Foresee Pharmaceuticals Announces Several New Developments Related to its SIF Long-Acting Injectable (LAI) Technologies - Solidifying its Position as a Leader in Complex Long-Acting Injectable Products

TAIPEI, Aug. 9, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced several new developments related to its SIF long-acting injectable (LAI) technologies, namely the disclosure of its four novel and proprietary SIF LAI delivery systems: SIF-ADAGIO^TM, SIF-LEGATO^TM, SIF-DUO^TM, and SIF-MEZZO^TM.

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Building on the tremendous success of its first SIF-derived product CAMCEVI^®, Foresee has been continuously developing and expanding its SIF technology platform as well as its industry dominance and leadership in the area of LAI's, from the technology, intellectual property and product development perspective. In view of the complexity of LAI's, requiring a remarkable depth of know-how, expertise, and experience, very few organizations have developed a LAI technology platform with the level of flexibility and adaptability that can be found in the SIF platform. In fact, Foresee has now developed four distinct SIF LAI delivery systems that will enable even greater flexibility and allow to continue to push the boundaries of innovation in complex LAI products. Foresee will be disclosing more information on these new SIF delivery systems over the upcoming months. Below is a summary:

Foresee's commercial product CAMCEVI^® was developed using its SIF-ADAGIO^TM delivery system, based on biodegradable polymers. Foresee is also applying its SIF-ADAGIO^TM system to other products in the portfolio, namely FP-014, its best-in-class ready-to-use, subcutaneous, 3 and 6-month triptorelin LAI. The SIF-LEGATO^TM system is a novel combination lipid-based system that has the unique advantage of permitting very high drug loading, making it highly adaptable to various drug substances and product profiles. This SIF LAI delivery system is currently being employed for the development of several early neurology products in our portfolio. SIF-DUO^TM is a solution-based system which Foresee is using for the development of some of its early psychiatry LAI programs that benefit from this unique delivery system, while our SIF-MEZZO^TM delivery system remains in development and optimization phase.

"We are pleased to announce these recent developments in our SIF LAI technologies," said Dr. Ben Chien, Foresee's Chairman and CEO. "While we remain very committed to the advancement of our product portfolio across both SIF and NCE programs, we continue to make significant strides in advancing the technology and intellectual property foundations on which we have built our company. A key part of our mission is to remain a leader in complex LAI products and technologies."

"We are very enthusiastic about the promise of these emerging SIF delivery systems. We have proven the value of our technology and expertise through the application of our SIF-ADAGIO^TM system to CAMCEVI^®, a best-in-class product growing successfully in the market, now we are ready to embark in the second phase of our mission by demonstrating the commercial potential of the new delivery systems," said Dr. Yuhua Li, Foresee's Chief Technology Officer.

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 in two key areas, namely its unique Stabilized Injectable Formulation (SIF) long-acting injectable 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 and Israel and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI^® 21 mg. For the second indication of CAMCEVI^® 42 mg, central precocious puberty (CPP), the Casppian Phase 3 clinical study, has been initiated. FP-025, a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, has been investigated in a Phase 2 proof-of-concept study in allergic asthmatic patients. The study has been completed with positive outcomes, with future development in rare immune-fibrotic diseases. FP-020, a follow-on oral MMP-12 inhibitor currently in Phase 1, with development targeted in severe asthma, COPD and IBD. FP-045 is a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which the FuschiA Phase 1b/2 Fanconi Anemia study is currently being initiated, and the Phase 2 WINDWARD study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning with targeted initiation in the fourth quarter of 2024. Building on the compelling biology of ALDH2, and translational data from several Foresee ALDH2 activators, a follow-on candidate from a new series of compounds is being selected for development in metabolic syndrome/healthy weight loss and the broader cardiovascular-renal-metabolic space. www.foreseepharma.com

SOURCE Foresee Pharmaceuticals Co., Ltd.