D&D Pharmatech, a biotech company, has been granted Fast Track designation by the US Food and Drug Administration (FDA) for its DD01 drug, aimed at treating adults with non-alcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This designation could potentially expedite the process of the drug review to meet the unmet requirements for serious diseases.
The FDA’s decision is based on data from a Phase 1 randomized, double-blind, placebo-controlled study that evaluated the safety and effectiveness of DD01 in overweight subjects with type 2 diabetes (T2D) and metabolic dysfunction-associated fatty liver disease (MAFLD). DD01 treatment was well tolerated and reduced hepatic steatosis (abnormal retention of lipids within liver cells) by over 50% in only four weeks.
D&D’s CEO, Dr. Seulki Lee, noted how MASH has a significant unmet need and several other clinical trials have proven that efficient reduction of excessive liver fat content can help manage MASH and liver scarring.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
