Foresee Pharmaceuticals Announces First Subject Dosed in its First-in-Human Clinical Trial of FP-020
2024-04-30
临床1期临床2期上市批准免疫疗法
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 inhibitorsMMP-12 inhibitors across several therapeutic areas."
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.
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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