Akari Therapeutics to Present Its Phase III Plans for Nomacopan in Patients with Bullous Pemphigoid at the 2021 International Pemphigus & Pemphigoid Foundation (IPPF) Scientific Symposium
On September 10, 2021, Akari Therapeutics (Nasdaq: AKTX) announced that Dr. Miles Nunn and Dr. Sanjeev Khindri will present a poster on the Phase III study design of nomacopan for treating moderate to severe bullous pemphigoid (BP) at the 2021 IPPF Scientific Symposium. The trial aims to evaluate nomacopan's safety and its capacity to control BP symptoms while reducing reliance on systemic steroids. The presentation is scheduled for September 20, 2021. Akari focuses on innovative therapeutics for orphan autoimmune diseases and has identified significant potential for nomacopan as a targeted therapy.
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NEW YORK and LONDON, Sept. 10, 2021 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced that Miles Nunn, Ph.D., Chief Scientific Officer of Akari Therapeutics, and Sanjeev Khindri, M.D., Medical Director of Akari Therapeutics, will present a poster outlining the design of the Company’s Phase III planned pivotal study of nomacopan in patients with moderate to severe bullous pemphigoid (BP) at the 2021 International Pemphigus & Pemphigoid Foundation (IPPF) Scientific Symposium.
The IPPF’s main focus is to improve the quality of life for all those affected by pemphigus and pemphigoid through early diagnosis and support alongside an active patient outreach program. The 2021 IPPF Scientific Symposium will bring together clinical and scientific experts in the field of autoimmune bullous disorders.
“There remains a critical unmet medical need for new therapies for BP patients, with current treatments limited by significant side effects and relapses,” said Dr. Khindri. “With clear evidence for the role of both complement and LTB4 in BP, nomacopan as a first-in-class biological dual inhibitor offers a potential novel targeted therapy for BP.”
The aim of the ARREST-BP Phase III trial is to assess the safety of nomacopan in BP patients, and to test nomacopan’s ability to rapidly control the symptoms of BP and reduce exposure to systemic steroids to potentially decrease steroid related morbidity and mortality.
Details of Akari’s presentation are as follows:
| Event: | The 2021 IPPF Scientific Symposium | |
| Poster Date/Time: | September 20, 2021; 1:00 p.m. – 3:00 p.m. EDT (6:00 p.m.– 8:00 p.m. BST) | |
| Poster Title: | ARREST-BP: A Randomised Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Nomacopan Therapy in Bullous Pemphigoid Patients Receiving Adjunct Oral Corticosteroid |
To access the abstract discussion session, register directly for the IPPF conference here: https://web.cvent.com/event/81fd8132-20ce-452b-afdc-e34ba6fefbd3/summary
The poster will be made available in the Presentations section of the Akari corporate website at http://investor.akaritx.com/news-and-events/presentations following its presentation.
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. 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, regarding, among other things, statements related to the offering of securities described herein, the expected gross proceeds, and the expected closing of the offering. 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
Westwicke/ICR
(443) 213-0505
peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Ashley Tapp / Maya Bennison
Consilium Strategic Communications
+44 (0)20 3709 5700
Akari@consilium-comms.com
FAQ
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