Shares of Akari Therapeutics PLC (NASDAQ: AKTX) saw a handy gain on Friday after the firm announced that the U.S. Food and Drug Administration (FDA) granted a Fast Track designation for its treatment of paroxysmal nocturnal hemoglobinuria (PNH). Although Akari does not trade that much on average, this designation is putting the stock on the map.
The drug Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing the release of C5a and the formation of C5b–9 (also known as the membrane attack complex, or MAC), and independently also inhibits LTB4 activity.
The company is evaluating Coversin in two Phase 2 clinical trials. The first Phase 2 trial is evaluating Coversin in patients with PNH who have never received a complement blocking therapy. Interim results from this ongoing Phase 2 trial will be presented at the recently announced Research and Development Day to be held on April 24, 2017, in New York.
The second Phase 2 trial is evaluating Coversin in patients with PNH and C5 polymorphisms resistant to eculizumab. One patient has been enrolled in this trial and has demonstrated significant LDH reduction and complete complement blockade with self-administered subcutaneous Coversin for over one year.
Dr. Gur Roshwalb, CEO of Akari Therapeutics, commented:
We are very proud of the continued advancement of our Coversin program for the treatment of PNH in patients with or without polymorphisms. The FDA fast track designation recognizes the unmet need in patients with PNH who cannot be treated with the current standard of care due to polymorphisms.
Excluding Friday’s move, Akari has underperformed the broad markets in 2017, with the stock down less than 1%. Over the past 52 weeks, the stock is actually down 59.5%.
Shares of Akari were last seen up more than 21% at $8.50 on Friday, with a consensus analyst price target of $19.00 and a 52-week trading range of $6.22 to $19.75.