Akari Therapeutics Announces New Data Supporting Use of Drug Candidate Votucalis Targeting Difficult to Treat Pain and Itch

Broad-acting antihistamine has potential in number of disease areas with unmet clinical need

NEW YORK and LONDON, March 09, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases, today announced new preclinical data published in Frontiers in Pharmacology demonstrating that Akari’s pipeline candidate votucalis has potential as a treatment for pain and itch associated with conditions such as atopic dermatitis, psoriasis and neuropathic pain.

Votucalis is a broad-acting histamine inhibitor that was discovered through the same research program that yielded Akari’s lead drug, nomacopan, a complement and leukotriene inhibitor currently in Phase III clinical development. Votucalis, by binding to histamine, inhibits all four histamine G-protein coupled receptors (GPCRs): H1, H2, H3 and H4 opening up new treatment options currently not available with marketed antihistamine treatments that target only the H1 or H2 receptors. Activation of these receptors can induce multiple pathophysiological processes, including chronic pain, itch and inflammation.

Clive Richardson, CEO of Akari Therapeutics, said: “The unique inhibition of the histamine pathway by votucalis affords Akari the potential to expand our existing dermatology franchise as well as exploring votucalis as a treatment for pain where current treatments such as opioids can be ineffective and can have serious side-effects including addiction. We look forward to continuing our collaboration with Durham and Newcastle Universities to move this program forward.”

The data published today were from two preclinical models of itch and pain in mice.

In pain, votucalis produced a potent and complete anti-sensation effect in a mechanical hypersensitivity model. Local administration of votucalis was achieved at significantly lower doses and produced a longer duration of effect than systemic administration. The research also showed that Votucalis does not enter the brain, which means it is unlikely to cause central nervous system (CNS) mediated side effects typical of opioids.

In itch, votucalis provided inhibition of histaminergic itch of around 62%, with the potential for greater reduction with higher dosing. Peripheral H1 and H2 or central H4 antagonism inhibited histaminergic itch of around 64%, 53% and 27 %, respectively. When peripheral antagonists were combined with votucalis, itch was reduced between 80% and 90%. As in pain, the local route of administration was most effective, opening up the potential for topical administration. Prior work in human skin cadaver experiments indicate that votucalis may be suitable for topical delivery.

A further program of work is ongoing with our collaborators Dr. Paul Chazot, Durham University, and Dr Ilona Obara, Newcastle University, focused on the effect of locally administered nomacopan on inflammation and pain. This should allow Akari to begin planning for a clinical program by the end of the year benefiting from an already advanced GMP manufacturing program.

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, nomacopan, is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan is currently being clinically evaluated in four areas: bullous pemphigoid (BP), thrombotic microangiopathy (TMA), as well as programs in the eye and lung.

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 Nomacopan 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 Nomacopan and any other product candidates and unexpected costs that may result therefrom; difficulties enrolling patients in our clinical trials; our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us; failure to realize any value of Nomacopan 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 U.S. Food and Drug Administration (FDA) and European Medicines Agency (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 Nomacopan may not be as large as expected; risks associated with the impact of the COVID-19 pandemic; 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 Securities and Exchange Commission (SEC), including our most recently filed Annual Report on Form 20-F filed with the SEC. 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.

For more information

Investor Contact:

Peter Vozzo

ICR Westwicke

(443) 213-0505

peter.vozzo@westwicke.com

Media Contact:

Sukaina Virji/ Maya Bennison

Consilium Strategic Communications

Akari@consilium-comms.com