- Safety and efficacy data from Phase II clinical trial of nomacopan in adults with mild to moderate BP
- The Phase II data was the basis for the agreement of the FDA and the EMA that Akari may proceed to a Phase III randomised placebo-controlled study using nomacopan for treatment of BP
- Phase III study in both the U.S. and Europe expected to begin in H1 2021
- Nomacopan has been granted orphan drug designation for treatment of BP in the U.S. and Europe
NEW YORK and LONDON, October 27 2020 – Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, today announces that it will be presenting a poster during the 29th European Academy of Dermatology and Venereology (EADV) Congress being held virtually October 28 – November 1, 2020. The presentation will be posted onto Akari’s website.
The poster presentation will describe the safety and efficacy data from Akari’s Phase II clinical trial of nomacopan in adult patients with mild to moderate bullous pemphigoid.
Details of the presentation are as follows:
- Title: A Phase II Clinical Trial of Safety and Efficacy of Nomacopan (rVA576) in Adult Mild-to-moderate Bullous Pemphigoid Patients
- Date/Time: October 29, 2020 at 12:00 CET (7:00 a.m. EDT)
- Location: EADV Virtual Meeting. Registration is required to participate: https://eadvvirtualcongress.org/registration/
About Bullous Pemphigoid (BP)
BP is a severe orphan autoimmune inflammatory blistering skin disease with no approved treatments in the U.S. and Europe. This disease of the elderly is primarily treated with steroids and immunosuppressants for six months plus which bring with them deleterious side effects and an approximately three-fold increase in mortality in the BP treated population. The prevalence of BP is over 100,000 patients in US and Europe.
In BP patients there is evidence that both terminal complement activation (via complement component C5) and the lipid mediator leukotriene B4 (LTB4) have a central role in driving the disease. Ex vivo data in BP patients, published in the August 2019 edition of JCI Insight, showed a pronounced accumulation of LTB4 and C5 and its activation products in the inflamed skin of BP patients. This underlies the rationale for treatment with nomacopan which is a unique bifunctional inhibitor of both C5 and LTB4 and a range of downstream cytokines. In addition to BP, the Company believes this unique mode of action underpins the activity of nomacopan across the Company’s other target conditions – TMA-HSCT, COVID pneumonia and ophthalmology as well as other emerging clinical indications.
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 (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity.
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. You should not place undue reliance upon the Company’s forward looking statements. Except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this press release. 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 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 nomacopan may not be as large as expected; risks associated with the impact of the outbreak of coronavirus; risks associated with the 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. 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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Sukaina Virji / Lizzie Seeley
Consilium Strategic Communications
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