Press Release

Foresee Pharmaceuticals Presents Data From its Aderamastat Program at The European Respiratory Society (ERS) International Congress 2023

Late-breaking oral presentation on the positive primary outcomes of aderamastat, a first-in-class, oral MMP-12 inhibitor in a Phase 2 Phase 2 proof-of-concept allergic asthma study, supporting potential novel anti-inflammatory mechanism for respiratory diseases.

Taipei, Taiwan, September 11th, 2023 – Foresee Pharmaceuticals (TPEx: 6576), (“Foresee”) announced today that the company presented 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 focused on the primary results from the assessment of the efficacy of multiple oral doses of aderamastat in HDM-allergic asthma patients.

Summary and Preliminary Findings Highlighted in the Presentation:

  • All subjects who received FP-025 (aderamastat) had good plasma exposure of FP-025
  • Overall, FP-025 (aderamastat) was safe and well tolerated in subjects with mild allergic asthma
  • The primary Endpoint of LAR (FEV1 AUC-3-8) was met, which suggests that FP-025 (aderamastat) demonstrates clinically meaningful protection against allergen-induced asthma
  • There has been a lesser increase in allergen-induced FeNO in subjects who received FP-025 (aderamastat) compared to the placebo
  • There have been positive trends in spec IOS parameters (e.g., R5, Fres, AX, and X5), which support the overall response
  • A carry-over effect was encountered when FP-025 was administered in Period 1, which suggests a long-term FP-025 sustained efficacy

"We are very pleased with the outcome of the presentation of our Phase 2 proof-of-concept study data at ERS. It was a real pleasure to share this promising data with such a remarkable group of scientists and clinicians in the field of respiratory diseases. It was also very encouraging to see aderamastat, and MMP-12 highlighted as a novel key inflammatory pathway that contributes to asthma and potentially other lung diseases," said Dr. Yisheng Lee, Chief Medical Officer at Foresee.

"This Phase 2 study demonstrates that the inhibition of MMP-12 in humans is 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, and are very confident in the opportunity and value of conducting additional Phase 2 studies as we explore partnering opportunities which may create strong value for our MMP-12 program and our shareholders," said Dr. Ben Chien, Chairman and CEO at Foresee.

"Our main objective is 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, and Foresee has laid very strong foundations to build in this direction," added Dr. Chien.

The presentation is available on the Foresee website. https://www.foreseepharma.com/en-us/event/22

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 house dust mite (HDM) mouse model. 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 is 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 (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 and Taiwan and launched in the U.S. in April 2022. Additionally, U.S. and EU regulatory submissions are under preparation for CAMCEVI® 21 mg. 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 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 Phase 2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning. www.foreseepharma.com