CytoDyn Announces First Patient Enrolled in Phase 2 Trial for NASH - Seite 2

About Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic steatohepatitis (NASH) is a chronic liver disease characterized histologically by the presence of hepatic inflammation and cell injury (hepatocellular ballooning) due to hepatic fat accumulation (steatosis) equal or superior to 5 percent of hepatocytes. Unhealthy eating habits and lack of physical activity in the absence of excessive alcohol consumption contributes to the development of NASH. NASH can progress to high‐burden conditions such as cirrhosis, end-stage liver disease, and hepatocellular carcinoma (HCC). NASH is expected to become the leading cause of liver transplantation by 2020 in the United States.³ NALFD is the most common form of chronic liver disease, affecting about 30 to 40 percent of the population in the United States.⁴ An estimated 3 to 12 percent of the adult population in the United States have NASH,⁵ of which approximately 15 to 20 percent will likely progress to advanced fibrosis or cirrhosis.⁶ Despite its very high burden, there are currently no approved pharmacological therapies for NASH. Available therapies focus solely on treating NASH comorbidities, such as obesity, type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD), while NASH management options focus on lifestyle changes, based on diet and exercise, and control of the associated comorbidities. Lifestyle changes have demonstrated the greatest benefit in improving steatosis and mild fibrosis; however, as patients with advanced fibrosis due to NASH are at a significantly higher risk of liver‐related mortality, pharmacological treatments are urgently needed.⁷

About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals and clinics throughout the U.S., which are identified on the Company’s website under the “Clinical Trial Enrollment” section of the homepage; an interim analysis on the first 195 patients was conducted mid-October and may occur again now that the Company has reached enrollment of 293 patients.