– Gan & Lee Pharmaceuticals Announces Major Advances in New Treatments for Diabetes and Obesity at the American Diabetes Association’s 84th Scientific Session
BEIJING and BRIDGEWATER, NJ, June 24, 2024 /PRNewswire/ — Gan & Lee Pharmaceuticals (Gan & Lee, Stock Exchange Shanghai: 603087) announced the results of the phase clinical study 1 B/2a of the company’s independently developed glucagon-like peptide-1 (GLP-1) receptor agonist, GZR18 injection, in an overweight/obese population in China, along with results from two other preclinical studies insulin innovators in poster presentations at the 84th Scientific Session of the American Diabetes Association (ADA).
This Phase 1 clinical study 1 B/2a, randomized, double-blind, placebo-controlled, and dose-escalation evaluated the safety, tolerability, pharmacokinetics, and efficacy of GZR18 injection in obese/overweight Chinese subjects after multiple once-weekly (QW) administration or biweekly (Q2W) dosing interval. A total of 36 obese participants were enrolled in the study and randomized in a 3:1 ratio to receive dose titration from 1.5 mg to 30 mg of GZR18 injection or a matching placebo for a total of 35 weeks.
The study results demonstrated superior efficacy of GZR18 injection than placebo for weight reduction in obese Chinese 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 not a head-to-head study, compared to published data on weight loss from similar products currently available on the market, the weight loss ability of GZR18 outperformed semaglutide and dual-incretin receptor-targeted tirzepatide in a study of similar 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%).
Additionally, the percentage of participants achieving weight reductions of ≥5%, 10%, and 15% from baseline was 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% or more.
In terms of safety, GZR18 injection was well tolerated in obese participants. The most frequently reported adverse events (AEs) during treatment were those related to the gastrointestinal system, and all were mild to moderate in severity. This is consistent with incretin-based therapies approved for the treatment of obesity and overweight and occurred primarily in the initial 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 30-week, multicenter, placebo-controlled, randomized, double-blind, Phase 2 clinical study evaluating the efficacy and safety of GZR18 injection in Chinese adults with obesity and overweight. 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 part of Phase 2 has now been completed and data from the preliminary study further support the results of the Phase 2 obesity/overweight study. 1 B/2a reported, particularly the positive results achieved with a biweekly dosing frequency.
“We are very excited about the clinical results of the GZR18 program to date,” said Dr. Gan Zhong-ru, founder of Gan & Lee. “Our unique molecular design delays the onset of drug action and attenuates the peak effect, thereby improving drug tolerability and achieving gradual, gentle and sustained weight loss. In addition, GZR18 has a longer duration of action, which “It is expected to be administered once every two weeks, 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.”
Additionally, Gan & Lee announced preclinical trial results for the company’s investigational products GZR4, a weekly insulin analog, and GZR101, a premixed dual insulin analog, at the 84th ADA Scientific Sessions:
GZR4 insulin analogue once a week
GZR4 is a new 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 weekly insulin analogue. Furthermore, unlike insulin Icodec, GZR4 maintains its insulin receptor activation activity after binding to albumin. In studies using animal models of diabetes, the hypoglycemic effect of GZR4 was observed to be 2-3 times greater than that of insulin Icodec. Based on preclinical results, GZR4 is expected to be the fourth-generation basal insulin that can be administered once a week to achieve effective glycemic control.
GZR101 Premixed Insulin Analogue
GZR101 injection is a premixed insulin analog made from a combination of GZR33 ultra-long-acting basal insulin injection and rapid-acting insulin aspart (Rapilin®). Unlike traditional premixed insulin analogues, the duration of the glucose-lowering effect of the basal insulin component (GZR33) in GZR101 can last for 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 produce a premixed insulin analog, it can achieve smooth fasting and postprandial blood glucose control throughout the day. In diabetic animal models, GZR101 is significantly superior to insulin degludec/insulin aspart (IDegAsp) in blood glucose reduction and safety. As a premixed insulin analogue developed based on an advanced concept, GZR101 is expected to make an important contribution to blood glucose control and reducing the risk of hypoglycemia in patients with diabetes globally.
Conclusions and future directions
The 84th ADA Scientific Sessions highlighted Gan & Lee Pharmaceuticals’ leadership in developing next-generation treatments for diabetes and obesity. With these latest preclinical and clinical results, the company will continue to advance the development of innovative therapies for diabetes. While ongoing studies and upcoming trials will further support the positive influence of these innovative medicines on public health problems 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/
- 84th ADA Scientific Sessions. https://professional.diabetes.org/scientific-sessions
About Gan & Lee
Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analogue. Currently, Gan & Lee has six main insulin products, including five varieties of insulin analogues: long-acting glargine injection (Basalin®), rapid-acting lispro injection (Prandilin™), rapid-acting aspart injection (Rapilin ®), protamine zinc lispro (25R) mixed injection (Prandilin™25), aspart 30 injection (Rapilin®30) and a human insulin injection: protamine mixed (30R) human insulin injection (Similin®30). The company has two approved medical devices in China: a reusable insulin injection pen (GanleePen) and a disposable pen needle (GanleeFine®).
In the Specific National Centralized Acquisition of Insulin china from 2024, Gan & Lee Pharmaceuticals ranked second overall and first among domestic companies in terms of insulin analog procurement demand. The company is also advancing into 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 will significantly boost Gan & Lee’s competitiveness in domestic and international markets.
In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Advancing 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.
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