Akari Therapeutics, Plc (Nasdaq: AKTX) a clinical-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases, confirmed that the U.S. Food and Drug Administration has granted Fast Track designation to nomacopan to treat patients affected with BP. AKTX stock surged adjacent to the news.
At last check-in current trading, shares of Akari Therapeutics Plc (AKTX) were up 3.85% at $2.43. The price range of the company’s shares was between $2.31 and $2.38. It traded 9.19 million shares, which was above its daily average of 0.39 million shares over 100 days. The company had an earnings per share ratio of -0.63.
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About Akari Therapeutics
Nomacopan has seen fast track to facilitate the development and treatment of serious conditions such as BP, and provide the patient with the drug as early as possible. Nomacopan receiving Fast Track could provide repeated meetings with FDA to review the drug’s development plan which may be inclusive of the design of the proposed clinical trials, and adequate data required for further approval.
A positive result to treat BP could potentially open up various other dermatological illnesses for treatment with nomacopan, including hidradenitis suppurativa, epidermolysis bullosa acquisita, and mucous membrane pemphigoid. Akari’s leading drug, Nomacopan is a C5 complement inhibitor that particularly binds to and inhibits leukotriene B4 (LTB4) activity.
BP is a severe orphan autoimmune disease that causes blistering and has no approved methods of treatment in the US and Europe. The disease especially targets the elderly and firsthand treatment includes steroids and immunosuppressants for six months which may cause several side effects and a threefold increase in mortality in the BP-treated demographic.
BP is expected to have almost 120,000 patients in U.S. and EU5 with 75% of the patient population consisting of moderate and severe cases. In BP patients no adequate evidence is present that terminal complement activation has a major role in driving the illness. Furthermore, FDA approval of the Investigational New Drug Application (IND) allows clinical facilities to open in U.S. and Europe in mid-2021.
Conclusion
FDA approval of Akari Therapeutics manufactured drug nomacopan has peaked investor interest with AKTX surging at last check. Fast track of the drug may open several avenues for treatment of several diseases with most patients reporting moderate to severe cases.