DSMB Endorses Continuation of Casppian Phase 3 Trial for Leuprolide Emulsion in Central Precocious Puberty

Foresee Pharmaceuticals recently received a favorable safety review from an independent Data and Safety Monitoring Board (DSMB) concerning its Phase 3 Casppian study. This clinical trial is focused on examining the efficacy, safety, and pharmacokinetics of a 42 mg controlled-release formulation of Leuprolide (FP-001) for treating central precocious puberty (CPP) in pediatric patients. Currently marketed as CAMCEVI® for advanced prostate cancer, FP-001 has shown promising results in adult patients and is now being evaluated for its potential benefits in younger populations affected by CPP.

Foresee Pharmaceuticals plans to continue the Casppian study with some protocol adjustments recommended by the DSMB. The DSMB's recommendations come without any noted safety concerns regarding the use of Leuprolide in the pediatric CPP population. The top-line results from this ongoing trial are anticipated to be available by 2025.

Dr. Bassem Elmankabadi, Senior Vice President of Clinical Development at Foresee, emphasized the importance of ensuring the safety of the children participating in the trial. He expressed satisfaction with the DSMB's positive recommendation, reaffirming Foresee's commitment to maintaining high standards of safety and ethical conduct in their clinical trials. Dr. Ben Chien, the Chairman and CEO of Foresee, highlighted the potential of this 42 mg formulation of Leuprolide. Administered subcutaneously every six months, this treatment could become a significant advancement for the CPP community, aiming to offer a ready-to-use, long-acting option.

Central precocious puberty (CPP) is a condition caused by the premature activation of the hypothalamus-pituitary-gonadal axis, leading to early sexual development in children. This premature puberty can result in short stature in adulthood and various psychosocial challenges, including lower self-esteem, anxiety, and depression, which can affect the overall quality of life. CPP is relatively rare, affecting about 1 in 5,000 to 10,000 children, and is more common in females. Most CPP cases are idiopathic and are primarily treated using GnRH agonists, such as Leuprolide.

Foresee Pharmaceuticals is a biopharmaceutical firm with operations in Taiwan and the United States. It is listed on the Taipei Exchange and focuses its R&D on long-acting injectable technologies and first-in-class new chemical entities targeting rare and severe diseases with significant unmet needs. The company's portfolio includes both late and early-stage programs. Notably, CAMCEVI® 42 mg is approved for prostate cancer treatment in multiple regions including the U.S., Canada, EU, and Taiwan. Foresee is also preparing regulatory submissions for a 21 mg formulation and is advancing other clinical programs targeting conditions like severe asthma, COPD, Fanconi Anemia, and pulmonary hypertension-interstitial lung disease.