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.