Akari begins late-stage trial of nomacopan for Bullous Pemphigoid
Akari Therapeutics is to begin a late-stage trial of nomacopan, its potential therapy for Bullous Pemphigoid, the rare autoimmune skin disorder.
The company based in New York and London has clearance from the FDA to start development of the drug, with clinical sites due to open midway through this year.
BP may last several years and in the absence of treatment has a tendency to relapse, and is most common in the elderly.
There is no treatment specifically approved to treat symptoms including blisters, hives and itching.
Instead doctors resort to treating the symptoms with potent oral steroids for six months or more, which can bring unpleasant side effects and a three-fold or larger increase in mortality.
The disease affects around one in 120,000 patients in the US and EU with moderate and severe patients making up around three quarters of the patient population.
According to Akari nomacopan’s ability to inhibit C5 and LTB4 gives a potential therapeutic advantage over other potential therapies such as cytokine inhibitors.
The company thinks that the therapy could have a dual action that is further up the inflammatory pathways that are linked with the disease.
In a phase 2 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.
In a pre-clinical model 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.
Akari’s pivotal phase 3 trial design involves a randomised placebo-controlled study with nomacopan in patients with moderate to severe BP with a primary endpoint of disease remission on minimal oral corticosteroids.
It was based on the company’s end-of-phase 2 meetings held last year with both the FDA and the European Medicines Agency.