Foresee Pharmaceuticals Unveils New Progress in Long-Acting Injectable Technologies

TAIPEI, Aug. 9, 2024 – Foresee Pharmaceuticals has recently unveiled several significant advancements in its Stabilized Injectable Formulation (SIF) long-acting injectable (LAI) technologies. The company disclosed four innovative and proprietary SIF LAI delivery systems: SIF-ADAGIOTM, SIF-LEGATOTM, SIF-DUOTM, and SIF-MEZZOTM.

Foresee's initial success with its SIF-derived product, CAMCEVI®, has propelled the company to further expand its SIF technology platform. This has solidified Foresee's leadership in the LAI sector by demonstrating a deep understanding of the complexities involved in LAI development. The SIF platform’s adaptability and flexibility are unparalleled, allowing Foresee to push the boundaries of innovation in the LAI field.

The company’s commercial product, CAMCEVI®, utilizes the SIF-ADAGIOTM delivery system, which is based on biodegradable polymers. This system is also being applied to other products, such as FP-014, which is a ready-to-use, subcutaneous triptorelin LAI available in 3 and 6-month formulations.

The SIF-LEGATOTM system represents a novel combination lipid-based delivery method, offering the unique advantage of high drug loading. This flexibility makes it suitable for various drug substances and product profiles. Currently, this system is being used to develop several early-stage neurology products.

Foresee has developed the SIF-DUOTM, a solution-based system, for its early psychiatry LAI programs. This delivery system is particularly beneficial for these applications. Meanwhile, the SIF-MEZZOTM system is still in the development and optimization phase.

Dr. Ben Chien, Chairman and CEO of Foresee, expressed his enthusiasm about these advancements, stating, “We are committed to advancing our product portfolio across both SIF and NCE programs. We are making significant progress in enhancing the technological and intellectual property foundations of our company. Staying ahead in the complex LAI products and technologies sector remains a key part of our mission.”

Dr. Yuhua Li, Chief Technology Officer of Foresee, added, “We are excited about the potential of these emerging SIF delivery systems. Our experience with the SIF-ADAGIOTM system and the commercial success of CAMCEVI® have proven the value of our technology and expertise. We are now ready to demonstrate the commercial potential of our new delivery systems.”

Foresee Pharmaceuticals is a biopharmaceutical company based in Taiwan and the US, listed on the Taipei Exchange. The company focuses its R&D efforts on two main areas: SIF long-acting injectable technology targeting specialty markets and transformative preclinical and clinical first-in-class NCE programs for rare and severe diseases with high unmet needs. 

Foresee’s product portfolio includes late and early-stage programs. CAMCEVI® 42 mg, for the treatment of advanced prostate cancer, has received approval in the U.S., Canada, the EU, Taiwan, and Israel, and was launched in the U.S. in April 2022. Additionally, regulatory submissions are being prepared for CAMCEVI® 21 mg. Another indication for CAMCEVI® 42 mg, central precocious puberty (CPP), is currently under investigation in the Casppian Phase 3 clinical study.

FP-025, an oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has completed a Phase 2 proof-of-concept study in allergic asthmatic patients with positive outcomes. Future development will focus on rare immune-fibrotic diseases. FP-020, another oral MMP-12 inhibitor, is in Phase 1 development targeting severe asthma, COPD, and IBD.

FP-045, an oral small molecule allosteric activator of ALDH2, is in the initiation phase of the FuschiA Phase 1b/2 study for Fanconi Anemia, and a Phase 2 study for pulmonary hypertension-interstitial lung disease (PH-ILD) is planned for the fourth quarter of 2024. Building on promising ALDH2 biology and translational data, a new compound from this series is being selected for development in metabolic syndrome, healthy weight loss, and the broader cardiovascular-renal-metabolic space.

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