Foresee Pharmaceuticals Receives the Fourth Positive Recommendation from the DSMB to Continue the Casppian Ph3 Study, for Central Precocious Puberty (CPP)
- The independent Data and Safety Monitoring Board (DSMB) recommended the continuation of the study as planned.
- The Casppian study design included periodic evaluations and long-term safety monitoring for up to a total of 12 months following the first injection.
- There has been no safety concern with the use of leuprolide (FP-001) injectable Emulsion in pediatric CPP patients.
- The Casppian Phase 3 Study Met Primary Efficacy Endpoint, Demonstrating Robust LH Suppression with 6-Month Dosing Interval of leuprolide mesylate.
TAIPEI, Feb. 4, 2026 /PRNewswire/ — Foresee Pharmaceuticals (TPEx: 6576), (“Foresee”) today announces the fourth positive safety review by the independent Data and Safety Monitoring Board for its Casppian Phase 3 registration study. The DSMB recommended that Foresee Pharmaceuticals continue the trial as planned without any modification. The Casppian Phase 3 study is an open-label, multicenter, multinational clinical trial evaluating the efficacy, safety, and pharmacokinetics of leuprolide (FP-001) 42 mg controlled-release in patients with central (Gonadotropin-Dependent) precocious puberty (CPP).
Foresee’s leuprolide injectable emulsion, 42 mg (marketed under the brand name CAMCEVI®), is currently approved for the treatment of adult patients with advanced prostate cancer and has demonstrated positive efficacy and safety results with statistically significant treatment effects in adult male patients with advanced prostate cancer.
“The unanimous safety endorsement from the independent board, following full enrollment in our Casppian Ph3 trial, is a powerful testament to the potential of our six-month treatment for children with CPP. Meeting the study’s primary endpoint is a definitive signal that we are on the cusp of a potential therapy, bringing us closer to a future medicine where managing this condition is simpler and more effective for young patients with CPP,” Stated Bassem Elmankabadi, M.D. Senior Vice President, Clinical Development
“This recommendation is more than a milestone; it validates our unwavering commitment to possible alternative treatments that are both powerfully effective and well tolerated. It reinforces the promise of long-acting GnRH to fundamentally improve the journey for CPP patients. We move forward with this pivotal study, guided by our core principles of scientific rigor, patient safety, and ethical integrity,” Stated Yisheng Lee, M.D. Chief Medical Officer
“With this critical DSMB affirmation, we are charging ahead in our mission to add to the existing therapies of care for children with CPP. This momentum fuels our drive as we prepare for our next regulatory step, bringing a groundbreaking new treatment option closer to reality. Our deepest gratitude goes to the courageous patients and families in our Casppian trial. Their partnership is the very heart of this progress, and together, we are raising the standard of hope.” Stated Dr. Ben Chien, PhD. The chairman and CEO.
About Central Precocious Puberty (CPP)
Central Precocious Puberty is a condition characterized by premature activation of the pituitary-gonadal axis, leading to early puberty. If left untreated, CPP can result in accelerated bone maturation and reduced final adult height, as well as significant psychosocial challenges for affected children. The current standard of care involves treatment with GnRH agonists to halt pubertal progression.
About FP-001 42 mg
FP-001 42 mg is an investigational, sustained-release formulation of a GnRH agonist being developed for the treatment of CPP. It is designed to provide continuous suppression of gonadotropin secretion for 6 months following a single intramuscular injection, offering a less-frequent dosing alternative to existing therapies.
About Foresee Pharmaceuticals Co., Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (TPEx: 6576). Foresee’s R&D efforts are focused on two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology with derived drug products targeting specialty markets and secondly, its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs.
Foresee’s product portfolio includes late and early-stage programs. CAMCEVI 42 mg, for the treatment of advanced prostate cancer, is now approved in the U.S., Canada, EU, Taiwan, Israel, and the UK and was launched in the U.S. in April 2022. Additionally, CAMCEVI ETM was approved by the U.S. FDA on August 25, 2025, while the EU regulatory review for the 3-month version of CAMCEVI is still ongoing. For the second indication of CAMCEVI 6-month LAI formulation, central precocious puberty (CPP), the Casppian Phase 3 clinical study is ongoing. CAMCEVI 6-month LAI formulation is also being developed in a Phase 3 clinical trial in premenopausal breast cancer in China in collaboration with its partner. Aderamastat (FP-025), a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, successfully completed a Phase 2 proof-of-concept study in allergic asthmatic patients. Future development of aderamastat will be in rare immune-fibrotic diseases, including cardiac sarcoidosis. Linvemastat (FP-020), a follow-on oral MMP-12 inhibitor, has completed a Phase 1 study in healthy volunteers, with development targeted in severe asthma and COPD. In January 2026, Foresee has licensed exclusive global rights related to its MMP-12 inhibitor programs to Primevera Therapeutics, LLC. Mirivadelgat (FP-045) is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients was initiated in the second quarter of 2025. www.foreseepharma.com
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SOURCE Foresee Pharmaceuticals Co., Ltd.
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