- A multicenter, multinational Phase 3 Casppian study will evaluate the efficacy and safety of leuprolide mesylate (FP-001) 42 mg controlled-release in patients with CPP.
- Gonadotropin-releasing hormone (GnRH) agonists, including leuprolide, are the most widely used treatment for CPP.
- Topline results from this pivotal trial are expected by the end of 2025.
- Based on the successful outcomes of the study completion by mid-2026, Foresee plans to submit a comprehensive New Drug Application (NDA) package to regulatory authorities by Q3 2026.
TAIPEI, June 17, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces reaching a significant milestone, the complete enrollment of its Phase 3 Casppian trial for patients with Central Precocious Puberty (CPP). The Casppian Phase 3 study is an open-label, multicenter clinical trial evaluating 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. 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.
- "Reaching full enrollment in this pivotal Phase 3 trial is a crucial step toward addressing a significant unmet need in central precocious puberty. We are deeply committed to rigorously evaluating Leuprolide mesylate therapy's potential to make a meaningful difference for affected children with CPP and their families." Stated Yisheng Lee, M.D. Chief Medical Officer
- The efficient completion of enrollment in the casppian Phase 3 study reflects the dedication of our clinical development team, investigators, and participating patients and their families. We are unwavering in our commitment to executing the trial with the highest safety and quality standards to generate robust data for regulatory submission." Stated Bassem Elmankabadi, M.D. Senior Vice President of Clinical Development
- As we fully enroll our Casppian Phase 3 trial, we reaffirm our commitment to advancing innovative therapies for pediatric endocrine disorders. This milestone not only marks significant progress for our pipeline but also demonstrates our dedication to our investors and potential future patients, as stated by Dr. Ben Chien, PhD., our Chairman and CEO.
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 (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 and accepted for review with a PDUFA date of August 29, 2025, 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. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. 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, has completed a Phase 1 study in healthy volunteers, with development targeted at severe asthma and, COPD. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients was initiated in the second 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 the cardiovascular-renal-metabolic space. www.foreseepharma.com
SOURCE Foresee Pharmaceuticals Co., Ltd.
