Foresee Pharmaceuticals Announces First Patient Dosed in the Phase 2 WINDWARD Study of the ALDH2 Activator Mirivadelgat for Patients with Pulmonary Hypertension-Associated Interstitial Lung Disease (PH-ILD)

• The WINDWARD study is a multinational, double-blind, 3-arm Phase 2 study to evaluate the safety and efficacy of mirivadelgat in adult subjects with PH-ILD.
• Mirivadelgat is a first-in-class oral small molecule with a novel mechanism of action, having the potential to provide a disease-modifying treatment for patients with PH-ILD, through its effect on both the cardiovascular and interstitial lung disease components of PH-ILD.
• PH-ILD is an underserved severe disease. Approximately 30% of ILD patients develop PH, with up to 100,000 diagnosed PH-ILD patients in the U.S.¹

TAIPEI, May 15, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced the dosing of the first patient in the Phase 2 pulmonary hypertension-associated interstitial lung disease (PH-ILD) study (WINDWARD study).

The WINDWARD study is a Phase 2, multinational, double-blind, 3-arm study to evaluate the safety and efficacy of mirivadelgat (FP-045), an oral aldehyde dehydrogenase 2 activator, in adult subjects (aged 18 to 85 years) with PH-ILD.

The WINDWARD Phase 2 study is designed for 16-weeks to evaluate the safety and efficacy of mirivadelgat administered orally compared to placebo in 99 patients (33 evaluable subjects in each cohort) with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The primary endpoint will be the mean change from baseline to week-12 in the Pulmonary Vascular Resistance (PVR) assessed by right heart catheterization for mirivadelgat versus placebo in subjects with PH-ILD. Multiple secondary endpoints will be included, such as the mean change from baseline to week-12 of long-term prognostic risk factors, e.g., N-terminal pro-brain natriuretic peptide (NT-ProBNP) in subjects with PH-ILD and the mean change from baseline to week-12 of the 6-minute walk distance in subjects with PH-ILD.

"Dosing of the first patient in the WINDWARD study is a testament to the dedication of our team to finding a potential therapy for patients with PH-ILD. 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. 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 (PH-ILD)." Stated Bassem Elmankabadi, M.D., Senior Vice President, Clinical Development.

"Mirivadelgat (FP-045) is a scientific breakthrough mechanism targeting ALDH2 activation. Preclinical data demonstrated mirivadelgat's disease modifying activity on lung fibrosis, heart hypertrophy, and fibrosis as well as pulmonary and cardiac function. The WINDWARD trial will validate its clinical impact, potentially ushering in a new treatment era for patients with limited options. This milestone underscores our leadership in leveraging cutting-edge science to improve lives." Stated Dr. Wenjin Yang, Ph.D., Chief Scientific Officer.

Dr. Ben Chien, Ph.D., Chairman and CEO of Foresee Pharmaceuticals, stated: "Today's achievement reflects Foresee's unwavering mission to pioneer life-changing therapies. The initiation of Phase 2 for mirivadelgat is a strategic milestone that brings us closer to delivering hope to millions affected by the PH-ILD condition. We thank the investigators, patients, and our talented team for their relentless pursuit of innovation."

About PH-ILD

Pulmonary hypertension (PH) leads to abnormally high mean pulmonary arterial pressure (mPAP), and it is a complex and devastating disease that causes progressive vasoconstriction and vascular remodeling of the distal pulmonary arteries. A significant proportion of patients with Interstitial Lung Disease (ILD), a group of severe, progressive lung disorders that can damage the lungs and make it harder to breathe, such as Idiopathic pulmonary fibrosis (IPF), pulmonary fibrosis (PF), combined pulmonary fibrosis and emphysema (CPFE), and connective tissue disease (CTD) will develop PH as a result of their arteries in the lungs tightening so that blood can only go to areas of the lungs that are receiving the most air and oxygen. This tightening leads to high blood pressure throughout the lungs. The only approved treatment for PH-ILD is inhaled treprostinil.

About Mirivadelgat

Foresee is positioning mirivadelgat, as a first-in-class, once-a-day oral drug for the treatment of PH-ILD and other rare/severe diseases. Mirivadelgat and other Foresee oral ALDH2 activators have demonstrated compelling non-clinical efficacy across a broad panel of animal pharmacology and translational models, highlighting the pivotal role of ALDH2 activation in the modulation of mitochondrial stress, energetics, tissue inflammation, fibrosis, and muscle function, amongst some of its key functions. The efficacy observed in models of heart failure, pulmonary hypertension, muscle dysfuntion and pulmonary fibrosis/interstitial lung disease, is highly impressive, demonstrating disease modifying efficacy on lung fibrosis, heart hypertrophy and fibrosis as well as pulmonary and cardiac function. The body of data strongly supports the ongoing Phase 2 WINDWARD study.

About Foresee Pharmaceuticals

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets, and secondly, its transformative preclinical and clinical first-in-class oral NCE programs targeting rare and severe disease areas with high unmet needs.

Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and launched in the U.S. and Germany. The China MAA of CAMCEVI 6-month was accepted for a substantive review. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted and accepted for review with a PDUFA date of August 29, 2025, and the EU regulatory submission for the 3-month version of CAMCEVI has been completed in March 2025, and accepted for scientific assessment. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma, COPD, and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients has been initiated. Building on the compelling biology of ALDH2 and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. www.foreseepharma.com

SOURCE Foresee Pharmaceuticals Co., Ltd.