Akari Therapeutics Plc Stock Price, News & Analysis

Akari Therapeutics (Nasdaq: AKTX) has initiated a multicenter Phase III study for nomacopan, targeting moderate and severe bullous pemphigoid (BP). This treatment aims to replace long-term steroid usage, which poses significant health risks to elderly patients. The FDA has granted Fast Track and orphan drug designations for nomacopan, facilitating quicker development and review processes. Success in treating BP could extend nomacopan's application to other severe skin conditions. BP affects around 120,000 patients in the U.S. and EU, predominantly in moderate and severe stages.

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.

Akari Therapeutics has opened Investigational New Drug Applications with the FDA for Phase III studies of nomacopan, targeting bullous pemphigoid and pediatric HSCT-TMA. New data suggests nomacopan's potential in treating dry age-related macular degeneration and COVID-19 pneumonia. Positive long-term data shows that nomacopan is well-tolerated in paroxysmal nocturnal hemoglobinuria patients, reducing transfusion dependence by 79%. Financial results for 2020 show cash increased to $14.1 million, though a net loss of $17.1 million was reported.

Akari Therapeutics has opened an investigational new drug application (IND) with the FDA for nomacopan, targeting moderate to severe bullous pemphigoid (BP). Clinical recruitment is set to commence by mid-2021, pending COVID-19 restrictions. Nomacopan has received orphan drug designation from both the FDA and EMA. The Phase III trial aims to validate nomacopan’s unique therapeutic advantages, based on successful Phase II studies, with a focus on patient remission.

Akari Therapeutics announces a cooperative research and development agreement with the U.S. Army Institute of Surgical Research (USAISR) to study nomacopan for trauma treatment. This investigational drug targets inflammation in trauma cases, showing promise in conditions like traumatic brain injury and myocardial infarction. The study aims to evaluate nomacopan's efficacy in preclinical trauma models. With trauma being a leading cause of death under 45 years, Akari aims to address the lack of approved therapies, potentially benefiting both military and civilian patients.

Akari Therapeutics (Nasdaq: AKTX) announced new findings published in CELLS revealing the role of LTB4 in promoting VEGF-related retinal inflammation, contributing to wet AMD. In preclinical models, PAS-nomacopan, a long-acting version of their drug, significantly reduced neo-vascularization equivalent to the FDA-approved Eyelea^®. The study demonstrated over 50% reduction in VEGF levels in uveitis models, highlighting PAS-nomacopan's dual mechanism of action that inhibits both LTB4 and complement C5, potentially offering new treatment avenues for eye diseases.

Akari Therapeutics (Nasdaq: AKTX) is advancing its therapeutic candidate, votucalis, which inhibits histamine and targets chronic neuropathic pain and dermatological conditions. New pre-clinical data demonstrate votucalis's effectiveness in blocking neuropathic pain symptoms and treating atopic dermatitis. Unlike conventional opioids, votucalis acts peripherally, minimizing CNS-related side effects. Local administration showed superior results compared to systemic treatment. Akari aims to initiate Phase II trials in 2022, positioning votucalis as a potential innovative solution in pain management and inflammatory diseases.

Akari Therapeutics, Plc (Nasdaq: AKTX) announced CEO Clive Richardson will participate in two upcoming virtual investor conferences. The H.C. Wainwright BioConnect Conference will feature an on-demand presentation starting January 11, 2021. The ICR Conference 2021 is scheduled for January 14, 2021, at 10:00 a.m. ET. Investors can arrange virtual meetings during the ICR Conference. Akari develops therapies targeting orphan autoimmune and inflammatory diseases, with its lead drug candidate, nomacopan, inhibiting complement C5 and leukotriene B4 systems.

Akari Therapeutics, Plc (AKTX) announced progress in its clinical programs, including a pivotal Phase III trial for bullous pemphigoid (BP) expected to start in H1 2021, and enrollment for pediatric HSCT-TMA beginning in Europe. The company reported third-quarter financial results showing a net income of $1.4 million, reversing a loss from the previous year, largely due to increased other income and R&D tax credits. However, ongoing COVID-19 challenges may delay clinical trials and operations, impacting timelines. Cash as of September 30, 2020, stood at approximately $12.3 million.