Foresee Pharmaceuticals Announces Dosing of First Patient in Phase 2/3 Clinical Trial of FP-025 for Treatment of COVID-19 Associated ARDS

TAIPEI,March 28,2021 -- Foresee Pharmaceuticals Co.,Ltd. (6576.TWO) ("Foresee"),today announced the initiation of patient dosing in the Phase 2/3 clinical trial of FP-025,its highly selective oral MMP-12 inhibitor,in adult patients with severe to critical COVID-19 with associated Acute Respiratory Distress Syndrome (ARDS).

Dr. Ben Chien,founder and Chairman of Foresee,said,"We are pleased to begin this Phase 2/3 study of FP-025. FP-025 showed significant therapeutic efficacy inpreclinical inflammation and fibrosis models of the lung,suggesting that FP-025 may potentially avert the lung injury and fibrosis caused by COVID–19 infections. We look forward to evaluating the potential of FP-025 in the fight against the pandemic."

The Phase 2/3 trial is a randomized,double-blind,placebo-controlled,multicenter study to evaluate the efficacy and safety of FP-025. The Phase 2 part will be conducted in the United States. Approximately 99 patients (18-65 years) with a diagnosis of severe to critical COVID 19 with associated ARDS will be randomized in a 1:1:1 ratio to receive FP-025 100 mg,FP-025 300 mg,or placebo twice daily for 28 days. The primary outcome measures of the trial include the proportion of patients alive and not requiring non-invasive or invasive ventilation at Day 28. An interim analysis is planned at the end of Phase 2 trial,of which the efficacy results are expected in the fourth quarter of 2021.

Based on the primary analysis results from Phase 2,an optimal dose will be selected to carry into Phase 3 of the study. Approximately 300 patients will be randomized in a 1:1 ratio to receive FP–025 or placebo for 28 days. For more information about the clinical trial,see www.clinicaltrials.gov,identifierNCT04750278.

About FP-025

FP 025 is a selective small molecule inhibitor of MMP-12. Key functions of MMP-12 include the modulation of numerous components of the extracellular matrix,namely elastin and collagen. MMP-12 also modulates effector proteins and cells,such as the influx of monocytes and macrophages involved in inflammation and fibrosis. MMP-12 is mainly produced and secreted by activated macrophages,as well as by pulmonary epithelial cells and chondrocytes. As such,MMP-12 is implicated in many inflammatory and fibrotic diseases of the lung,and a potential mediator of both inflammatory responses and structural remodeling that can occur in patients with COVID-19 associated respiratory disease.

FP–025 was shown to have effects in preclinical inflammation and fibrosis models,and is safe and efficacious in preclinical and clinical studies. FP-025 is currently being given at 400 mg BID for 12 days in a clinical study of patients with asthma; the study is ongoing and remains blinded.

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 with derived drug products targeting specialty markets,and secondly 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. FP-001 – stable,ready-to-use versions of leuprolide mesylate for injection,for which regulatory approval reviews are currently underway in US and EU for the 6-month product and regulatory submissions for 3-month product are in preparation. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases,currently in Phase 2/3 studies,including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). FP-045 – a highly selective oral small molecule allosteric activator of ALDH2,a mitochondrial enzyme,for which a Phase 1b/2 study is currently planned for Fanconi Anemia. FP-004 – a novel,subcutaneously injectable product in development for the treatment of opioid use disorder and pain. www.foreseepharma.com

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