Foresee Pharmaceuticals gains third DSMB endorsement for Casppian Phase 3 study, strengthening confidence in long-acting Leuprolide formulation

The latest safety review supports Foresee Pharmaceuticals’ continued progress in developing a long-acting leuprolide injectable emulsion for pediatric central precocious puberty treatment.

Foresee Pharmaceuticals has secured a third consecutive positive safety recommendation from the independent Data and Safety Monitoring Board (DSMB) for its Casppian Phase 3 trial. This milestone further validates the safety of leuprolide (FP-001) injectable emulsion for pediatric patients with central precocious puberty (CPP). The DSMB has advised that patient enrollment should continue without modifications, reinforcing confidence in the drug’s potential as a long-term treatment option.

Casppian Phase 3 Trial Advances with Strong Safety Profile

The Casppian Phase 3 study is a multinational, open-label clinical trial assessing the efficacy, safety, and pharmacokinetics of a long-acting leuprolide injectable emulsion administered every six months. The treatment is designed to regulate the hormonal imbalance responsible for premature puberty onset in children. The latest DSMB review, conducted as enrollment reaches approximately 75%, underscores the therapy’s consistent safety profile and the absence of any significant adverse effects.

Leuprolide injectable emulsion is already marketed as CAMCEVI® for treating advanced prostate cancer in adult patients. Its application in pediatric endocrinology represents an expansion of Foresee Pharmaceuticals’ drug pipeline, leveraging the same proprietary drug delivery mechanism to provide sustained therapeutic effects. The ability to administer the treatment on a six-month cycle rather than more frequent injections is expected to enhance adherence and improve quality of life for young patients undergoing CPP treatment.

How Long-Acting Leuprolide Formulation Can Transform CPP Treatment

Central precocious puberty is a rare endocrine disorder that triggers early puberty in children, often between two and nine years of age. This premature activation of the hypothalamic-pituitary-gonadal axis results in accelerated bone growth, potentially leading to a shorter adult height, along with psychological and emotional challenges.

The most widely used treatment approach involves gonadotropin-releasing hormone (GnRH) agonists, which work by suppressing premature hormonal activation. Leuprolide injectable emulsion, as a long-acting leuprolide formulation, offers a more convenient alternative by reducing the frequency of required injections while maintaining consistent hormonal suppression.

With the DSMB’s repeated positive assessments, the Casppian study continues to build confidence that this long-acting leuprolide formulation could become a key advancement in pediatric endocrinology. Early efficacy signals indicate that the treatment effectively manages the symptoms of CPP while ensuring a favorable safety profile.

Proprietary Drug Delivery Technology Reinforces Foresee Pharmaceuticals’ Innovation

The development of the long-acting leuprolide formulation is driven by Foresee Pharmaceuticals’ proprietary Stabilized Injectable Formulation (SIF) technology, which enables sustained drug release with a controlled pharmacokinetic profile. The technology has been successfully implemented in the company’s prostate cancer therapy and is now being evaluated for additional indications, including pediatric endocrinology and breast cancer.

Foresee Pharmaceuticals has positioned itself as a leader in long-acting drug delivery, with multiple formulations under development targeting chronic conditions that require consistent therapeutic management. The Casppian Phase 3 trial serves as a critical step toward expanding the reach of this platform technology into new therapeutic areas.

Foresee Pharmaceuticals Expands Regulatory and Commercial Pipeline

Beyond its CPP program, Foresee Pharmaceuticals is actively advancing its portfolio of long-acting injectable therapies. CAMCEVI 42 mg is currently approved for prostate cancer treatment in multiple markets, including the United States, Canada, Europe, Taiwan, Israel, and the United Kingdom. Additional regulatory filings are in progress, with the three-month CAMCEVI formulation under U.S. FDA review, expected to receive a decision by August 2025. A European regulatory submission for the same formulation is also in preparation.

The six-month formulation, currently in the Casppian Phase 3 trial for pediatric CPP, is also being evaluated for potential use in premenopausal breast cancer. Meanwhile, Foresee Pharmaceuticals is developing triptorelin (FP-014) for advanced prostate cancer, with clinical trials planned for three-month and six-month ready-to-use formulations.

The company’s broader drug development pipeline extends beyond hormone therapies, with additional programs targeting inflammatory, fibrotic, and metabolic diseases. Recent advancements include the completion of a Phase 2 study for an MMP-12 inhibitor aimed at treating allergic asthma and ongoing research into applications for pulmonary hypertension and cardiovascular-renal-metabolic disorders.

Casppian Study to Deliver Key Results in 2025

With the latest DSMB recommendation affirming the study’s safety trajectory, Foresee Pharmaceuticals remains on track to complete patient enrollment and deliver top-line results from the Casppian Phase 3 trial in 2025. If successful, the long-acting leuprolide formulation could redefine CPP treatment by offering a safer, more convenient therapeutic option for pediatric patients.

As Foresee Pharmaceuticals continues to expand its long-acting injectable technology into new therapeutic areas, the Casppian study represents a key milestone in the company’s broader vision of developing innovative, patient-centered solutions for endocrine and oncological disorders.