BEIJING and BRIDGEWATER, N.J.,
June 22,
2024 /PRNewswire/ -- Gan & Lee Pharmaceuticals
(Gan & Lee, Shanghai Stock Exchange: 603087) announced the
results of the Phase 1b/2a clinical
study of the Company's independently developed glucagon-like
peptide-1 (GLP-1) receptor agonist, GZR18 Injection, in an
obese/overweight population in China, along with the results of two other
innovative insulins' preclinical studies in poster presentations at
the American Diabetes Association's(ADA's)84th Scientific
Sessions.
This randomized, double-blind, placebo-controlled,
dose-escalation Phase 1b/2a clinical
study evaluated the safety, tolerability, pharmacokinetics and
efficacy of GZR18 Injection in Chinese subjects with
obesity/overweight after multiple administration on a once-weekly
(QW) or bi-weekly (Q2W) dosing interval. A total of 36 obese
participants were enrolled in the study and randomized in a 3:1
ratio to receive a dose titration of 1.5 mg to 30 mg of GZR18
Injection or a matching placebo for a total of 35 weeks.
The study results demonstrated a superior efficacy of GZR18
Injection than placebo for weight reduction in Chinese obese
subjects. After 35 weeks of treatment, the mean weight change from
baseline in the GZR18 QW group was -16.5 kg (95% CI: -19.9 kg,
-13.1 kg); the placebo-adjusted mean percent weight change from
baseline was -18.6% (95% CI: -25.5%, -11.6%). Although it was not a
head-to-head study, when compared to the
published data on weight reduction of similar products currently available on the market,
GZR18's weight-reducing ability outperformed Semaglutide and
dual-incretin receptor targeted Tirzepatide in similar study
duration. Meanwhile, the mean weight change from baseline in the
GZR18 Q2W group was -11.3 kg (95% CI: -15.4 kg, -7.2 kg); the
placebo-adjusted mean percent weight change from baseline was
-13.5% (95% CI: -21.0%, -6.0%).
In addition, the percentage of participants achieving weight
reductions of ≥5%, 10%, and 15% from baseline were 100.0%, 90.0%,
and 80.0%, respectively, in the GZR18 QW group, and the percentage
of participants achieving weight reductions of ≥5%, 10%, and 15%
from baseline were 71.4%, 71.4%, and 42.9%, respectively, in the
GZR18 Q2W group. No participant in the placebo group achieved a
weight reduction of 5% and above.
In terms of safety, GZR18 Injection was well tolerated in obese
participants. The most commonly reported adverse events (AE) during
treatment were gastrointestinal related AEs, and all were mild to
moderate in severity. This is consistent with the incretin-based
therapies approved for the treatment of obesity and overweight and
occurred mainly in the early dose-escalation period. There were no
serious hypoglycemic events in this study and no serious adverse
events related to the investigational drug.
Gan & Lee also announced that a multi-center,
placebo-controlled, randomized, double-blind, 30-week Phase 2
clinical study evaluating the efficacy and safety of GZR18
Injection in Chinese adults with obesity and overweight is in
progress. A total of 338 adults with obesity or overweight were
enrolled in this study, and the study explores a broader dose range
and frequency of administration. The main body of the Phase 2 has
now been completed, and the priliminary study data further support
the results of the reported Phase 1b/2a obese/overweight study, particularly the
positive results achieved with bi-weekly dosing frequency.
"We are very excited about the clinical results of the GZR18
program to the present day." Dr. Gan Zhong-ru, Founder of Gan &
Lee, commented. "Our unique molecular design delays the onset of
drug action and attenuates the peak effect, thereby improving drug
tolerability and achieving smooth and sustained weight loss in a
stepwise manner. Moreover, GZR18 has a longer duration of action,
which is expected to be administered once every two weeks.
Meanwhile, we hope that the clinical results of GZR18 will provide
more evidence to reveal the mechanism of action of different
targets of Incretins and Glucagon."
In addition, Gan & Lee announced the results of preclinical
trials of the company's investigational products: GZR4, a
once-weekly insulin analog, and GZR101, a premixed dual insulin
analog, at the ADA's 84th Scientific Sessions:
Once-weekly Insulin Analog GZR4
GZR4 is a novel ultra-long-acting basal insulin analog designed
for once-weekly administration. Results from preclinical studies
have shown that GZR4 has a significantly higher affinity for human
serum albumin (HSA) and a significantly lower affinity for the
insulin receptor than insulin Icodec, another once-weekly insulin
analog. Moreover, unlike insulin Icodec, GZR4 maintains its
activity in activating the insulin receptor after binding to
albumin. In the studies using animal models of diabetes, the
glucose-lowering effect of GZR4 was observed to be 2-3 times
greater than that of insulin Icodec. Based on the preclinical
results, GZR4 is expected to be the fourth-generation basal insulin
that can be administered once a week to achieve an effective
glycemic control.
Premixed Insulin Analog GZR101
GZR101 injection is a premixed insulin analog made from a
combination of ultra-long-acting basal insulin GZR33 injection and
rapid-acting insulin aspart (Rapilin®). Different
from traditional premixed insulin analogs, the duration of
glucose-lowering effect of basal insulin component (GZR33) in
GZR101 can last 72 hours, and there is no significant peak within
24 hours after reaching a steady state with multiple
injections. When combined with insulin aspart
(Rapilin®️) to make a premixed insulin analog, it can
achieve smooth control of fasting and postprandial blood glucose
throughout the day. In diabetic animal models, GZR101 is
significantly superior than insulin degludec/insulin aspart
(IDegAsp) in blood glucose reduction and safety. As a premixed
insulin analog developed based on an advanced concept, GZR101 is
expected to make an important contribution to the control of blood
glucose and the reduction of the risk of hypoglycemia in patients
with diabetes globally.
Conclusions and Future Directions
The ADA's 84th
scientific sessions highlighted Gan & Lee Pharmaceuticals'
leadership in developing next-generation diabetes and obesity
treatments. With these latest preclinical and clinical results, the
Company will continue to advance the development of innovative
therapeutics for diabetes. While ongoing studies and upcoming
trials will further support the positive influence of these
innovative medicines on public health issues related to diabetes
and obesity.
Forward-looking Statements
Forward-looking statements
are based on our expectations and assumptions as of the date of the
statements. Actual results may differ materially from those
expressed in these forward-looking statements due to a variety of
factors, and we can give no assurance that such results will be
achieved in the future. We undertake no obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events, or otherwise.
References:
- American Diabetes Association. https://diabetes.org/
- ADA's 84th Scientific Sessions.
https://professional.diabetes.org/scientific-sessions
About Gan & Lee
Gan & Lee
Pharmaceuticals developed the first Chinese domestic insulin
analog. Currently, Gan & Lee has six core insulin
products, including five insulin analog varieties: long-acting
glargine injection (Basalin®), fast-acting lispro
injection (Prandilin™), fast-acting aspart injection
(Rapilin®), mixed protamine zinc lispro injection (25R)
(Prandilin™25), aspart 30 injection
(Rapilin®30), and one human insulin injection - mixed
protamine human insulin injection (30R)
(Similin®30). The company has two approved
medical devices in China,
namely reusable insulin injection
pen (GanleePen), and disposable pen needle
(GanleeFine®).
In China's 2024 National
Insulin-Specific Centralized Procurement, Gan & Lee
Pharmaceuticals ranked second overall and first among domestic
companies in terms of procurement demand for insulin analogs. The
company is also making strides in international markets, with the
disposable pen needle (GanleeFine®) approved by the US
Food and Drug Administration (FDA) in 2020 and received GMP
inspection approval from the European Medicines Agency (EMA) in
2024. These achievements significantly boost Gan & Lee's
competitiveness in both international and domestic markets.
In the future, Gan & Lee will strive for comprehensive
coverage in diabetes treatment. Moving forward with its mission to
become a world-class pharmaceutical company, Gan & Lee will
also actively develop new chemical entities and biological drugs,
focusing on treatments for metabolic diseases, cardiovascular
diseases, and other therapeutic areas.
Further Information:
BPRD@ganlee.com (Media)
BD@ganlee.com (Business Development)
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