Foresee Pharmaceuticals to Present at the American Heart Association Annual Meeting Focusing on its ALDH2 activator FP-045 in Pulmonary Hypertension Associated with Interstitial Lung Disease

Taiwan - Foresee Pharmaceuticals (TPEx: 6576), ('Foresee') announced today that the company will be presenting at the American Heart Association (AHA) 2023 Annual Meeting taking place in Philadelphia, PA, from November 11-13, 2023.

The presentation will focus on Foresee's first-in-class oral ALDH2 activator, FP-045, and the clinical design of Phase 2 pulmonary hypertension associated with interstitial lung disease (PH-ILD) clinical study (WINDWARD study) currently in planning.

The oral presentation entitled: 'A New Therapeutic Paradigm for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) Windward Phase 2 Study' details the clinical design of the FP-045 WINDWARD Phase 2 study that will be conducted in collaboration with clinical experts in the area of pulmonary hypertension and interstitial lung disease.

Bassem Elmankabadi, M.D., Foresee's SVP of Clinical Development presenting the study, stated: 'The WINDWARD Phase 2 study is designed to evaluate the safety, tolerability and efficacy of FP-045 in patients with PH-ILD. Based on the mechanism of action and body of evidence of non-clinical pharmacology data of FP-045 on pulmonary artery wall thickness, we are very hopeful about the therapeutic promise of ALDH2 activation for PH-ILD patients and confident that the readout from this study will help guide future development and registrational efforts for FP-045 in this highly unmet patient population.'

'We are actively building our first/best-in-class oral ALDH2 franchise with multiple compounds across multiple indications, anchored by FP-045, a novel oral therapy which we are hopeful one day may become a valuable part of the PH-ILD treatment standard of care.', stated Dr. Ben Chien, Foresee's Chairman and CEO.

About FP-045 in PH-ILD

FP-045 is a first-in-class, potent oral aldehyde dehydrogenase 2 (ALDH2) activator. ALDH2 is a mitochondrial-matrix NAD-dependent enzyme expressed ubiquitously, particularly in organs and cells that require high mitochondrial oxidative phosphorylation under steady-state and/or specific activation states. ALDH2 plays a crucial role in oxidizing endogenous aldehyde products such as 4-hydroxy-2-nonenal-(4-HNE) and malondialdehyde-(MDA) that arise from lipid peroxidation caused by oxidative stress/reactive oxygen species-(ROS). Accumulation of 4-HNE and other reactive aldehydes, can disrupt mitochondrial aldehyde metabolism by directly inhibiting ALDH2 and consequently exacerbating mitochondrial stress. 4-HNE can stimulate the proliferation and migration of vascular smooth muscle cells. In patients with pulmonary hypertension-(PH), the buildup of 4-HNE in the pulmonary arteries has been identified as a significant contributor to disease progression. Our preclinical studies have demonstrated that Foresee ALDH2-activators, including FP-045, can attenuate pulmonary artery wall thickness caused by hypoxia in the rodent PH model. Additionally, FP-045 has been shown to improve respiratory function, reduce lung inflammation, injury, and fibrosis in rodent models of interstitial lung disease. The body of data strongly supports the therapeutic potential of FP-045 in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). As such, Foresee is seeking to evaluate FP-045 in a randomized Phase 2 study in patients with PH-ILD.

About ALDH2

ALDH2 (Aldehyde Dehydrogenase 2) is a mitochondrial matrix enzyme and key regulator of mitochondrial quality control systems/health and regulator of reactive aldehydes/carbonyls, oxidative stress, inflammation, and fibrosis. Activation of ALDH2 is a compelling therapeutic strategy for improving mitochondrial quality and regulatory mechanisms for treating the treatment of rare/orphan diseases and severe diseases of aging. The key role of ALDH2 in disease is supported by strong genetic/GWAS evidence related to a dominant-negative ALDH2 2 polymorphism.

About Foresee Pharmaceuticals Co., Ltd.

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee's R&D efforts are focused in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU and Taiwan and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI 21 mg. For the second indication of CAMCEVI 42 mg, central precocious puberty (CPP), the phase 3 clinical study, has been initiated. FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-045 is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 Fanconi Anemia study is currently being initiated, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning.

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