Coronavirus disease 2019 (COVID-19) is a highly contagious disease attributed to transmission of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).1 The disease originated in Wuhan China, in December 2019 and has spread globally, creating an ongoing pandemic.2,3 As of 28 April 2020, 3 million cases have been tracked in 185 countries. More than 200,000 deaths Have been recorded and greater than than 900,000 people have recovered after infection.4
The lungs are target organs for COVID‑19 infection, owing in large part to virus entering alveolar cells via the enzyme angiotensin-converting enzyme 2 (ACE2). As the disease progresses, respiratory failure and death may follow.5
Certain patients infected with COVID-19 develop an uncontrolled immune response ("cytokine storm") resulting in severe damage to lung tissue which could lead to respiratory failure. Early clinical studies conducted by doctors in China suggest that anti-IL6R mAbs may be used in clinical practice for treatment of COVID-19. Consequently, China's National Health Commission has recommended the use of Roche's blockbuster drug, Actemra® for treatment of patients infected with COVID-19, with serious lung damage and elevated IL-6 levels. Actemra was first approved by the FDA in 2010 for rheumatoid arthritis. Besides Actemra®, Sanofi and Regeneron are currently exploring Kevzara®, an FDA-approved anti-IL-6 receptor mAb therapy for rheumatoid arthritis, for treatment of severe COVID-19.
Tiziana Life Sciences intends to accelerate the development of hand-held nebulizer inhalation technology to deliver stable aerosols of TZLS-501 (anti-IL-6R mAb) and potentially other antiviral drugs such as remdesivir directly to lungs to treat COVID-19 by Q2 2021.Tiziana believes TZLS-501 (anti-IL6R mAb) combined with this newly introduced inhalation technology may rapidly inhibit inflammation in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression of COVID-19-mediated lung damage and death.
2. Hui DS, I Azhar E, Madani TA, Ntoumi F, Kock R, Dar O, et al. (February 2020). "The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health—The latest 2019 novel coronavirus outbreak in Wuhan, China". Int J Infect Dis. 91: 264–66. doi:10.1016/j.ijid.2020.01.009. PMC 7128332. PMID 31953166
3. "WHO Director-General's opening remarks at the media briefing on COVID-19". World Health Organization (WHO) (Press release). 11 March 2020. Archived from the original on 11 March 2020. Retrieved 12 March 2020
4. "COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU)". ArcGIS. Johns Hopkins University. Retrieved 29 April 2020.
5. Xu H, Zhong L, Deng J, Peng J, Dan H, Zeng X, et al. (February 2020). "High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa". International Journal of Oral Science. 12 (1): 8. doi:10.1038/s41368-020-0074-x. PMC 7039956. PMID 32094336