Foresee Pharmaceuticals Announces Results from a Phase 1 Clinical Study, Highlighting Promising Safety, Tolerability and Pharmacokinetic Profile
TAIPEI, Taiwan, July 26, 2018 /PRNewswire/ — Foresee Pharmaceuticals Co., Ltd. (6576.TWO) (“Foresee”), announced today that it has successfully completed a Phase 1 multiple ascending dose (MAD) clinical study with FP-045, its novel, potent, oral small-molecule ALDH2 activator being developed for the treatment of peripheral arterial diseases and Fanconi Anemia. The objectives of the study was to evaluate the safety, tolerability, and pharmacokinetics of oral ascending doses of FP-045 in healthy subjects. A total of 24 subjects received 7 days of multiple oral doses of FP-045 at three different dose levels, or placebo in the MAD study.
The study results indicate that FP-045 was generally safe and tolerated up to the highest dose tested. No serious adverse events (SAE) were observed. All adverse events (AE) were considered mild or moderate in severity and recoverable at the end of the study. Pharmacokinetic behavior of FP-045 is consistent with once-a-day dosing. The data from these studies will inform the dose selection and study design for subsequent proof-of-concept/proof-of-mechanism studies testing the effect of FP-045 in different disease settings.
ALDH2 is a key mitochondrial regulator of toxic aldehyde metabolism. It plays a key role in the oxidation of endogenous aldehydic products that arise from lipid peroxidation under oxidative stress such as 4-hydroxy-2-nonenal (4-HNE) and malondialdehyde (MDA) as well as environmental aldehydes. Those toxic aldehydes are associated with many mitochondrial-mediated cardiovascular-metabolic diseases (PAD, NAFLD/NASH, heart failure, etc.) and rare diseases (Fanconi Anemia, Shwachman-Diamond Syndrome, Ataxia etc.). Activation of ALDH2 by its agonist can potentially accelerate toxic aldehyde metabolism and can theoretically provide the treatment of those diseases.
“Based on the data from preclinical animal studies, we chose to focus the development of FP-045 on Peripheral Artery Disease (PAD),” said Dr. Ben Chien, Chairman of Foresee, “Traditional treatment of PAD involves anticoagulants, which merely eases the symptoms. FP-045, on the other hand, can potentially provide treatment of the disease by preventing toxic aldehyde from accumulating. Another indication for FP-045 is Fanconi Anemia, a rare disease currently with no effective treatment. Patients with Fanconi Anemia are mostly diagnosed as children and have a medium lifespan of just 33 years.”
“With the positive results from Phase 1 clinical study, we are confident taking FP-045 into Phase 2 proof of concept in patient settings.” said Dr. Chien.
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 preclinical and clinical first-in-class NCE programs targeting 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 50-mg version has successfully completed a global Phase 3 Registration Study in advanced stage prostate cancer patients with regulatory submissions planned in 2018 and 25-mg version is expecting the last patient out in Phase 3 trial in late 2018; FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, moving into a Phase 2 proof-of-concept study; FP-045, a highly selective oral small molecule Agonist of ALDH2 currently completed Phase 1; and FP-004, a novel, subcutaneously injectable formulation of an opioid receptor agonist. Visit www.foreseepharma.com [http://www.foreseepharma.com/] for more information.
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