D&D Pharmatech Granted Fast Track Designation from US FDA for DD01 for the Treatment of NASH/MASH
FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.
- FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.
- In animal models, DD01 treatment reduced hepatic steatosis, lobular inflammation, ballooning, and signs of fibrosis, all key diagnostic criteria MASH.
- “We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a Phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, Ph.D., CEO of D&D.
- DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming Phase 2.”