Market Overview

Melior Pharmaceuticals Initiates Phase 2b Study with MLR-1023 for Type 2 Diabetes


-First patient dosed in Phase 2b Study-

- Study recruiting 400 patients across 61 sites in 2 countries -

Pharmaceuticals I, Inc.
announced today that it has randomized the
first patient into treatment arms of a Phase 2b study aimed at
evaluating the efficacy of MLR-1023 in adults with uncontrolled Type 2
diabetes on metformin therapy. The 12-week treatment protocol will
enroll 400 subjects across 61 clinical sites in the U.S. and Korea. The
study is a joint development effort between Melior Pharmaceuticals I
(USA) and Bukwang Pharmaceutical Company (Korea).

This study follows a positive Phase 2a proof-of-concept study that the
partners completed last year in which statistically significant glucose
lowering was achieved for both glucose parameters (fasting plasma
glucose and area-under-the curve in a mixed meal tolerance test). In
addition, positive trends were seen in lipid parameters and body weight
in that 4-week study.

"Given the positive results we showed in our first study, we continue to
expect MLR-1023 to represent a ground-breaking therapy as the first in a
new class of insulin sensitizers that is not associated with the
untoward effects of PPAR-active compounds," said Andrew Reaume, CEO of
Melior Pharmaceuticals I.

MLR-1023 is an oral insulin sensitizer in development for the treatment
of Type 2 diabetes. It improves glycemic control by directly and
selectively activating the Lyn tyrosine kinase enzyme, which has been
shown to modulate insulin-signaling pathways independently of
PPAR-related interactions. Preclinical studies show that MLR-1023 has
the potential to lower blood glucose levels more effectively than
existing therapies without the risk of hypoglycemia or weight gain. It
improves beta cell function in animal models of diabetes and combines
well with current anti-diabetes drugs. Melior expects MLR-1023 will be
dosed once daily.

About Melior

Melior Discovery and its sister company, Melior Pharmaceuticals
I, are leaders in pharmaceutical drug repositioning using the unique theraTRACE®
platform comprised of multiplexed in vivo disease models. Melior
is using these capabilities to build an internal pipeline of development
candidates and also partners with pharmaceutical and biopharmaceutical
companies to apply the theraTRACE® platform and its
in-depth in vivo pharmacology expertise to their development
candidates. Melior Discovery and Melior Pharmaceuticals are privately
held and located in Exton, PA. For more information, visit

About Bukwang Pharmaceutical Company, Ltd.

Bukwang Pharm. Co., Ltd. is a leading Korean pharmaceutical company
listed on the Korean Stock Exchange [KRX:003000]. The company has been
in business for over 50 years. Sales are primarily derived from products
licensed from Europe, the United States and Japan. The company is
currently investing significant resources in R&D to create a robust
pipeline of preclinical and clinical agents for the treatment of
oncology, gastrointestinal disorders, CNS disorders and metabolic

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