What is DUR-928 and The Benefits of Fast Track Designation
Post# of 70
(Total Views: 227)
Posted On: 05/05/2024 11:49:24 PM
DUR-928, also known as larsucosterol, is an investigational drug being developed by DURECT Corporation (DRRX) for the treatment of Alcoholic Hepatitis (AH) and it has received Fast Track designation from the FDA.
How Epigenetics Plays a Role:
DUR-928 is believed to work through epigenetics. Epigenetics refers to changes in gene expression that don't involve alterations in the DNA sequence itself. These changes can influence how cells function.
Here's a simplified explanation of how DUR-928 might work:
In AH, the liver becomes inflamed and damaged due to excessive alcohol consumption. This damage disrupts epigenetic processes, leading to abnormal gene expression and contributing to liver dysfunction. DUR-928 may help restore normal epigenetic patterns in liver cells, promoting healthy gene expression and potentially facilitating liver repair.
Importance of FDA Fast Track Designation:
The FDA Fast Track designation is designed to expedite the development and review of drugs that address serious or life-threatening conditions and have the potential to fill an unmet medical need. DUR-928, has received Fast Track designation from the FDA.
U.S. Market Size: Approx. 150,000 patients are hospitalized annually with AH. Currently there is a very high mortality rate associated with AH (30% at 90 days approx.). It is estimated that DUR-928 if approved may have the potential to generate $1B in annual sales.
How Epigenetics Plays a Role:
DUR-928 is believed to work through epigenetics. Epigenetics refers to changes in gene expression that don't involve alterations in the DNA sequence itself. These changes can influence how cells function.
Here's a simplified explanation of how DUR-928 might work:
In AH, the liver becomes inflamed and damaged due to excessive alcohol consumption. This damage disrupts epigenetic processes, leading to abnormal gene expression and contributing to liver dysfunction. DUR-928 may help restore normal epigenetic patterns in liver cells, promoting healthy gene expression and potentially facilitating liver repair.
Importance of FDA Fast Track Designation:
The FDA Fast Track designation is designed to expedite the development and review of drugs that address serious or life-threatening conditions and have the potential to fill an unmet medical need. DUR-928, has received Fast Track designation from the FDA.
U.S. Market Size: Approx. 150,000 patients are hospitalized annually with AH. Currently there is a very high mortality rate associated with AH (30% at 90 days approx.). It is estimated that DUR-928 if approved may have the potential to generate $1B in annual sales.
(1)
(0)