Akari Therapeutics announces new data with Nomacopan from its Surface of the Eye program

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Nomacopan eye drops reduced inflammation more than the two standard treatments, cyclosporine and the steroid dexamethasone in an allergic eye disease model

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Building on early clinical data in atopic keratoconjunctivitis (AKC), Akari is now advancing its eye surface program

NEW YORK and LONDON, October 25, 2021 (GLOBE NEWSWIRE) – Akari Therapeutics, Plc (Nasdaq: AKTX), an advanced stage biopharmaceutical company focused on innovative therapies to treat orphan autoimmune and inflammatory diseases where complement (C5 ) and / or the leukotriene systems (LTB4) are involved, today announces data highlighting the potential of nomacopan on the surface of the eye in Allergie, European Journal of Allergy and Clinical Immunology.

A copy of the article in Allergy, in which some of the data has been published, is available on Akari’s website at www.akaritx.com and at https://onlinelibrary.wiley.com/doi/10.1111/all.15128 .

Professor Virginia Calder, University College of London (UCL), Institute of Ophthalmology and study author, commented: “These new data confirm the clear role of leukotriene LTB4 and complement C5 in inflammatory pathways that cause allergic eye disease and indicate that nomacopan eye drops are a potentially exciting new area of ​​the eye treatment option. Current treatments such as steroids are limited by side effects, varying efficacy, and patient comfort. The role of nomacopan in reducing specific inflammatory mediators that can be detected in tear fluid as biomarkers is a new feature and opens the potential for patient-targeted treatment management. ”

The article in Allergy summarizes a large body of work undertaken with the University College of London and Moorfields Eye Hospital. The underlying work demonstrates a clear dose-response effect for nomacopan. The optimal dose of nomacopan showed a greater reduction in inflammation score than cyclosporin and dexamethasone compared to the control at day 10 (79% [nomacopan], 41% [cyclosporin], and 73% [dexamethasone]) in an experimental model of allergic eye disease.

The improvement in inflammation observed with nomacopan in this model is probably in part a consequence of the increased suppression of pro-inflammatory T helper 2 (Th2), Th9 cells and cytokine IL-9 by nomacopan compared to cyclosporine and dexamethasone. On the surface of eye diseases, Th2 cells are recognized as the main mediators of allergic responses although other inflammatory mediators are often also involved.

This model shares many features with vernal keratoconjunctivitis (VKC), a difficult-to-treat keratinizing eye disease like AKC. Tear fluid and tissue samples from patients with VKC were analyzed and patients with active disease exhibited a similar biomarker profile to that seen in the allergy model with elevated Th cells and IL-9 as well as ‘increased expression of C5a and BLT1 (LTB4) receptors in infiltrating cells.

These data complement Akari’s Phase I / II study in patients with severe AKC where nomacopan was comfortable and well tolerated (Sanchez-Tabernero et al 2021) and where Akari is exploring further work focused on patients. in keratinization and dry eye.

Akari is currently collaborating on a topical mucosal pemphigoid (MMP) program. More than half of patients with MMP have a type of disease that affects the surface of the eye for which there is no approved treatment. MMP shares a similar pathology with bullous pemphigoid where Akari has initiated a phase III study with nomacopan.

Clive Richardson, Chief Executive Officer of Akari, commented: “The new ocular data surface is an important milestone in our program and highlights the potential benefits of nomacopan’s differentiated bispecific mode of action. to the more severe form of these diseases as important clinical targets for nomacopan in the surface of the 6 billion and more ocular market.

About Akari Therapeutics

Akari is a biopharmaceutical company focused on the development of inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, particularly those where the complement (C5) or leukotrienes (LTB4) systems, or both complement and leukotrienes together play a primary role in the progression of the disease. Akari’s lead drug candidate, Nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits the activity of leukotriene B4 (LTB4). Nomacopan is currently under clinical evaluation in four areas: bullous pemphigoid (BP), thrombotic microangiopathy (MAT), as well as programs in the eye and lung.

Caution Regarding Forward-Looking Statements

Certain statements contained in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, concerning, among other things, the statements relating to the offering of securities described herein, the expected gross proceeds and the closing of the offer. These forward-looking statements reflect our current views on our plans, intentions, expectations, strategies and prospects, which are based on information currently available to us and on the assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected or suggested by these forward-looking statements are reasonable, we cannot guarantee that the plans, intentions, expectations or strategies will be achieved or realized. In addition, actual results may differ materially from those described in forward-looking statements and will be affected by various risks and factors beyond our control. Such risks and uncertainties to our company include, but are not limited to: the need for additional capital to finance our operations; our ability to continue to operate; uncertainties in cash flow and inability to meet working capital requirements; an inability or delay in obtaining the required regulatory approvals for Nomacopan and any other product candidate, which may result in unforeseen expenses; our ability to achieve orphan drug designation in other indications; the risks inherent in drug development in general; uncertainties about obtaining positive clinical results for Nomacopan and any other product candidates and the unexpected costs that could result; difficulties in recruiting patients in our clinical trials; our ability to enter into collaborative, licensing and other commercial relationships and on terms that are commercially reasonable to us; failure to realize the value of Nomacopan and any other product candidate developed and under development in light of the inherent risks and difficulties inherent in successfully bringing the product candidates to market; inability to develop new product candidates and support existing product candidates; approval by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) and other similar foreign regulatory authority of other competitive or superior products placed on the market; risks resulting from unforeseen side effects; the risk that the Nomacopan market will not be as large as expected; the risks associated with the impact of the COVID-19 pandemic; the inability to obtain, maintain and enforce patents and other intellectual property rights or the unforeseen costs associated with such application or litigation; failure to obtain and maintain commercial manufacturing agreements with third party manufacturers or to establish commercial scale manufacturing capabilities; the inability to source timely for an adequate supply of our active pharmaceutical ingredients from third party manufacturers on which the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the Securities and Exchange Commission (SEC), including our most recent annual report filed on Form 20-F filed with the SEC. Unless otherwise indicated, these forward-looking statements speak only as of the date of this press release and we assume 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 significant reliance on any forward-looking statements contained in this press release.

For more information

Investor contact:

Pierre Vozzo

Westwicke

+1 (443) 213-0505

[email protected]

Media contact:

Sukaina Virji / / Ashley Tapp

Strategic communication of the Consilium

+44 (0) 20 3709 5700

[email protected]

Disclaimer

Akari Therapeutics plc published this content on 25 October 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on 25 October 2021 20:55:13 UTC.

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