Daewoong to Start Phase 2 Trial of DWN12088 in IPF Patients This Year
The U.S. Food and Drug Administration (FDA) has given Daewoong Pharmaceutical the go-ahead to start a Phase 2 clinical trial to test the company’s experimental anti-fibrotic medication DWN12088 in people with idiopathic pulmonary fibrosis (IPF).
“The existing treatments of Idiopathic pulmonary fibrosis still have high unmet medical needs. We will strive to carry out our corporate mission to fulfill the unmet medical needs and lead the improvement of quality of human life by providing innovative new drugs to the patients with idiopathic pulmonary fibrosis through DWN12088,” Sengho Jeon, CEO of Daewoong, said in a press release.
The upcoming Phase 2 trial (NCT05389215), expected to launch in September, will be conducted at multiple sites in the U.S. and South Korea, according to Daewoong. The company expects it to enroll 102 people with IPF. Participants will be randomly assigned to take DWN12088 or a placebo for 24 weeks (about half a year).
The effect of treatment on lung function will be measured by tracking forced vital capacity (FVC), a lung function parameter that measures how much air a person can forcibly exhale after a deep breath.
IPF and other fibrotic (tissue scarring) diseases are marked by the overproduction of collagen, a structural protein that acts as a main component of scar tissue. DWN12088 is an experimental oral therapy designed to suppress the activity of a protein that’s important for collagen production called Prolyl-tRNA Synthetase (PRS), thereby lowering collagen levels and ultimately reducing fibrosis.
In animal models, co-treatment with DWN12088 and existing anti-fibrotic medicines led to “excellent anti-fibrotic and pulmonary function improvement,” according to Daewoong.
The upcoming Phase 2 trial builds off findings from a Phase 1 clinical trial program, conducted in Australia and South Korea, which assessed DWN12088’s safety profile and pharmacological properties in 162 healthy volunteers. Results showed the investigational treatment was generally well-tolerated and indicated it could decrease collagen production as intended.
DWN12088 was granted orphan drug designation by the FDA in 2019. This designation aims to incentivize the development of therapies for rare conditions, conferring among other incentives, a right of a seven-year market exclusivity if it’s ultimately approved.