Foresee Pharmaceuticals Announces First Patient Dosed in the Casppian, Phase 3 Clinical Trial of Leuprolide (FP-001) injectable emulsion, 42 mg for the treatment of Central Precocious Puberty patients.

• 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.

"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. www.foreseepharma.com

SOURCE Foresee Pharmaceuticals Co., Ltd.