On Thursday, shares of biopharmaceutical company Akari Therapeutics (AKTX - Free Report) are skyrocketing, up over 60% in midday trading—the stock was up 90% in premarket trading—after it announced it would advance its lead drug candidate.
In a press release, Akari said that after an End-of-Phase 2 meeting with the FDA and based on the agency’s feedback, the company would be pushing forward Coversin into Phase 3 development for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in the first quarter of 2018.
In the U.S., the PNH indication has “Fast Track” status. PNH is a rare, life-threatening disease of the blood; it’s characterized by the destruction of red blood cells, blood clots, and impaired bone marrow function. PNH affects about 1 to 1.5 persons per million, and primarily impacts younger adults, according to Johns Hopkins.
“Following our recent FDA meeting, we are working to initiate a Phase III clinical trial of Coversin in PNH in Q1 2018,” said Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics. “We will continue to work closely with the FDA, benefitting from our Fast Track status in the U.S., and with the EMA towards submission of a BLA and MAA, respectively, for Coversin in PNH.”
Akari said that it plans to perform two Phase 3 clinical studies, CAPSTONE and ASSET. CAPSTONE will carry out on “naïve” PNH patients where Alexion’s (ALXN - Free Report) Soliris, or eculizumab, is not the standard of care, while ASSET is a Phase 3 clinical study that switches PNH patients from eculizumab to treatment with Coversin.
With Coversin delivered subcutaneously, patients may have greater independence due to self-administration. Phase II studies are also planned for a number of other indications where Coversin’s actions on both the complement and leukotriene (LTB4) pathways play a role. Its two leading targets in this area are atopic keratoconjunctivitis (AKC), a rare eye disorder and severe bullous pemphigoid (BP), a rare skin disorder,” added Solomon.
Akari focuses on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. The stock is a #1 (Strong Buy) on the Zacks Rank, with a VGM Score of ‘F.’
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