IPF Therapy DWN12088 Is on FDA’s Fast Track
The U.S. Food and Drug Administration (FDA) has given fast-track designation to DWN12088, an experimental anti-fibrotic medication that Daewoong Pharmaceutical is developing to treat idiopathic pulmonary fibrosis (IPF).
Fast track designation is given to therapies that are intended to treat serious conditions and fill an unmet medical need. The goal is to ensure that patients have access to these important medications as early as possible. The designation also grants Daewoong, as the therapy’s developer, access to more frequent meetings and communication with the FDA throughout the therapy’s development process.
Therapies given fast-track designation also are eligible for FDA accelerated approval and priority review — other mechanisms to expedite the development and review of new therapies — if certain criteria are met.
According to Daewoong, this is the first time that a company based in South Korea has been granted FDA fast-track designation for a potential IPF therapy.
“Idiopathic pulmonary fibrosis is a disease with high unmet medical needs despite the existence of treatments. Daewoong Pharmaceutical will work closely with the FDA to accelerate development and will do its utmost so that this innovative drug can be commercialized as soon as possible,” Seng-Ho Jeon, Daewoong’s CEO, said in a press release.
DWN12088 is an experimental oral therapy designed to block the activity of a protein called Prolyl-tRNA Synthetase, or PRS, which is important for the production of collagen — a structural protein that is the major component of scar tissue. Fibrotic diseases such as IPF are characterized by an overproduction of collagen; by lowering collagen production, DWN12088 is expected to ease fibrosis (tissue scarring).
The FDA’s decision to grant fast-track designation to DWN12088 was based in part on data from a Phase 1 clinical trial conducted in Australia, which assessed the safety and tolerability of the experimental treatment in healthy adults.
Results showed that DWN12088 was overall safe and well-tolerated. The most common side effects were digestive complaints, and no serious side effects were reported. The data also indicated that the experimental treatment decreased collagen production as intended.
The FDA recently cleared Daewoong to start a Phase 2 trial (NCT05389215) that will test DWN12088 against a placebo in people with IPF. The study is expected to launch later this year.
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