Although we are now months into the global pandemic, new information emerges daily. Currently, COVID-19 is responsible for over 29 million cases globally, with 926,000 associated deaths. In the United States alone, there are 6.57 million cases and 194,000 deaths. Many of these are attributed to systemic problems such as respiratory distress and organ damage. However, biopharmaceutical company Akari Therapeutics recently announced the onset of an international clinical development program for nomacopan as a potential treatment for COVID-related pneumonia.
Developed by Akari Therapeutics, nomacopan is described as:
a second-generation complement inhibitor [which] acts on complement component-C5, preventing release of C5a and formation of C5b–9, and also inhibits leukotriene B4, or LTB4, activity, both elements that are co-located as part of the immune/inflammatory response. Nomacopan is a recombinant small protein derived from a protein originally discovered in the saliva of the Ornithodoros moubata tick, where it modulates the host immune system to allow the parasite to feed without alerting the host to its presence or provoking an immune response.
In many cases, respiratory distress and pneumonia in patients with severe COVID-19 result from an overactive immune response. Thus, nomacopan would prevent severe inflammation and the development of pneumonia. Further, it would hopefully reduce lung and organ damage, and improve patient outcomes.
To determine the safety, efficacy, and tolerability of nomacopan, researchers hope to hold clinical trials in the United States, United Kingdom, and Brazil. Akari Therapeutics creates their clinical development program through determining biomarkers, completing proof-of-concept studies, conducting randomized trials, and then seeking regulatory approval. Currently, in the United Kingdom, researchers collected data on 50 patients with COVID-related pneumonia; similar collections have occurred in the U.S. and Brazil. This will ultimately help researchers determine which patients are most likely to benefit from nomacopan.
Once full trials are launched, patients will receive oxygen, as well as subcutaneously administered nomacopan daily for a 2-week period. These trials will test the drug’s ability to support respiratory health, as well as track related intubation and COVID-associated deaths.