MMP12

TAIPEI, Oct. 30, 2023 /PRNewswire/ -- 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. Details of the oral presentation are as follows: Title: A New Therapeutic Paradigm for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) Windward Phase 2 Study Date: Saturday, November 11, 2023 T ime: 11:15 - 11:45 Eastern Location: Pennsylvania Convention Center, Heart Theater‚ Science and Technology Hall‚ Level 2, HT.01 The presentation slides will become available on the Foresee website after the presentation. 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. SOURCE Foresee Pharmaceuticals Co., Ltd.

Multicenter, multinational Phase 3 Casppian study will evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg-controlled release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP). Foresee's leuprolide injectable emulsion, 42 mg (marketed under the brand name Camcevi®) is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer. Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP. TAIPEI, Oct. 13, 2023 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces that the first patient has been dosed in the Casppian Phase 3 registration study. Continue Reading "The Casppian Phase 3 study is an open-label, multicenter clinical trial to evaluate the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg-controlled release in patients with central (Gonadotropin- Dependent) precocious puberty (CPP). The study duration is 48 weeks. The study's Primary endpoint is the percentage of patients with serum LH concentration < 4 mIU/mL 30 minutes following a GnRH agonist stimulation test at Week 24. Leuprolide (FP-001) 42 mg will be considered effective for the treatment of children with CPP if ≥ 80% of patients exhibit LH suppression < 4 mIU/mL at Week 24. The Casppian study will also test key secondary endpoints like the changes in bone ages, growth rate, and physical signs of puberty assessed by Tanner stages from baseline to the end of the study at 48 weeks, which the FDA has accepted," said Bassem Elmankabadi, M.D., Senior Vice President Clinical Development at Foresee Pharmaceuticals. "GnRH agonists, including leuprolide, are the standard of care for CPP patients. Foresee's FP-001, 42 mg subcutaneously every 6 months, has the potential to become the only six-month, ready-to-use leuprolide, providing benefit to multiple stakeholders in the CPP community." said Dr. Ben Chien, Foresee's Chairman, and CEO. "It is exciting to be expanding the therapeutic and commercial potential of FP-001 with the initiation of the Casppian study, and we look forward to establishing a commercial partnership for the potential future commercialization of FP-001, specifically in CPP." About CPP GnRH-dependent CPP is a condition that causes early sexual development in girls and boys, as their "hypothalamus - pituitary gland - gonadal axis" is activated prematurely, causing children to enter puberty prematurely, between 2 years and 9 years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety, and depression, which may negatively impact their quality of life. According to the NORD (National Organization for Rare Disorders) website, CPP occurs in 1 out of 5,000 to 10,000 children. It is estimated that approximately 80% - 90% of CPP cases are idiopathic, especially in females, with a female-to-male ratio of around 20: 1. 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. The U.S. regulatory submission is anticipated in 2024. The second indication of CAMCEVI® 42 mg – central precocious puberty (CPP), the Casppian phase 3 clinical study, has been initiated. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, a Phase 2 proof-of-concept study in allergic asthmatic patients has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is currently being initiated, and a Phase 2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning. SOURCE Foresee Pharmaceuticals Co., Ltd.

TAIPEI, Taiwan, Sept. 30, 2023 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announced today that the company will present the clinical design of the FP-045 Phase 1/2 clinical Fanconi anemia clinical study (FuschiA study) currently being initiated, at the Fanconi Anemia Research Fund (FARF) 2023 Scientific Symposium taking place in Vancouver, BC, Canada from September 28-October 1, 2023. The oral presentation entitled: "A Clinical Trial Evaluating the Safety & Biological Activity of FP-045, an ALDH2 Activator, in Fanconi Anemia Patients" details the clinical design of the FuschiA Phase 1/2 study that will be conducted in collaboration with clinical experts in the area of Fanconi anemia (FA) from Stanford University, Memorial Sloan Kettering Cancer Center and the University of Minnesota. Dr. Yisheng Lee, Foresee's Chief Medical Officer presenting the study, stated: "The FuschiA study is a first-in-patient clinical trial to test the safety and tolerability of FP-045 and to obtain data on preliminary biological activity in FA patients. We are very hopeful in the therapeutic promise of ALDH2 activation for FA patients and are confident the information from this study will help guide future registrational efforts for FP-045 in this highly unmet patient population." "We are strong supporters of FARF's mission and are working closely with all stakeholders and patients in the FA community, as we are committed to bringing forward FP-045, a novel oral therapy which we are hopeful one day may become a valuable part of the FA patient treatment standard of care.", stated Dr. Ben Chien, Foresee's Chairman and CEO. Details of the oral presentation are as follows: Title: A Clinical Trial Evaluating the Safety & Biological Activity of FP-045, an ALDH2 Activator, in Fanconi Anemia Patients Date: Saturday, September 30, 2023 T ime: 11:10 - 11:25 PST Location: Sheraton Vancouver in Grand Ballroom AB The presentation slides will become available on the Foresee website after the presentation. More information about the FuschiA trial is available at: About FP-045 in Fanconi anemia FP-045 is a first-in-class, potent oral aldehyde dehydrogenase 2 (ALDH2) activator. A dominant-negative allele of ALDH2 in Fanconi anemia (FA) patients is associated with accelerated progression of bone marrow failure, suggesting ALDH2 activation might be a potential therapeutic approach in FA. Laboratory studies demonstrate that FP-045 decreases aldehyde-induced toxicity in lymphoblastoid cell lines from FA patients. Preclinical animal experiments also demonstrated that sustained activation of ALDH2 can prevent Hematopoietic stem cell (HSC) loss in FA, resulting in improved HSC numbers and functions. To allow for clinical testing in FA patients, single ascending dose (SAD), multiple ascending doses (MAD) 7 days studies, and a 28 days dosing study of FP-045 have been conducted in healthy human subjects that showed safety and tolerability of FP-045 following oral administration. Dose-proportionality and time-stability of the pharmacokinetics of FP-045 in humans were also established. Based on these favorable results from healthy subjects and further discussions with regulators, Foresee is initiating the FuschiA study, a first-in-patient Phase 1/2 clinical trial to test the safety and tolerability of FP-045 and to obtain data on preliminary biological activity in FA patients. 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. The second indication of CAMCEVI® 42 mg – central precocious puberty (CPP), the Casppian phase 3 clinical study, has been initiated. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, 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 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is currently being initiated, and a P2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning. SOURCE Foresee Pharmaceuticals Co., Ltd.