Foresee Pharmaceuticals Selected for Late-Breaking Oral Presentation on its Aderamastat Phase 2 Study Results at the European Respiratory Society (ERS) International Congress 2023

TAIPEI, July 25, 2023 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announced today that the company has been selected for a late-breaking oral presentation on the positive primary outcomes of its aderamastat (FP-025) Phase 2 proof-of-concept allergic asthma study at the European Respiratory Society (ERS) International Congress 2023 taking place in Milan, Italy from September 9-13, 2023.

The oral presentation entitled: "Effect of MMP-12 inhibitor, aderamastat (FP-025), on allergen-induced late response in asthmatic subjects" is the result of a collaboration with clinical experts in the area of asthma and pulmonology in the Netherlands, and focuses on the primary results from the assessment of the efficacy of multiple oral doses of aderamastat in HDM-allergic asthma patients.

Oral Presentation Session: Pathways and mechanisms governing the pathogenesis of asthma and chronic obstructive pulmonary disease

Monday September 11, 2023

Time: 9:30 am CET

Location: Allianz MiCo, Milan

Room: Brown 1+2

(https://www.ersnet.org/wp-content/uploads/2023/07/PROGRAMME-2023-0507.pdf)

"We are very excited to have the opportunity to present promising data related to the previously announced aderamastat topline Phase 2 proof-of-concept study. The data strongly support the role of MMP-12 in key inflammatory pathways that contribute to asthma and other lung diseases," said Dr. Yisheng Lee, Chief Medical Officer at Foresee. "With this Phase 2 study, our objective was to demonstrate that the inhibition of MMP-12 in humans was in line with the MMP-12 single-nucleotide polymorphism (SNP) data, human expression data, and animal pharmacology models. We could not be more confident with the role and importance of MMP-12 in immune-fibrotic diseases, particularly in the lung," added Dr. Lee.

"With this recent positive aderamastat Phase 2 study, we are excited to shine a light on a novel therapeutic mechanism and are working diligently to build a broad first-in-class/best-in-class franchise leveraging aderamastat, our additional MMP-12 inhibitors, including FP-020, across several therapeutic areas," said Dr. Ben Chien, Chairman and CEO at Foresee.

The presentation will be available on the Foresee website after the conference.

About Aderamastat and MMP-12

Aderamastat is a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. MMP-12 plays a role in asthma pathophysiology and is associated with disease severity. Aderamastat showed sustained anti-inflammatory effects and attenuated allergen-induced histopathology in a mouse model of house dust-mite (HDM). Importantly, a Phase 2 allergen challenge asthma proof-of-concept study has been successfully completed.

The key role of MMP-12 in disease is supported by single-nucleotide polymorphisms/genetic evidence related to inflammatory-fibrotic diseases, including asthma and COPD. MMP-12 is a key immune-fibrotic modulator secreted by macrophages and a key regulator of macrophage, neutrophil, and lung epithelial cell biology and becoming increasingly recognized as a key marker of inflammatory exacerbations and fibrosis.

About Foresee Pharmaceuticals Co., Ltd.

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (6576.TWO). 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, and EU and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI® 21 mg. The U.S. regulatory submission is anticipated in 2024. The second indication of CAMCEVI® 42 mg – central precocious puberty (CPP), the phase 3 clinical study, has been initiated. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, 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-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 Fanconi Anemia study is currently being initiated, and a P2 study in pulmonary hypertension group 3 patients is in planning. www.foreseepharma.com