#Taiwan #Taipei #Foresee Pharmaceuticals #Casppian trial #leuprolide mesylate

Foresee Pharmaceuticals Achieves Enrollment Milestone in Phase 3 Casppian Trial

Foresee Pharmaceuticals, based in Taiwan, has announced a groundbreaking achievement in the medical field by completing the enrollment phase of its Phase 3 Casppian trial. This pivotal trial focuses on Central Precocious Puberty (CPP), a condition where children undergo premature sexual development, affecting their physical and emotional well-being.

Understanding the Casppian Trial

The Casppian trial is an open-label, multicenter study assessing the efficacy, safety, and pharmacokinetics of leuprolide mesylate (FP-001) in a controlled-release formulation. The primary objective of the trial is to measure the percentage of patients achieving serum luteinizing hormone (LH) concentrations of less than 4 mIU/mL after a Gonadotropin-releasing hormone (GnRH) agonist stimulation test at the 24-week mark. In the context of this study, leuprolide will be considered effective if at least 80% of participants demonstrate the desired LH suppression.

The Significance of Gonadotropin-releasing Hormone Agonists

Leuprolide belongs to a class of medication known as GnRH agonists, which are widely regarded as the standard treatment for CPP. These medications help regulate hormone levels in children suffering from conditions that lead to the early onset of puberty. It is estimated that about one in every 5,000 to 10,000 children is affected by this condition, with a notably higher prevalence among females.

Statements from Company Executives

Yisheng Lee, M.D., Chief Medical Officer at Foresee Pharmaceuticals, highlighted the critical nature of reaching complete enrollment, asserting that this is an essential step towards fulfilling a considerable health need among children with CPP. Dr. Lee expressed the company's commitment to evaluating the potential of leuprolide mesylate therapy to improve the lives of affected children and their families.

Bassem Elmankabadi, M.D., Senior Vice President of Clinical Development, commended the collective effort of the clinical development team, investigators, and patients in achieving the recruitment milestone. He underscored the company’s pledge to conduct the trial following the strictest safety and quality standards, ensuring reliable data will be obtained for regulatory submission.

Commitment to Pediatric Endocrinology

The company’s CEO, Dr. Ben Chien, Ph.D., reinforced how this milestone demonstrates their commitment to researching innovative therapies tailored for pediatric endocrine disorders. This advancement signifies progress in Foresee’s pipeline and affirms its dedication to investors and future patients alike.

Background on Central Precocious Puberty

Gonadotropin-dependent CPP can disrupt a child’s growth trajectory and lead to psychological, emotional, and social challenges, such as anxiety and decreased self-esteem. Children may begin showing signs of puberty as early as age two and continue until approximately age nine. The treatment aims to mitigate these risks, helping children grow normally and maintain a positive quality of life.

Future Directions and Anticipated Results

As Foresee Pharmaceuticals awaits topline results from the trial, expected by the end of 2025, the company plans to submit a comprehensive New Drug Application (NDA) following the successful outcomes by mid-2026. Their robust pipeline also features other investigational therapies aimed at rare conditions with unmet medical needs, further solidifying its reputation in the biopharmaceutical sector.

In conclusion, Foresee Pharmaceuticals is not only pushing the boundaries in treating CPP but also working diligently to enhance overall outcomes for children experiencing premature sexual development. The successful completion of the Casppian trial enrollment marks a significant achievement for all involved, paving the way for future advancements in treating pediatric endocrine disorders.