European Union with moderate and severe patients making up around three quarters of the patient population.
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 treatment of BP.
In the Phase II nomacopan study, patients with BP had elevated levels of LTB4 in their serum and in addition both C5 and LTB4 levels are elevated in blister fluid from BP patients, illustrating the local activation of both these inflammatory pathways.
Moreover, in a pre-clinical model (Sezin et al 2019) the absolute body surface area affected by blisters was reduced by approximately 50% by inhibiting LTB4 alone but by approximately 80% by inhibiting both LTB4 and C5.
AKTX shares retreated 20 cents, or 8.7%, to $2.07.
