Foresee Pharmaceuticals Receives the Second Positive Recommendation from DSMB to Continue the Casppian Study, a Phase 3 Clinical Trial of Leuprolide (FP-001) Injectable Emulsion for the Treatment of Central Precocious Puberty

• 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, Nov. 15, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces the second 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 without any modification.

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.

"With almost 50% enrollment completed, the second positive DSMB recommendation to continue the Casppian trial without any modification confirms the favorable safety profile of FP-001, 42 mg 6 month long-acting, ready-to-use, subcutaneous injectable treatment in patients with CPP. The differentiated product profile, favorable safety profile in combination with the early indications of efficacy lead us to believe this therapy will become a leading therapy for pediatric patients with CPP. We look forward to continuing to enroll patients and are dedicated to maintaining the highest standards of safety and ethical conduct throughout this clinical trial," said Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development of Foresee.  

"This DSMB recommendation again demonstrates the success of Foresee's pioneering Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology in several disease indications, including children with CPP," said Dr. Yuhua Li, Chief Technology Officer of Foresee.

"The outcome of the second DSMB for the Casppian study is a significant step toward our mission of improving the standard of care and the quality of life of children with CPP," said Dr. Ben Chien, CEO and Chairman of Foresee. "This positive recommendation brings us closer to our goal of delivering safe and effective treatment for children with CPP. Topline results from this trial as anticipated in 2025."           

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 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 or the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan and Israel 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. www.foreseepharma.com 

SOURCE Foresee Pharmaceuticals Co., Ltd.