PR Newswire
TAIPEI , April 30, 2024 /PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announced that the first subject has been dosed in its Phase 1 clinical trial of FP-020 in Australia .
The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single-center, single, and multiple ascending oral dose study to evaluate the safety, tolerability, and pharmacokinetics of FP-020 in healthy volunteers. Up to 74 subjects will be enrolled at a site in Australia .
"We are pleased to announce the dosing of the first subject in this Phase 1 clinical study, marking a significant milestone in the development of FP-020," said Dr. Ben Chien , Foresee's Chairman and CEO. "The initiation of this Phase 1 trial underscores our commitment to advancing innovative therapies to benefit patients with severe asthma and COPD. Additionally, we are working diligently to build a broad franchise leveraging our multiple MMP-12 inhibitors across several therapeutic areas."
"We are very enthusiastic about the promise of FP-020 as a best-in-class MMP-12 inhibitor, a pipeline-in-a-drug opportunity with potential for once-a-day oral dosing," said Dr. Wenjin Yang , Foresee's Chief Scientific Officer.
About FP-020 and MMP-12
FP-020 is a highly potent and selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases. FP-020 is the new-generation MMP-12 inhibitor developed by Foresee following aderamastat. It exhibits excellent pharmaceutical properties, with greater potency and similarly high selectivity compared to aderamastat. FP-020 has shown a favorable efficacy profile in multiple animal models of idiopathic pulmonary fibrosis and sarcoidosis. MMP-12 plays a role in asthma pathophysiology and is associated with disease severity. A Phase 2 allergen challenge asthma proof-of-concept study in aderamastat 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 on 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 being prepared for CAMCEVI ® 21 mg. 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, 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-020, a follow-on oral MMP-12 inhibitor currently in Phase 1, with development targeted in severe asthma and COPD. FP-045 – 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 a Phase 2 study in pulmonary hypertension-interstitial lung disease (PH-ILD) patients is in planning. www.foreseepharma.com
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SOURCE Foresee Pharmaceuticals Co., Ltd.
