Leuprolide Mesylate

TAIPEI, Oct. 29, 2024 /PRNewswire/ -- Foresee Pharmaceuticals Co., Ltd. (TPEx: 6576), ("Foresee") announced today that it has submitted a 505(b)(2) New Drug Application for the 3-month version of CAMCEVI, a ready-to-use 3-month depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer. This NDA submission is supported by a previously successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint. "Following the successful launch of CAMCEVI 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of CAMCEVI NDA to the U.S. FDA. This marks a significant milestone in our efforts to expand treatment options for patients with advanced prostate cancer. We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026, providing patients with its differentiated ready-to-use profile," said Dr. Ben Chien, Founder and Chairman of Foresee. 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 (LAI) 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 6-month depot formulation, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan and Israel and launched in the U.S. in April 2022. Additionally, the U.S. NDA for the 3-month version of CAMCEVI has been submitted, while the EU regulatory submission for the 3-month version of CAMCEVI is still under preparation. For the second indication of CAMCEVI 6-month depot formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study, is ongoing. Another indication of CAMCEVI 6-month depot formulation, premenopausal breast cancer, the Phase 3 clinical trial in China is ongoing as well. Aderamastat (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 had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, for which a Phase 1 study in healthy volunteers has been successfully completed, with development targeted in severe asthma, COPD and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TAIPEI, Oct. 20, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced the successful completion of its Phase 1 single and multiple ascending dose (SAD/MAD) clinical study in Australia with linvemastat (FP-020), its novel, highly selective, oral small-molecule matrix metalloproteinase-12 (MMP-12) inhibitor. The objectives of the study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of oral ascending doses of linvemastat (FP-020) in healthy subjects. This Phase 1 clinical trial, which has been successfully completed, consists of two parts. Part 1 is a SAD study in which 40 subjects were randomized to receive a single oral dose of linvemastat (FP-020) or placebo, followed by Part 2, a MAD study, in which 24 subjects were randomized to receive once daily oral dose of linvemastat (FP-020) or placebo for 10 days. "The overall safety profile for linvemastat in healthy volunteers is a testament to its potential. It suggests that linvemastat was well tolerated, with no Serious Adverse Events reported. The most common Treatment Emergent Adverse Events (TEAEs) were mild nausea and headache and were recoverable at the end of the study, which further reinforces our confidence in its safety and potential," said Dr. Yisheng Lee, Chief Medical Officer of Foresee. "We are delighted to present the preliminary data that underscores the unique product profile of linvemastat, Foresee's second oral MMP-12 inhibitor in clinical development, and potentially the best-in-class profile in view of its superior potency and pharmacokinetic properties. The data and related PK modeling from the first-in-human study in healthy volunteers support our evaluation of different dosing intervals for daily dose for 16 weeks in our potential upcoming Phase 2 clinical trials," said Dr. Wenjin Yang, Chief Scientific Officer of Foresee. "Linvemastat holds great therapeutic potential as a potentially disease-modifying oral therapy in severe asthma, chronic obstructive pulmonary disease (COPD), and inflammatory bowel diseases (IBD) based on the role of MMP-12 in modulation of immune pathways and fibrosis in human respiratory diseases and IBD, where there remains significant unmet medical needs. We aim to improve patient outcomes in the upcoming Phase 2 studies in both asthma and IBD, with initiation planned in 2025," said Bassem Elmankabadi, M.D. Senior Vice President of Clinical Development of Foresee. "Our unwavering efforts underscore Foresee's commitment to pioneering new respiratory and IBD treatments with new mechanisms to target difficult to treat aspects of the diseases. We are excited about the favorable safety, tolerability, and PK profile of linvemastat, and optimistic about the promise of linvemastat, a unique pipeline-in-a-drug opportunity with the potential to capture multibillion US dollar markets as it becomes an anchor product across the immune-fibrotic disease segment and beyond," said Dr. Ben Chien, CEO and Chairman of Foresee. About Linvemastat ( FP-020 ) and MMP-12 Linvemastat (FP-020) is a highly potent and selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. Linvemastat (FP-020) is the new-generation MMP-12 inhibitor developed by Foresee following aderamastat (FP-025). It exhibits excellent pharmaceutical properties, with greater potency and similarly high selectivity compared to aderamastat (FP-025). Linvemastat (FP-020) has shown a favorable efficacy profile in multiple animal models of respiratory diseases and IBD. MMP-12 plays a role in asthma pathophysiology and is associated with disease severity. A Phase 2 allergen challenge asthma proof-of-concept study in aderamastat (FP-025) has been successfully 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 as well as correlative human expression data demonstrating a potential role of MMP-12 in disease severity and treatment responses in asthma, COPD, sarcoidosis, and IBD. MMP-12 is a key immune-fibrotic modulator secreted by macrophages and a key regulator of macrophage, neutrophil, and lung epithelial cell biology and is becoming 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 in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) 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, Taiwan and Israel 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 Casppian Phase 3 clinical study, is ongoing. Another indication of CAMCEVI® 42 mg, premenopausal breast cancer, the Phase 3 clinical trial in China is ongoing as well. Aderamastat (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 had positive outcomes, with future development in rare immune-fibrotic diseases. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, for which a Phase 1 study in healthy volunteers has been successfully completed, with development targeted in severe asthma, COPD and IBD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is ongoing, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the first quarter of 2025. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. SOURCE Foresee Pharmaceuticals Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED