Taipei, Taiwan, December 4, 2017 – Foresee Pharmaceuticals Co., Ltd. (6576.TWO) (“Foresee”), announced today that it has successfully completed Phase 1 single and multiple ascending dose (SAD/MAD) clinical studies with FP-025, its novel, highly selective, oral small-molecule matrix metalloproteinase-12 (MMP-12) inhibitor being developed for the treatment of immune and fibrotic conditions, namely respiratory diseases. The objectives of these studies were to evaluate the safety, tolerability, and pharmacokinetics of oral ascending doses of FP-025 in healthy subjects. A total of 64 subjects received a single oral dose of FP-025 or placebo in the SAD study, and 24 subjects received 8 days of multiple oral dose of FP-025 or placebo in the MAD study, respectively. In addition, 8 subjects received FP-025 with and without food for the evaluation of food effect on the pharmacokinetics of FP-025.
The study results indicate that FP-025 was generally safe and tolerated up to the highest dose tested in both studies. No serious adverse events (SAE) were observed in these studies. All adverse events (AE) were considered mild in severity and recoverable at the end of the study. No significant difference in overall FP-025 exposure when subjects took FP-025 with or without food. A capsule formulation was able to deliver sufficient FP-025 exposure for future phases of clinical testing. The data from these studies will inform the dose selection and study design for a subsequent proof-of-concept/proof-of-mechanism study testing the effect of FP-025 in asthma patients.
“We are excited about the promising safety, tolerability, and pharmacokinetic profile of FP-025, a potential best-in-class MMP-12 inhibitor for the treatment of immune-fibrotic diseases, where exists significant unmet therapeutic needs,” said Dr. Ben Chien, Founder and Executive Chairman of Foresee, “FP-025 and follow-on compounds in our program, where rationally designed to overcome the selectivity limitations of MMP inhibitors previously developed with limited success by other companies. We are confident that our FP-025 program, with its high potency and selectivity MMP-12 inhibition profile, will address a key biological mechanism of multiple immune-fibrotic diseases”.
The next step for FP-025 will be to conduct a clinical Phase 2 proof-of-concept/proof-of-mechanism study in mild or moderate asthmatic patients in the Netherlands. Dosing of patients will commence in 1H, 2018. The safety, efficacy and pharmacodynamics/biomarker data gathered from this first Phase 2 study will further define a registration pathway and strategy, including the most compelling therapeutic indications to pursue.
About Foresee Pharmaceuticals Co. Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee’s R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery platform and derived drug products targeting specialty markets, and its transformative early stage preclinical and clinical NCE programs targeting inflammatory & fibrotic diseases and other disease areas with highly unmet needs. Foresee's product portfolio includes late stage and early stage programs such as FP-001, a stable, ready-to-use version of leuprolide mesylate depot for injection, which has successfully completed a global Phase 3 Registration Study in advanced stage prostate cancer patients with regulatory submissions planned in 2018, FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, moving into a Phase 2 proof-of-concept study, and FP-045, a highly selective oral small molecule Agonist of ALDH2 (Aldehyde Dehydrogenase 2), a mitochondrial enzyme acting as a key regulator of reactive aldehydes, oxidative stress and mitochondrial-mediated diseases such as liver, muscle and cardiovascular diseases, currently in Phase 1. Please visit Foresee’s website at www.foreseepharma.com.
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