Foresee Pharmaceuticals has shown that a long-acting version of its injectable prostate cancer med Camcevi can help patients with central precocious puberty (CPP), potentially opening the door to a new treatment option for children with the premature puberty condition.
The company tested a 42 mg dose of its GnRH agonist leuprolide mesylate, coded as FP-001, given every six months in its phase 3 Casppian study to gauge how the drug affects serum luteinizing hormone (LH) concentrations. After a GnRHa stimulation test at week 24 of the study, 94% of evaluated patients experienced serum LH suppression to more than 4 mIU/mL at 60 minutes, a statistically significant marker that exceeded the pre-specified criteria for success, Foresee said in a Dec. 24 press release.
“Meeting this rigorous primary endpoint with such a high threshold of 94% is a significant milestone,” the company's SVP of clinical development, Bassem Elmankabadi, M.D., said in the release. “It underscores the potential of FP-001 to offer a meaningful new treatment option, potentially improving convenience and adherence of children with CPP."
With the “robust efficacy data” in hand, Foresee is confident in its long-acting offering as a “potential best-in-class therapy,” CEO and founder Ben Chien, Ph.D., added in the release. The Taiwan-based company will present the full study results at an upcoming scientific conference and plans to engage with global regulatory authorities to discuss submitting a new drug application by mid-year.
Camcevi, in its 42 mg, six-month dosing formulation, was first approved in 2021 as a treatment for advanced prostate cancer, which Accord BioPharma markets in the U.S. The drug was made using Foresee’s stabilized injectable formulation (SIF) technology, allowing for ready-to-use injectables with tailor-made therapeutic durations.
In August, the FDA approved a 21-mg dose version of Camcevi in its advanced prostate cancer indication, this one with an every-three-months dosing schedule. At the time, Chien called the nod a “key step in our efforts to build Foresee as a profitable and growing business.”
The company has long been eyeing the drug’s potential in CPP, a rare condition marked by premature activation of the pituitary-gonadal axis, prompting early puberty onset.
Other GnRH meds — like AbbVie's Lupron, which also contains leuprolide — have been able to carve out an edge in both CPP and prostate cancer. GnRH agonists like leuprolide are the typical standard-of-care treatment for the disease, which, if left untreated, is linked to psychosocial challenges and can negatively impact growth.
Foresee’s ambition in CPP is bolstered by three positive recommendations from the trial's independent Data and Safety Monitoring Board. The most recent update in February was a recommendation that the company continue the trial without modification, following the April 2024 board suggestion to use a “minor” amended protocol.
FP-001’s safety signals in the Casppian study were “consistent with the established class profile of GnRH agonists,” with the most common adverse events typically mild to moderate in severity, chief medical officer Yisheng Lee, M.D., commented in the recent release.
The company is also studying long-acting Camcevi in a phase 3 trial in patients with premenopausal breast cancer in China. Elsewhere, Foresee is testing two oral MMP-12 inhibitors in immune-fibrotic diseases.