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Akari Therapeutics Receives Approval from the UK Medicines & Healthcare Products Regulatory Agency to Conduct Phase 2 Trial in Paroxysmal Nocturnal Hemoglobinuria

NEW YORK and LONDON, July 13, 2016 (GLOBE NEWSWIRE) -- Akari Therapeutics (NASDAQ:AKTX), an emerging growth, clinical-stage biopharmaceutical company, announced today the approval by the UK Medicines & Healthcare products Regulatory Agency (MHRA) to conduct a Phase 2 trial in patients with paroxysmal nocturnal hemoglobinuria (PNH). Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including paroxysmal nocturnal hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).

This Phase 2 open label trial will study Coversin for 90 days in up to 10 patients with PNH who are not receiving any other complement therapy. The primary endpoint of the trial is the reduction in Lactate Dehydrogenase (LDH), an important blood marker of hemolysis, at day 28. The trial will also explore other endpoints including complement inhibition, LDH throughout the 90 days, as well as measurements of quality of life. At the end of the trial, patients will have the option to continue therapy with Coversin as part of a long term safety study.

“We are very excited to initiate this study and recruit patients,” said Gur Roshwalb, Chief Executive Officer of Akari Therapeutics. “We believe the data from this Phase 2 study in PNH will further the positive results previously reported from our Phase 2 eculizumab resistance study, and our Phase Ia and ongoing Phase Ib studies, and demonstrate the clinical benefit and potential competitive advantages of Coversin.”

About Akari Therapeutics Plc

Akari is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. Akari’s lead drug, Coversin is a second-generation complement inhibitor that acts on complement component-C5, preventing release of C5a and formation of C5b-9 (also known as the membrane attack complex or MAC). C5 inhibition is growing in importance in a range of rare autoimmune diseases related to dysregulation of the complement component of the immune system, including Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and Guillain Barré syndrome (GBS).

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for Coversin may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; our inability to obtain additional capital on acceptable terms, or at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs; and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K filed on March 23, 2016. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Contact: Investor & Media Contact: The Trout Group Tricia Truehart ttruehart@troutgroup.com 646–378–2953 Media Contact: Susan Forman / Laura Radocaj Dian Griesel Int'l. (212) 825-3210

Source:Akari Therapeutics, Plc