Foresee Pharmaceuticals Submits NDA to FDA for 3-Month CAMCEVI for Advanced Prostate Cancer

Foresee Pharmaceuticals Co., Ltd. (TPEx: 6576), a biopharmaceutical company with operations in Taiwan and the United States, announced the submission of a New Drug Application (NDA) for a 3-month version of CAMCEVI, a ready-to-use depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA). This new version aims to treat advanced prostate cancer palliatively.

The NDA is backed by a successful Phase 3 clinical trial involving 144 patients with advanced prostate cancer. The trial demonstrated the effectiveness, safety, and tolerability of the 3-month leuprolide mesylate injection, with 97.9% of participants reaching the primary efficacy endpoint.

Dr. Ben Chien, Founder and Chairman of Foresee Pharmaceuticals, expressed enthusiasm about the submission. He noted that following the successful launch of the 6-month CAMCEVI depot formulation in 2022, the 3-month version's submission is a significant step in broadening treatment options for advanced prostate cancer. The company anticipates FDA approval in 2025 and plans to commercially launch the product in 2026, highlighting its convenient, ready-to-use profile.

Foresee Pharmaceuticals is a listed entity on the Taipei Exchange and focuses its research and development in two primary areas: the Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technology and the development of first-in-class NCE programs targeting rare and severe diseases with unmet needs.

The company's product portfolio features both late and early-stage programs. The 6-month CAMCEVI depot formulation for advanced prostate cancer is already approved in the U.S., Canada, EU, Taiwan, and Israel, with the U.S. launch occurring in April 2022. While the 3-month version's U.S. regulatory submission is complete, the EU submission is still being prepared. For another indication, central precocious puberty (CPP), the Casppian Phase 3 clinical study of the 6-month CAMCEVI depot formulation is in progress. Additionally, the phase 3 trial for premenopausal breast cancer is ongoing in China.

Other products in Foresee's portfolio include Aderamastat (FP-025), an oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, which has shown positive results in a Phase 2 proof-of-concept study on allergic asthma. The company plans to extend its development into rare immune-fibrotic diseases. Linvemastat (FP-020), another MMP-12 inhibitor, has successfully completed a Phase 1 study in healthy volunteers, with further development aimed at severe asthma, COPD, and IBD. Mirivadelgat (FP-045), an oral small molecule allosteric activator of ALDH2, is currently being investigated in the FuschiA Phase 1b/2 study for Fanconi Anemia, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is set to begin in the first quarter of 2025.

Foresee builds on the promising biology of ALDH2 and translational data from various ALDH2 activators, selecting a new candidate for development targeting metabolic syndrome, healthy weight loss, and the cardiovascular-renal-metabolic space.

This announcement underscores Foresee Pharmaceuticals' commitment to expanding its treatment portfolio and addressing significant unmet medical needs in various therapeutic areas.