NEW YORK and LONDON, Dec. 07, 2015 (GLOBE NEWSWIRE) -- Akari Therapeutics (NASDAQ: AKTX ), an emerging growth, development-stage biopharmaceutical company, provided an update from its 28 day non-human primate (NHP) safety study at the International PNH Interest Group 10th Annual Scientific Meeting held on December 4 th , 2015 in Orlando, Florida. The study tested Coversin daily subcutaneous injection for 28 days at a low and high dose versus placebo in 24 non-human primates and demonstrated no safety issues, adverse events or injection site reactions. 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).
“In this study, we demonstrated steady state complete complement inhibition in non-human primates given a single daily subcutaneous dose of Coversin. The steady state was achieved even though in non-human primates, Coversin had a more rapid onset and offset of action compared to that seen in our Phase Ia healthy volunteer data,” said Miles Nunn, Chief Scientific Officer of Akari Therapeutics. “After a single injection in non-human primates, complement activity in the high dose group returned to 25% of baseline by 24 hours, compared to about 5% of baseline by 24 hours in the 0.57mg/kg cohort of our Phase Ia healthy volunteer study.”
“The non-human primate safety and complement inhibition data strengthen our belief that daily subcutaneous administration of Coversin in humans at an appropriate dose, to be determined in our upcoming Phase 1b study, should provide complete and highly stable chronic complement inhibition,” said Gur Roshwalb, Chief Executive Officer of Akari Therapeutics. “We believe that Coversin has the potential to be the best-in-class second generation complement C5 inhibitor in development.”
Full data from this safety study will be presented at a future scientific forum.
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 product, 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 Quarterly Report on Form 10-Q filed on November 23, 2015. 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: Akari Therapeutics Plc Gur Roshwalb, MD, CEO 646-350-0702 info@AkariTx.com
