Leuprolide Mesylate

TAIPEI, April 29, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576) ("Foresee") announced today that it will actively participate in and present two posters at the 2024 American Thoracic Society (ATS) International Conference, which will be held in San Diego, CA, from May 17 to 22, 2024. The first poster is titled: "A Multinational Phase 2, Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study to Evaluate the Safety and Efficacy of FP-045, An Aldehyde Dehydrogenase 2 Activator in Patients with Pulmonary Hypertension Associated with Interstitial Lung Disease", is a testament to our collaborative approach with clinical experts in the area of pulmonary hypertension and interstitial lung disease in designing the WINDWARD Phase 2 study. Poster Board Number: P1360 Poster Session: A32- Bench to Bedside in ILD Date and Time: Sunday, May 19, 2024, from 11:30 AM-1:15 PM PT Location: San Diego Convention Center, Area L (Hall H, Ground Level) () The second poster is titled: "Effect of aderamastat (FP-025), A Selective MMP-12 Inhibitor, on Allergen-induced Airway Responses in Subjects with House-dust Mite Allergic Mild Asthma and Blood Eosinophilia" is the result of a collaboration with clinical experts in the area of asthma and pulmonology in the Netherlands, and focuses on the promising primary results from the assessment of the efficacy of multiple oral doses of aderamastat in HDM-allergic asthma patients. Poster Board Number: P671 Poster Session: C35- Innovative Biomarkers to Identify Allergic Inflammation Date and Time: Tuesday, May 21, 2024, from 11:30 AM-1:15 PM PT Location: San Diego Convention Center, Area F (Hall A-B2, Ground Level) () "The WINDWARD Phase 2 study is designed to evaluate the safety, tolerability, and efficacy of FP-045 in patients with PH-ILD. With compelling non-clinical pharmacology data demonstrating FP-045's impact on pulmonary artery wall thickness, we are optimistic about the therapeutic promise of ALDH2 activation for PH-ILD patients. We are confident that the readout from this study will help guide future development and registrational efforts for FP-045 in this highly unmet patient population.", said Bassem Elmankabadi, M.D., SVP of Clinical Development at Foresee. "We are pleased to have the opportunity to share promising data related to the previously announced aderamastat topline Phase 2 proof-of-concept study. The data reinforces MMP-12's significant role in pivotal inflammatory pathways to asthma and other interstitial lung diseases," said Dr. Yisheng Lee, Chief Medical Officer at Foresee. "With this Phase 2 proof-of-concept study, our objective was that aderamastat was well-tolerated and that the inhibition of MMP-12 in humans was in line with the MMP-12 single-nucleotide polymorphism (SNP) data, human expression data, and animal pharmacology models. We could not be more confident with the role and importance of MMP-12 in immune-fibrotic diseases, particularly in the lung.", added Dr. Lee. "We are actively building a broad first/best-in-class franchise leveraging our innovative chemical entities, MMP-12 inhibitors, and ALDH2 activators. With a diverse portfolio spanning multiple therapeutic areas, we are poised to address unmet medical needs across a spectrum of health challenges.", said Dr. Ben Chien, Foresee's Chairman and CEO. The posters will become available on the Foresee website after the conference. 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 and 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. The activation of ALDH2 is a compelling therapeutic strategy for improving mitochondrial quality and regulatory mechanisms for treating 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 a deramastat and MMP-12 Aderamastat is a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. MMP-12 plays a role in asthma pathophysiology and is associated with disease severity. Aderamastat showed sustained anti-inflammatory effects and attenuated allergen-induced histopathology in a house dust mite (HDM) mouse model. A Phase 2 allergen challenge asthma proof-of-concept study has been completed. The key role of MMP-12 in disease is supported by single-nucleotide polymorphisms/genetic evidence related to inflammatory-fibrotic diseases, including asthma and COPD. MMP-12 is a key immune-fibrotic modulator secreted by macrophages and a key regulator of macrophage, neutrophil, and lung epithelial cell biology. It is increasingly recognized as a key marker of inflammatory exacerbations and fibrosis. 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 on 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 being prepared 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 has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-020, a follow-on oral MMP-12 inhibitor currently in Phase 1, with development targeted in severe asthma and COPD. 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.

The independent Data and Safety Monitoring Board (DSMB) recommended the continuation of patient enrollment as planned. There has been no safety concern with the use of Leuprolide (FP-001) injectable Emulsion in pediatric CPP patients. TAIPEI, April 1, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces the positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial with a minor amended protocol. The Casppian Phase 3 study is an open-label, multicenter, multinational 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). 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. "We are pleased to receive the positive recommendation from the DSMB to continue our clinical trial. Ensuring the safety of the children participating in our trial is paramount and we continue to be dedicated to maintaining the highest standards of safety and ethical conduct throughout this clinical trial. The top-line results from this trial are anticipated in 2025.", said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development at Foresee Pharmaceuticals. "Foresee's Leuprolide 42 mg formulation (FP-001) dosed subcutaneously every 6 months, has the potential to become the only ready-to-use Leuprolide 6-month long-acting injection on the market, providing benefit to stakeholders in the CPP community. This positive recommendation brings us closer to our goal of delivering safe and effective treatment for children in need," said Dr. Ben Chien, Foresee's Chairman and CEO. "We look forward to establishing commercial partnership soon for the potential future commercialization of FP-001, in CPP indication." 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 too early, 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. Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP. 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 on 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 being prepared 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 has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-020, a follow-on oral MMP-12 inhibitor currently in Phase 1, with development targeted in severe asthma and COPD. 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.