Foresee Pharmaceuticals is set to continue patient enrolment for the Casppian study, a Phase III trial evaluating the efficacy of its leuprolide (FP-001) injectable emulsion in treating central precocious puberty (CPP).
The decision comes after the independent Data and Safety Monitoring Board (DSMB) recommended the continuation of the registration study with a slight protocol amendment.
CCP is a condition where children, between two and nine years old, experience early sexual development due to the premature activation of their hypothalamus-pituitary-gland-gonadal axis.
The DSMB found no safety concerns with the use of FP-001 in paediatric CPP patients and recommended proceeding with patient enrolment as planned.
The open-label, multi-centre, multinational Casppian clinical trial aims to evaluate the 42mg-controlled release formulation of FP-001 in patients with CPP.
Foresee Pharmaceuticals clinical development senior vice-president Bassem Elmankabadi said: “We are pleased to receive the positive recommendation from the DSMB to continue our clinical trial.
“Ensuring the safety of the children participating in our trial is paramount and we continue to be dedicated to maintaining the highest standards of safety and ethical conduct throughout this clinical trial. The top-line results from this trial are anticipated in 2025.”
Foresee’s Leuprolide injectable emulsion, 42mg (marketed under the brand name CAMCEVI), is currently approved for treating advanced prostate cancer in adults and has shown significant treatment effects.
Foresee Pharmaceuticals chairman and CEO Dr Ben Chien said: “Foresee's leuprolide 42mg formulation (FP-001) dosed subcutaneously every six months, has the potential to become the only ready-to-use Leuprolide six-month long-acting injection on the market, providing benefit to stakeholders in the CPP community.
“We look forward to establishing commercial partnership soon for the potential future commercialisation of FP-001, in CPP indication.”
Last year, Foresee dosed the first patient in the Casppian Phase III registration study to assess the efficacy, safety, and pharmacokinetics of FP-001 42mg-controlled release.
