Foresee Pharmaceuticals announced on the 28th that its new drug FP-045, designed to treat pulmonary hypertension (PH) caused by interstitial lung disease (ILD), has been approved by the U.S. FDA to enter Phase II clinical trials. The trial plans to recruit approximately 126 participants; Taiwan will first recruit about 39 measurable subjects for interim analysis to evaluate the drug’s efficacy and safety before extending the trial to the United States and other countries.
This Phase II clinical trial will be a randomized, double-blind, placebo-controlled, multiple-dose oral drug study to assess the safety and efficacy of FP-045 in patients with pulmonary hypertension due to interstitial lung disease.
According to Foresee Pharmaceuticals, the DelveInsight research report estimates that in 2021, there were approximately 166,000 PH-ILD patients in major countries, and in 2022, the global PH-ILD market value was around $1.263 billion. This market is expected to continue growing.
Recent evidence increasingly suggests that oxidative stress is crucial in the pathological remodeling of the pulmonary vascular system, and excessive lipid peroxidation is one of the causes of abnormal proliferation of pulmonary arterial endothelial smooth cells. Therefore, ALDH2 activators (including FP-045 series compounds) have shown significant activity in pharmacological models for pulmonary hypertension (PH), heart failure (HF), and interstitial lung disease (ILD). By activating ALDH2, these compounds have demonstrated disease-mitigating effects on pulmonary fibrosis, cardiac hypertrophy, and fibrosis, as well as improvements in lung and heart functions. The clinical development of FP-045 is progressing smoothly and it is expected to become the first oral drug specifically for treating PH-ILD, with potential expansion to other types of pulmonary hypertension treatments.
Foresee Pharmaceuticals explained that for patients with interstitial lung disease, current treatments mainly focus on alleviating symptoms, improving quality of life, and slowing disease progression. Treatments often include steroids, immunosuppressants, or oxygen therapy. Additionally, United Therapeutics' two drugs for treating Group 1 pulmonary hypertension, Tyvaso inhalation solution and Tyvaso DPI dry powder formulation, were approved by the U.S. FDA in 2021 and 2022, respectively, expanding their use to treat Group 3 pulmonary hypertension patients, and are currently approved treatments for PH-ILD.
Since many patients still have poor prognoses leading to rapid disease progression, especially those with Group 3 pulmonary hypertension who may respond poorly to treatment, developing new drugs for pulmonary hypertension is crucial.
Resource (mandarin): 逸達治肺高壓新藥 美國FDA核可進行二期臨床
