TAIPEI, Aug. 9, 2024
/PRNewswire/ -- Foresee Pharmaceuticals (TPEx: 6576), ("Foresee")
today announced several new developments related to its SIF
long-acting injectable (LAI) technologies, namely the disclosure of
its four novel and proprietary SIF LAI delivery systems:
SIF-ADAGIOTM, SIF-LEGATOTM,
SIF-DUOTM, and SIF-MEZZOTM.
Building on the tremendous success of its first SIF-derived
product CAMCEVI®, Foresee has been continuously
developing and expanding its SIF technology platform as well as its
industry dominance and leadership in the area of LAI's, from the
technology, intellectual property and product development
perspective. In view of the complexity of LAI's, requiring a
remarkable depth of know-how, expertise, and experience, very few
organizations have developed a LAI technology platform with the
level of flexibility and adaptability that can be found in the SIF
platform. In fact, Foresee has now developed four distinct SIF LAI
delivery systems that will enable even greater flexibility and
allow to continue to push the boundaries of innovation in complex
LAI products. Foresee will be disclosing more information on these
new SIF delivery systems over the upcoming months. Below is a
summary:
Foresee's commercial product CAMCEVI® was
developed using its SIF-ADAGIOTM delivery system, based
on biodegradable polymers. Foresee is also applying its
SIF-ADAGIOTM system to other products in the portfolio,
namely FP-014, its best-in-class ready-to-use, subcutaneous, 3 and
6-month triptorelin LAI. The SIF-LEGATOTM system is a
novel combination lipid-based system that has the unique advantage
of permitting very high drug loading, making it highly adaptable to
various drug substances and product profiles. This SIF LAI delivery
system is currently being employed for the development of several
early neurology products in our portfolio. SIF-DUOTM is
a solution-based system which Foresee is using for the development
of some of its early psychiatry LAI programs that benefit from this
unique delivery system, while our SIF-MEZZOTM delivery
system remains in development and optimization phase.
"We are pleased to announce these recent developments in our SIF
LAI technologies," said Dr. Ben
Chien, Foresee's Chairman and CEO. "While we remain very
committed to the advancement of our product portfolio across both
SIF and NCE programs, we continue to make significant strides in
advancing the technology and intellectual property foundations on
which we have built our company. A key part of our mission is to
remain a leader in complex LAI products and technologies."
"We are very enthusiastic about the promise of these emerging
SIF delivery systems. We have proven the value of our technology
and expertise through the application of our
SIF-ADAGIOTM system to CAMCEVI®, a
best-in-class product growing successfully in the market, now we
are ready to embark in the second phase of our mission by
demonstrating the commercial potential of the new delivery
systems," said Dr. Yuhua Li,
Foresee's Chief Technology Officer.
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, Taiwan and Israel and launched in the U.S. in
April 2022. Additionally, U.S. and EU
regulatory submissions are under preparation for
CAMCEVI® 21 mg. For 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, has been investigated in 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-020, a follow-on oral MMP-12
inhibitor currently in Phase 1, with development targeted in severe
asthma, COPD and IBD. FP-045 is 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 the Phase 2 WINDWARD
study in pulmonary hypertension-interstitial lung disease (PH-ILD)
patients is in planning with targeted initiation in the fourth
quarter of 2024. Building on the compelling biology of ALDH2, and
translational data from several Foresee ALDH2 activators, a
follow-on candidate from a new series of compounds is being
selected for development in metabolic syndrome/healthy weight loss
and the broader cardiovascular-renal-metabolic space.
www.foreseepharma.com
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SOURCE Foresee Pharmaceuticals Co., Ltd.