First patient dosed in Phase 2 trial testing mirivadelgat for PH-ILD
Assessing impact of treatment on pulmonary vascular resistance is study's goal
The first participant has been dosed in a Phase 2 trial testing the experimental oral therapy mirivadelgat in people with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The Phase 2 trial, called WINDWARD (NCT06475781), aims to enroll about 126 adults with PH-ILD, ages 18 to 85. Participants will be randomly assigned to take mirivadelgat at one of two doses, or a placebo, once daily. The study’s main goal is to assess the impact of mirivadelgat treatment on pulmonary vascular resistance (PVR), a measure of how much force is needed to move blood through the lungs’ vessels, after about three months.
The WINDWARD study is actively recruiting participants at nine sites in Taiwan. The clinical trial is sponsored by Foresee Pharmaceuticals, the company developing mirivadelgat.
“This trial builds on rigorous foundations and incorporates a robust design to evaluate mirivadelgat’s safety and efficacy across several clinical endpoints, including improvements in peripheral vascular resistance (PVR) and functional capacities in PH-ILD patients,” Bassem Elmankabadi, MD, senior vice president of clinical development at Foresee, said in a company press release.
“We are committed to executing this study efficiently, generating high-quality evidence, and ensuring patient safety to advance mirivadelgat as a transformative option for patients with pulmonary hypertension-associated interstitial lung disease,” Elmankabadi added.
ILDs marked by inflammation, scarring in the lungs
Interstitial lung diseases, or ILDs, are a group of disorders marked by inflammation and scarring in the lungs. This can often lead to pulmonary hypertension, where the pressure in the blood vessels that carry blood through the lungs is abnormally high, putting strain on the heart.
Mirivadelgat is designed to activate a protein called aldehyde dehydrogenase 2 (ALDH2), which is known to help protect the heart and plays a role in the development of PH-ILD.
Preclinical data suggest ALDH2 activation may be disease-modifying in pulmonary hypertension via reduction of lung fibrosis, as well as beneficial to heart and pulmonary artery function, according to the company.
“Mirivadelgat (FP-045) is a scientific breakthrough mechanism targeting ALDH2 activation,” said Wenjin Yang, PhD, chief scientific officer of Foresee. “Preclinical data demonstrated mirivadelgat’s disease-modifying activity on lung fibrosis [scarring and thickening], heart hypertrophy [enlargement], and fibrosis, as well as pulmonary and cardiac function. The WINDWARD trial will validate its clinical impact.”
Ben Chien, PhD, chairman and CEO of Foresee, added the launch of the WINWARD study “is a strategic milestone that brings us closer to delivering hope to millions affected by the PH-ILD condition.”
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