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About Akari Therapeutics Plc
Akari Therapeutics Plc (Nasdaq: AKTX) is a clinical-stage biopharmaceutical company dedicated to advancing innovative therapies for the treatment of rare autoimmune and inflammatory diseases. Akari’s core focus lies in addressing critical unmet medical needs by targeting the complement component 5 (C5) and leukotriene B4 (LTB4) pathways, which are implicated in a range of severe and often life-threatening conditions.
Innovative Drug Development Pipeline
Akari’s lead asset, nomacopan, is a bispecific recombinant inhibitor that simultaneously targets C5 activation and LTB4 activity. This dual mechanism of action positions nomacopan as a potentially transformative therapy for diseases with complex inflammatory and immune-mediated components. Currently, nomacopan is undergoing a Phase 3 clinical trial for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA), a rare and severe complication of stem cell transplantation with no approved treatments. The company has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the U.S. FDA, underscoring the significance of this program.
Additionally, Akari is advancing the development of a long-acting version of nomacopan, known as PAS-nomacopan, for the treatment of geographic atrophy (GA), a progressive and sight-threatening condition affecting millions worldwide. This program aims to improve patient outcomes by offering a longer dosing interval and reducing risks associated with existing therapies.
Strategic Expansion and Market Focus
In a strategic move to broaden its pipeline, Akari has announced a merger with Peak Bio Inc., combining Akari’s expertise in autoimmune and inflammatory diseases with Peak Bio’s proprietary antibody-drug conjugate (ADC) platform. This merger is expected to enhance Akari’s capabilities in addressing significant unmet medical needs in oncology and inflammation, further diversifying its portfolio.
Akari operates within the competitive biotech landscape, leveraging its proprietary technologies and focus on orphan diseases to differentiate itself. By targeting niche markets with high barriers to entry and significant clinical needs, Akari is well-positioned to create value for patients and stakeholders alike.
Commitment to Innovation and Patient-Centric Solutions
Akari’s mission is rooted in scientific innovation and patient-centricity. The company’s approach combines cutting-edge research with a deep understanding of disease biology to develop therapies that address the root causes of complex conditions. Akari’s dedication to advancing its pipeline, coupled with strategic collaborations and regulatory achievements, underscores its commitment to transforming the treatment landscape for rare diseases.
Akari Therapeutics (Nasdaq: AKTX) announced the presentation of two posters at the ATS 2022 Annual Meeting, highlighting findings from the CORONET and CASCADE studies related to COVID-19 pneumonia. The CORONET study assessed nomacopan's compassionate use in hospitalized patients, while the CASCADE study focused on biomarker correlations for risk stratification. Presentations are scheduled for May 17, 2022, at the Moscone Center in San Francisco. Akari aims to enhance understanding of inflammation's role in COVID-19, contributing valuable insights to the medical community.
Akari Therapeutics (Nasdaq: AKTX) announced positive Phase II results for nomacopan in treating bullous pemphigoid (BP), a severe autoimmune skin disease. In the study, nine patients received nomacopan; 77.8% responded, with three showing over 80% reduction in disease activity by day 42. Notably, no severe treatment-related adverse events were reported, underscoring nomacopan's safety. This research, published in JAMA Dermatology, supports further development of nomacopan, which could address the unmet need for effective therapies in BP.
Akari Therapeutics (Nasdaq: AKTX) presented promising preclinical results for PASylated-nomacopan at the ARVO 2022 Annual Meeting, focusing on its efficacy in treating geographic atrophy (GA) and choroidal neovascularization (CNV). The findings indicated that PAS-nomacopan significantly reduced CNV in animal models, with a potential dosing interval of three months, thereby addressing patient burden associated with frequent injections. Additionally, nomacopan showed effectiveness in reducing inflammation linked to ocular diseases compared to traditional treatments.
Akari Therapeutics (Nasdaq: AKTX) announced presentations at the ARVO 2022 Annual Meeting focusing on innovative treatments for age-related macular degeneration (AMD) and allergic conjunctival disease. Professor Virginia Calder will present findings on topical nomacopan, a dual inhibitor, while Dr. Wynne Weston-Davies will discuss the long-acting PAS-nomacopan for retinal diseases. Both presentations highlight the unmet need for effective therapies targeting complement and leukotriene pathways in ocular conditions. The event will take place in Denver, CO, from May 1-2, 2022.
Akari Therapeutics (Nasdaq: AKTX) announced new preclinical data for votucalis, a novel broad-acting antihistamine, which shows promise in treating pain and itch linked to conditions like atopic dermatitis and psoriasis. The data, published in Frontiers in Pharmacology, highlight votucalis's ability to inhibit all four histamine GPCRs, offering new treatment avenues not available with current antihistamines. The research indicates votucalis achieves effective local administration at lower doses, potentially reducing CNS-related side effects typical of opioids.
Akari Therapeutics has secured approximately $9.0 million through definitive agreements with institutional and accredited investors, including Chairman Dr. Ray Prudo. The company will issue roughly 7,500,000 American Depository Shares (ADSs) at $1.20 per ADS, accompanied by warrants for additional shares. The offering is expected to close around March 10, 2022, pending customary conditions. This offering is registered under an effective shelf registration statement with the SEC, aiming to bolster Akari's financial position for development of its drug candidate, Nomacopan.
Akari Therapeutics has appointed Rachelle Jacques as President and CEO, effective end of March 2022. Jacques brings extensive experience in biotechnology, particularly in complement (C5) therapies, having previously served as CEO at Enzyvant Therapeutics and held significant roles at Alexion Pharmaceuticals. She is set to enhance the company's Phase 3 pipeline and drive commercialization efforts for nomacopan, a drug targeting rare diseases. Outgoing CEO Clive Richardson will support this transition.
Akari Therapeutics (Nasdaq: AKTX) announced promising results for its complement and leukotriene inhibitor, nomacopan, which improved survival rates in a preclinical trauma model from 30% to 80%. Funded by the U.S. Army's DoD, the findings suggest nomacopan's potential as a treatment for traumatic hemorrhage, addressing both military and civilian needs. The company plans further studies, including a collaboration for a UK observational study on traumatic brain injury. Nomacopan targets critical inflammatory pathways, making it viable for early intervention in severe trauma cases.
Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company, announced that CEO Clive Richardson will present at the BIO CEO & Investor Conference on February 15, 2022, at 2:30 p.m. ET in New York. The presentation will focus on Akari's innovative therapies targeting orphan autoimmune diseases and will be available live and on-demand for registered participants. The Company is developing Nomacopan, a C5 complement inhibitor, for conditions like bullous pemphigoid and thrombotic microangiopathy. Investors are encouraged to arrange meetings with management during the conference.
Akari Therapeutics (Nasdaq: AKTX) announced the development of an inhaled delivery system for its drug nomacopan, targeting orphan autoimmune and inflammatory diseases. Collaborating with Inhalation Sciences AB, Akari aims to enhance dosing and pharmacokinetics for both dry powder and nebulized forms. CEO Clive Richardson emphasized the potential of nomacopan in treating exacerbations in lung diseases like COPD and severe asthma by targeting complement C5 and leukotriene pathways. Observational studies show elevated levels of C5 and LTB4 in exacerbating conditions, supporting nomacopan's therapeutic potential.
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