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Akari Therapeutics plc develops oncology antibody-drug conjugates built around RNA splicing modulator payloads. News about AKTX centers on its ADC platform, the PH1 payload technology, and lead program AKTX-101, a TROP2-targeted ADC studied in solid tumor models including bladder, lung and breast cancer. Updates also cover intellectual-property protection for the company’s payload chemistry and therapeutic applications.
Recurring company developments include preclinical data releases, oncology conference abstracts, strategic development collaborations, capital-structure disclosures, governance matters, and American Depositary Share program updates. As an ADR issuer, Akari’s news may also address ordinary-share and ADS mechanics tied to Nasdaq listing requirements and shareholder approvals.
Akari Therapeutics (NASDAQ: AKTX) announced positive pre-clinical results for PAS-nomacopan aimed at treating geographic atrophy (GA) in dry age-related macular degeneration (dAMD), a condition with no current treatments. The studies highlighted tolerability and the potential for extended dosing intervals of over three months, which could ease patient burden. New pharmacokinetic measurements indicate improved half-life for the drug in the eye. CEO Rachelle Jacques emphasized the supportive data for advancing toward regulatory applications necessary for clinical trials by year-end.
Akari Therapeutics (NASDAQ: AKTX) recently announced significant progress in its clinical trials and financial results for Q1 2022. The Phase 3 Part A trial of nomacopan for severe pediatric HSCT thrombotic microangiopathy (TMA) has enrolled four out of seven planned patients. Additionally, ten sites have opened for the ARREST-BP Phase 3 trial in bullous pemphigoid (BP), aiming to enroll 48 patients. Financially, cash increased to approximately $16.7 million, with a net loss of $5.2 million. The company continues to advance pre-clinical programs for geographic atrophy in dAMD.
Akari Therapeutics (Nasdaq: AKTX) announced a patient has completed treatment in the Phase III clinical trial of nomacopan for pediatric HSCT-TMA, a serious post-stem cell transplant complication. Nomacopan, a bispecific inhibitor, shows promise as it is currently the only investigational therapy with Orphan Drug and Fast Track designations from the FDA. The trial aims to recruit seven pediatric patients in the U.S., U.K., and Poland. While one patient was discharged after over 60 days of treatment, another unfortunately died from unrelated complications. The mortality rate for severe HSCT-TMA is 80%. The study's primary endpoints focus on red blood cell transfusion independence and urine protein levels.
Akari Therapeutics, Plc (Nasdaq: AKTX) announced the appointment of Melissa Bradford-Klug as Chief Operating Officer, effective July 1, 2022. With over 25 years of experience across biotech and healthcare sectors, she will drive business development strategies and oversee the advancement of nomacopan, Akari's lead asset, targeting conditions like bullous pemphigoid. Bradford-Klug's appointment is expected to strengthen Akari's operational capabilities and accelerate clinical trials, enhancing the company's growth prospects and commitment to addressing unmet medical needs.
Akari Therapeutics (Nasdaq: AKTX) presented findings from its CASCADE and CORONET studies on COVID-19 pneumonia at the ATS 2022 Annual Meeting. The CASCADE study revealed elevated inflammatory biomarkers in COVID-19 pneumonia patients compared to healthy controls. The CORONET study demonstrated that 6 out of 7 hospitalized patients treated with the investigational drug nomacopan survived, showcasing its potential in reducing COVID-19 complications. No adverse effects were reported. The company focuses on therapies for autoimmune and inflammatory diseases, with nomacopan targeting complement activation.
Akari Therapeutics has initiated Phase III studies of nomacopan for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy and bullous pemphigoid, addressing critical unmet needs with no current approved treatments. The company's preclinical program for long-acting PAS-nomacopan shows promise in treating geographic atrophy/dry age-related macular degeneration. Financially, Akari reported a net loss of approximately $17.4 million for 2021, with cash reserves down to $9.4 million. The company increased manufacturing yield of nomacopan significantly, enhancing its development capabilities.
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.