UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
November 2018
Commission file number: 001-36288
Akari Therapeutics, Plc
(Translation of registrant's name into English)
75/76 Wimpole Street
London W1G 9RT
United Kingdom
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____
CONTENTS
On November 15, 2018, Akari Therapeutics, Plc, (the “Company”) issued a press release entitled “Akari Announces Coversin Data to be Presented at 2018 Complement-Based Drug Development Summit.”
A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The first three paragraphs and “Forward Looking Statements” of the press release attached to this Form 6-K are hereby incorporated by reference into all effective registration statements filed by the Company under the Securities Act of 1933.
| Exhibit No. | |
| 99.1 | Press Release dated November 15, 2018. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Akari Therapeutics, Plc | |||
| (Registrant) | |||
| By: | /s/ Clive Richardson | ||
| Name: | Clive Richardson | ||
| Interim Chief Executive Officer and Chief Operating Officer | |||
Date: November 15, 2018
Exhibit 99.1
Akari Announces Coversin Data to be Presented at 2018 Complement-Based Drug Development Summit
| ‒ | Highlights potential role of both complement and leukotriene pathways in a therapeutic mouse model of rheumatoid arthritis (RA) |
NEW YORK and LONDON, November 15, 2018 - Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and or leukotriene systems are implicated, today announced that PASylated Coversin data will be presented at the 2nd Annual 2018 Complement-Based Drug Development Summit in Boston, Mass. during an oral presentation by Andrew Luster, M.D., Ph.D., Chief, Division of Rheumatology, Allergy and Immunology & Director, Center for Immunology and Inflammatory Diseases Massachusetts General Hospital. The presentation will take place on November 15, 2018, at 9:10 a.m. EST.
In Dr. Luster’s RA model, PASylated Coversin, which is a longer half-life version of the parent molecule Coversin, and which similarly is able to inhibit both C5 and LTB4, was more effective than LTB4 inhibition alone, completely eliminating rheumatic symptoms within six days of initiating treatment.
These data point to an increasing potential set of clinical targets available to treatment with Coversin’s combined C5 and LTB4 functionality. Akari currently has two clinical programs open in bullous pemphigoid (BP) and atopic keratoconjunctivitis (AKC) where both C5 and LTB4 are believed to be implicated. The Company expects initial data readouts from both trials in the first quarter of 2019.
Dr. Luster stated, “The effect of Coversin (PASYlated) used therapeutically in our mouse model of RA was impressive with apparent total disease reversal. This highlights that the novel strategy offered by Coversin of simultaneously blocking both C5 and LTB4 may make it an effective anti-inflammatory treatment and offers the potential to provide an alternative therapy for RA patients who are unresponsive to current marketed therapies.”
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's lead drug candidate, Coversin, is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Coversin is currently being clinically evaluated in four indications: bullous pemphigoid (BP), atopic keratoconjunctivitis (AKC), atypical hemolytic uremic syndrome (aHUS), and paroxysmal nocturnal hemoglobinuria (PNH). Akari believes that the dual action of Coversin on both C5 and LTB4 may be beneficial in AKC, BP, and aHUS. Akari is also developing other tick derived proteins, including longer acting versions.
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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: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; 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; difficulties enrolling patients in our clinical trials; 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; risks associated with the departure of our former Chief Executive Officers and other executive officers; risks related to material weaknesses in our internal controls over financial reporting and risks relating to the ineffectiveness of our disclosure controls and procedures; risks associated with the putative shareholder class action and SEC investigation; 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; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC on July 18, 2018. 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.
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For more information
Investor Contact:
Peter Vozzo
Westwicke Partners
(443) 213-0505
peter.vozzo@westwicke.com
Media Contact:
Mary-Jane Elliott / Sukaina Virji / Nicholas Brown
Consilium Strategic Communications
+44 (0)20 3709 5700
Akari@consilium-comms.com
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