Akari Therapeutics Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced further development of a program for the inhaled delivery of nomacopan to the lung, working with Inhalation Sciences AB to refine dosing and pharmacokinetics of nomacopan for both dry powder and nebulized delivery.
Clive Richardson, Chief Executive Officer of Akari Therapeutics, said, “Accumulating data with nomacopan indicate that the innate immune response driven by complement and leukotriene pathways could be critical in determining the severity of the inflammatory response across a range of diseases including in the lung. Gaining control of the dysregulation in innate responses by inhibiting C5 and LTB4 with an inhaled form of nomacopan could provide relief from often life-threatening exacerbations in lung illnesses such as COPD and severe asthma. We are therefore delighted to be working with Inhalation Biosciences AB to further develop an inhaled drug delivery system for nomacopan.”
Data from Akari-sponsored observational studies in exacerbating chronic obstructive pulmonary disease (COPD) (n=24) and COVID-pneumonia (n= 72) indicated complement C5 and LTB4 levels were elevated and the severity of exacerbations in COPD patients was associated with the initial levels of C5. This points to the potential for nomacopan, a potent inhibitor of both C5 and LTB4, as a focused treatment for disease exacerbations across multiple severe lung disorders, including severe asthma, COPD and COVID-pneumonia.
Importantly, given both the acute nature of exacerbations which typically last 2-4 weeks and evidence from the COPD observational studies that much of the excess C5 and LTB4 is generated in the lung, a fast-acting inhaled delivery system is likely to be the preferred delivery route for exacerbating patients. Therefore, to optimize the potential clinical utility of nomacopan, Akari is now in development of an inhaled formulation of nomacopan with Inhalation Sciences AB.
Prior data indicate that nomacopan can be nebulized by conventional devices and achieve a median particle size suitable for deep lung delivery while maintaining its inhibitory activity. In addition, in preclinical models, C5 and LTB4 inhibition by nomacopan significantly decreases both eosinophils and neutrophils, key drivers of disease. Furthermore, in multiple preclinical lung models nomacopan is more effective than C5 and LTB4 inhibition alone, including leukotriene inhibitors, approved for treatment of the lung, such as Zileuton.
Akari is focused on developing nomacopan for treating exacerbations with a patient-friendly inhaled formulation for early intervention to prevent the potentially serious clinical consequences. Exacerbations are a significant driver of hospitalizations and mortality across multiple lung diseases, including severe asthma and COPD. For example, focusing on only asthma exacerbations in the U.S., the Centers for Disease Control and Prevention (CDC) estimates that over 11 million people reported having at least one asthma exacerbation in the last 12 months. Furthermore, there were 1.8 million emergency department visits, nearly 200,000 hospitalizations and about 3,500 deaths.
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. Nomacopan is currently being clinically evaluated in four areas: bullous pemphigoid (BP), thrombotic microangiopathy (TMA), as well as programs in the eye and lung.
