Clive Richardson, executive director of Akari Therapeutics, said: “There is still an urgent need for a more effective remedy for patients hospitalized with coVID-19 pneumonia.I am very pleased that nomacopan has been chosen through the AGILE clinical programme in the UK.You can also point out that lately we are treating patients in Brazil and the United States as a component of initial trial studies, with the purpose of moving on to randomized clinical studies in the fourth quarter of 2020.We who nomacopan have the prospect of inhibiting the key and prothromotic pro-inflammatory pathways that cause this disease and therefore decrease morbidity and mortality in this organization of patients with COVID-19.
Scientific justification for the use of nomacopan in pneumonia in COVID-19
Inhibition of the double supplement of Nomacopan (C5) and leukotriene (LTB4) blocks key inflammatory pathways leading to pneumonia in COVID-19.
Neutrophil buildup in the lungs is another key feature of COVID-19 pneumonia, resulting in “cytokine typhoon syndrome” and related epithelial lesions in the lungs and other organs. Leukotriene (LTB4) is one of the known maximum chemo-attractive agents of neutrophils and other chemo-attractive neutrophils seem to depend on the synthesis of LTB4 for neutrophil recruitment from distal sites. Leukotriene inhibitors are approved for the treatment of asthma and are lately being tested in COVID-193 pneumonia due to their ability to block several cytokines. Cytokines and chemokies inhibited through nomacopan4 come with GM-CSF, IL1 alfa, IL1beta, IL2, IL-6, IL17, TNF, RANTES, MCP1, MIP1alpha and MIP1beta, all of which have been reported as the best in patients with COVID-195 pneumonia.
The potential additive benefits of C5 and LTB4 nomacopan inhibition have already been demonstrated in preclinical styles of virus-induced acute respiratory misery syndrome (SDRA) with reduced inflammation and mortality.6 In addition, the combined inhibition of C5 and LTB4 demonstrated through nomacopan is impressive for inhibition through C5 or LTB4 only in a mouse style of acute lung inflammation , highlighting the additive effect of inhibition of these two innate immune pathways7.
Akari believes that this inhibition of multiple inflammatory pathways distinguishes the nomacopan from other prospective treatments aimed at an unmarried mechanism of action. In addition to the immediate onset of nomacopan action, immediate normalization of the supplement and LTB4 grades at the end of the remedy has the possibility of avoiding the long-term immunosuppression hazards typical of monoclonal antibodies.
Step-by-step clinical progression plan with nomacopan for the treatment of COVID-19 pneumonia
An observational study relating to biomarkers that may identify COVID-19 patients who are particularly suitable for nomacopan treatment is ongoing in the U.K. Data has been collected on approximately 50 patients with COVID-19 pneumonia and analysis of the samples is in process with data expected early in the fourth quarter of 2020. The second part of the program, a longitudinal study taking repeat samples from COVID-19 patients with worsening disease is ongoing.
The initial remedy for COPs in coVID-19 pneumonia patients through Expanded Access Programs (AEPs) is underway in the United States. In Brazil, recruitment for a similar COP review is comprehensive and knowledge will be reviewed for protection through the Data Monitoring and Security Board (DSMB). If the DSMB concludes that the drug is safe, the program in Brazil will move to a randomized examination in the fourth quarter of 2020.
These COVID-19 programs build on the existing Akari clinical experience in the use of nomacopan, underpinned by 35 cumulative patient-years of nomacopan safety data with no reported drug related SAEs, and clinical response across a range of inflammatory conditions in Phase II and Phase III development.
Planned randomized clinical studies
In the United States, Akari participates in a researcher-led multicenter randomized exam assignment, which is lately subject to approval by the U.S. Food and Drug Administration (FDA) for a similar IND. In Brazil, the POP test is expected to become a randomized trial, pending success of the DSMB test.
In the UK, the nomacopan was decided through the AGILE platform as a new prospective remedy for patients with pneumonia in COVID-19. AGILE is a healing progression platform committed to the help of the Wellcome Trust and UNITAID to identify, help and expand promising remedies for COVID-19. The AGILE programme is sponsored through the Royal Liverpool Hospital, United Kingdom. With the help of AGILE, Akari is also making plans to expand the COVID-19 nomacopan clinical program to several African countries, with prospective patient recruitment from the fourth quarter of 2020.
Subject to further regulatory comment, the trial protocols for planned randomized clinical trials would require patients to be randomized 2: 1 plus popular care nomacopan (SoC) or SoC alone, with an initial target of approximately 60 patients in each of the individual exam parameters. Patients would receive supportive oxygen (not intubated) and would be recruited after admission to the hospital. The number one endpoint is oxygen popularization time, while the secondary endpoint will come with the need for intubation and mortality. Patients will receive a daily subcutaneous dose of nomacopan for up to 14 days, with follow-up and final touch of the exam after two months. The SoC trial arm incorporates the newer treatments, adding dexamethasone and remdesivir, either of which has a different mode of action than nomacopan, and as such, nomacopan has the potential to increase the efficacy of one or either of those treatments. . When examining the effectiveness of nomacopan, Akari hopes to take into account all the knowledge from those studies with the same parameters.
Professor Tim Higenbottam, president of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom, said: “It is increasingly transparent that the complexity of coVID-19 co-pneumonia treatment is similar to its multi-pro-inflammatory pathways For effective treatment, we want a broad-acting anti-inflammatory and the fact that it has been shown in clinical trials that nomacopan inhibits the pathways underlying this devastating serious disease creates a promising platform for your existing clinical research.
Akari will host a convention and a webcast today, August 31, 2020, at 8:30 am EDT (1:30 BST).The convention will be called at (844) 461-9933 (toll-free) or (636).) 812-6633 (international) convention number 2469894 The webcast will be conducted live through the Investor Relations segment of Akari’s website, in https://investor.akaritx.com/news-and-events/events.
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.
Cautionary Note Regarding Forward-Looking StatementsCertain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. You should not place undue reliance upon the Company’s forward looking statements. Except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this press release. 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 U.S. 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 successfully develop nomacopan as a treatment for COVID-19 related pneumonia and to successfully commercialize any product in that indication; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general and risks specific to the development of potential treatments for COVID-19 related illnesses; 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 U.S.; 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 impact of the outbreak of coronavirus; risks associated with the SEC investigation; 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 US 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.
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