Foresee Pharmaceuticals Co., Ltd. (6576.TWO) today announced that all patients had completed participation in its Phase 3, multinational, multicenter trial of FP-001/LMIS (Leuprolide Mesylate Injectable Suspension) 25 mg, a three-month, ready-to-use subcutaneous depot formulation for the treatment of advanced prostate cancer.
The open-labeled, single arm study enrolled a total of 144 prostate cancer patients in 21 sites in the U.S., South Korea, and Europe. Each patient received two consecutive injections of LMIS 25 mg for an aggregated treatment duration of six months. Topline results from this study are expected in the first quarter of 2019.
“We are very pleased to have completed another key program milestone on schedule. With topline data expected in Q1/2019, we are aggressively preparing for regulatory submissions of this 3-month ready-to-use depot soon following the submission of the LMIS 50 mg 6-month ready-to-use depot which previously completed the Phase 3 registration study with great success,” said Dr. Ben Chien, Chairman of Foresee. “Together these two LMIS products will constitute a new generation, differentiated, leuprolide-based uro-oncology franchise.”
“The commercial success of LMIS will help catalyze and push forward our development-stage NCE programs, including FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in Phase 2 proof-of-concept study, and FP-045, a highly selective oral small molecule allosteric activator of the mitochondrial target, ALDH2, for which a Phase 2 study is currently in planning for mitochondrial-mediated diseases such as Peripheral Artery Disease and Fanconi Anemia,” 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 technology and derived drug products targeting specialty markets, and its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high 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, of which the 6-month depot version has successfully completed a global Phase 3 Registration Study in advanced stage prostate cancer patients with regulatory submissions planned in 2019 and the 3-month depot version has completed Phase 3 in November 2018; FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in a Phase 2 proof-of-concept study; FP-045, a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 2 study is currently in planning (mitochondrial-mediated diseases, including Peripheral Artery Disease and Fanconi Anemia); and FP-004, a novel, subcutaneously injectable depot product in development for the treatment of opioid use disorder and pain. Visit www.foreseepharma.com for more information.
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