Akari Therapeutics Announces Poster Presentation of Phase II Bullous Pemphigoid Disease and Phase III Trial Design at American Academy of Dermatology Association Virtual Meeting Experience
Akari Therapeutics, Plc (Nasdaq: AKTX) announced the presentation of a poster at the American Academy of Dermatology Association (AAD) Virtual Meeting Experience from April 23-25, 2021. The poster, titled “Disease Remission During a Short-term Treatment Phase II Study of Nomacopan in Mild-to-moderate Bullous Pemphigoid,” highlights results from a Phase II study focusing on disease control metrics. The upcoming Phase III trial for nomacopan will open for recruitment mid-2021, following FDA and EMA clearance, as Akari continues its focus on treating orphan diseases through novel therapeutics.
- Presentation of promising Phase II study results at a significant dermatology meeting.
- Anticipated opening of Phase III trial for nomacopan in mid-2021 after receiving regulatory approval from FDA and EMA.
- None.
NEW YORK and LONDON, April 22, 2021 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and leukotriene systems are implicated, announced today that it will present a poster at the American Academy of Dermatology Association (AAD) Virtual Meeting Experience (VMX) taking place April 23-25, 2021.
The poster will be made available on AAD’s VMX platform beginning April 23, 2021, and the Akari corporate website at http://investor.akaritx.com/news-and-events/presentations following the meeting.
Poster Details
Title: “Disease Remission During a Short-term Treatment Phase II Study of Nomacopan in Mild-to-moderate Bullous Pemphigoid”
Category: Immunodermatology & Blistering Disorders
Presentation date: April 23, 2021
Presentation Time: Beginning 9:00 a.m. CT
The poster describes results from the completed Phase II study (NCT04035733) of nomacopan for treatment of bullous pemphigoid (BP), with a specific focus on the disease control recorded at each clinical visit during the short-term (6-week) treatment period. Disease control is an important variable, as it will be used to decide when to taper the adjunct oral corticosteroid dose in the upcoming 24-week nomacopan treatment Phase III BP randomized controlled trial whose design is also presented in the poster.
The Phase III trial in moderate to severe BP patients was refined following successful end of Phase II meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The trial is anticipated to open for recruitment in the U.S. and Europe mid-2021. Earlier this month, Akari announced that the FDA investigational new drug application (IND) is now open in the U.S. for the BP Phase III trial.
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 binds to and 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. 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; 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 departure of our former Chief Executive Officers and other executive officers; 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.
For more information
Investor Contact:
Peter Vozzo
Westwicke/ICR
(443) 213-0505
peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Nicholas Brown / Lizzie Seeley
Consilium Strategic Communications
+44 (0)20 3709 5700
Akari@consilium-comms.com
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