D&D Pharmatech said Thursday that DD01, an injectable treatment for metabolic-associated steatohepatitis (MASH) being developed by the company, has received fast-track designation from the U.S. Food and Drug Administration. This is the second MASH treatment developed by a Korean company to receive the FDA’s fast-track designation.
The FDA designates a new drug as fast-track when it determines that it needs to be developed quickly after screening a drug that shows superior efficacy for a serious or life-threatening condition.
Fast-tracked drugs receive full support from the FDA at every step, and close consultation with the FDA allows for faster development than would normally be possible.
In particular, they are eligible for Rolling Review, which allows them to submit and review the necessary documents for approval in stages. This dramatically reduces the overall development and approval time compared to a regular review, where all documents are prepared simultaneously.
Of the 55 new drugs approved by the FDA in 2023, about 65 percent were approved through expedited programs, including the fast track.
Metabolism-associated fatty liver disease (MAFLD), including MASH, is a common disease with a global prevalence of over 30 percent. Still, it is an area of high unmet need due to several failed treatments.
Recently, Madrigal Pharmaceuticals' Rezdiffra was approved as the first treatment for MASH, sparking a race to the market. Meanwhile, the recent series of excellent clinical results from follow-on drugs in the GLP-1 receptor agonist class has increased interest in this target.
DD01 is a once-weekly subcutaneous GLP-1/glucagon receptor dual agonist that utilizes D&D Pharmatech's long-acting pegylation technology to maximize therapeutic benefit by simultaneously acting on GLP-1 receptors, which suppress appetite and stimulate insulin secretion, and glucagon receptors, which rapidly break down fat. This mechanism is believed to directly target and improve fat storage in the liver, in addition to the efficacy of GLP-1 receptor mono-agonists.
"Based on the phase 1 results, we are preparing to initiate a phase 2 clinical trial of DD01," a D&D Pharmatech official said. "In particular, the phase 1 trial in obese and overweight patients with MAFLD demonstrated very rapid and potent liver fat reduction of up to 52.2 percent (high dose group) after only four weeks of treatment, raising expectations of a best-in-class drug.
The official continued, “Based on these results, we plan to initiate a U.S. phase 2 clinical trial in overweight/obese patients with MAFLD/MASH in the second quarter of this year."