Triptorelin Pamoate

TAIPEI, Dec. 4, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announces that it has successfully completed an underwritten public offering of 18,000,000 shares of its common stock to the public at a price of NT$76 per share. The aggregate gross proceeds to Foresee from the offering were NT$1,368 million (or US$42.1 million at FX=32.5). The proceeds of the public offering will be used for general corporate purposes, including FP-014 (triptorelin), a ready-to-use long-acting injectable, administered either every three months or six months, in two Phase 3 clinical trials for advanced prostate cancer, respectively; FP-020 (linvemastat), an MMP-12 inhibitor, in two Phase 2 studies for both asthma and inflammatory bowel disease (IBD), and FP-045 (mirivadelgat), an ALDH2 activator, in a Phase 2 clinical trial for pulmonary hypertension associated with interstitial lung disease (PH-ILD). "We are pleased to announce the successful completion of the public offering. I would like to express my gratitude once again for shareholders' full support and trust in us." said Dr. Ben Chien, Founder and Chairman of Foresee. "This funding will enable us to accelerate our R&D progress and create more value for our shareholders." 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 (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 or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was 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 LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study, is ongoing. Another indication of CAMCEVI 6-month LAI 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

Debiopharm’s expertise in extended-release formulations could lighten the burden of treatment for children with Central Precocious Puberty (CPP) and their families by reducing injection frequency to once a year Lausanne, Switzerland – September 9th, 2024 – Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to develop innovative therapies and to improve patient quality of life, today announced the dosing of the first sentinel patients in its open-label, single-arm, multi-center Phase III study, NCT06129539 ‘A Study to Assess the Efficacy, Safety and Pharmacokinetics of Debio 4326 in Pediatric Participants Receiving Gonadotropin-Releasing Hormone Agonist Therapy for Central Precocious Puberty (LIBELULA)’. Triptorelin is an established treatment for CPP as a 1-, 3- and 6-month formulation. This new phase III study evaluating the novel 12-month triptorelin formulation is being carried out in North and South America. In pursuit of developing safe, effective, and convenient treatment options for patients, Debiopharm, is applying its expertise in extended-release formulations to achieve the first yearly injectable Gonadotropin-Releasing Hormone agonist (GnRHa). Reducing treatment burden while preserving triptorelin’s well-known efficacy and safety are key elements that Debiopharm is eager to assess through this study. “It is always disheartening to see such young children burdened by the effects of central precocious puberty and the lifelong complications it may cause. We are thankful that treatments like triptorelin are already on the market, and that companies like Debiopharm continue to invest in lightening the patient care burden with formulations that reduce injection frequency.” expressed Prof. Fernando Cassorla, Principal Investigator, Pediatrics Department at the Hospital San Borja Arriarán in Santiago, Chile. “As patients are at the center of all we do, we recognize that convenience matters. Reducing injection frequency to once a year can lower the burden for CPP patients and their caretakers by reducing children’s stress and improving overall compliance. We are enthusiastic about the first patients enrolled in this phase III trial that can bring both medical and practical advancements.” expressed Bertrand Ducrey, CEO of Debiopharm. About Central Precocious Puberty Central precocious puberty (CPP) occurs at an unusually early age, before 8 years of age in girls and before 9 years of age in boys [1-2]. It is characterized by a premature development of secondary sexual characteristics (e.g. breasts for girls and enlarged testicles for boys), accelerated growth, and bone maturation leading to reduced adult height. CPP is triggered by the early release of the gonadotropin-releasing hormone in the brain and premature activation of the hypothalamic-pituitary-gonadal axis. This early activation can be due to specific genetic alterations, central nervous system lesions, and social stressors but frequently has no identified etiology [3]. The approximative prevalence of CPP is 1 in 5,000-10,000 among Caucasians, more frequent in girls than in boys globally [4]. Precocious puberty may be associated with psychosocial difficulties and carries potential negative implications for long-term health including increased risk of metabolic complications, such as type 2 diabetes, weight gain, obesity, cardiovascular disease, as well as depression, and even premature death [5-10]. Early puberty has also been associated with an increased risk of breast cancer in women. In men, it may increase the risk of prostate cancer [11-13]. Since the early 1980s, Gonadotropin-Releasing Hormone agonists (GnRHa) such as triptorelin have been the standard of care for the treatment of CPP [14-16]. Treatment aims to preserve adult height and prevent social and psychological difficulties and the various potential consequences on long-term health. Currently, there are several different extended-release GnRHa formulations ranging from monthly injections to subcutaneous implants for annual use [17]. While the latter may have a longer duration of action, it requires yearly surgical positioning. About Debio 4326 Debio 4326 is a unique injectable, biodegradable 12-month extended-release formulation of triptorelin designed to further reduce the frequency of injections and burden of administrations, particularly considering its intended use in a pediatric population. Based on favorable efficacy and safety data with the different triptorelin 1-, 3- and 6-month formulations, Debio 4326 aims to preserve efficacy while providing increased comfort, ensure long-term compliance, and reduce stress for children and their parents. Debiopharm’s commitment to patients Debiopharm aims to develop innovative therapies that target high unmet medical needs primarily in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then hand stewardship to large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com We are on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews Sources [1] Latronico AC, et al. Lancet Diabetes Endocrinol. 2016;4(3):265–274. [PubMed: 26852255] [2] Sanctis V, et al. Acta biomedica: Atenei Parmensis. 2019 90 (3): 345-359. [3] Maione L, et al. Clin Endocrinol (Oxf). 2021 Oct;95(4):542-555. doi: 10.1111/cen.14475. Epub 2021 Apr 20. PMID: 33797780; PMCID: PMC8586890 [4] National Organization for Rare Disorders (NORD) 2022 [5] Day FR, et al. 2015. Sci Rep, 5: 11208. [6] Elks CE, et al. 2013. Diabetes Care, 36 (11): 3526-34. [7] Prentice P, and Viner RM. 2013. Int J Obes (Lond), 37 (8): 1036-43 [8] Ong KK, et al. 2012. J Clin Endocrinol Metab, 97 (8): 2844-52. [9] Hamlat EJ, et al. 2014. J Abnorm Child Psychol, 42 (4): 527-38. [10] Charalampopoulos D, et al. 2014. Am J Epidemiol, 180 (1): 29-40. [11] Day FR, et al. 2017. Nat Genet, 49 (6): 834-41. [12] Bonilla C, et al. 2016. BMC Med, 14: 66. [13] Bräuner EV, et al. 2020. JAMA Netw Open, 3 (10): e2015665 [14] Carel JC, et al. 2009. Pediatrics, 123 (4): e752-62. [15] Bertelloni S, et al. 2015. Horm Res Paediatr, 84 (6): 396-400. [16] Bangalore Krishna K, et al. 2019. Horm Res Paediatr, 91 (6): 357-72. [17] Aguirre RS, Eugster EA. Best Pract Res Clin Endocrinol Metab. 2018;32(4):343–354.