Study participants receiving 0.6 and 1.2 mg ecnoglutide once weekly for 24 weeks achieved HbA1c reductions of 1.96 and 2.43% from baseline, respectively, compared to 0.87 % for placebo In the 1.2 mg ecnoglutide cohort, 76.1% of participants achieved HbA1c ≤ 6.5% and 35.2% achieved HbA1c < 5.7% at the end of the 24-week treatment Ecnoglutide was safe and well tolerated with gastrointestinal side effects as the most commonly reported adverse events
HANGZHOU, China and SAN FRANCISCO, Jan. 3, 2024 /PRNewswire/ — Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic diseases, today announced positive topline results from a Phase 3 clinical trial of ecnoglutide (XW003) in Chinese adults with type 2 diabetes mellitus (T2DM). Ecnoglutide is a long-acting, cAMP signaling biased, glucagon-like peptide-1 (GLP-1) analog that is being developed for the treatment of type 2 diabetes and obesity.
The Phase 3 trial (NCT05680155) is a randomized, double-blind, placebo-controlled study that enrolled 211 participants at 33 sites in China. Eligible subjects had T2DM that was inadequately controlled by diet and exercise. Participants were randomized to receive ecnoglutide (0.6 mg or 1.2 mg) or placebo as once weekly injections for 24 weeks, including a dose escalation period. Analysis was conducted at week 24 to allow comparison of ecnoglutide with placebo. All participants were then eligible to receive open label ecnoglutide at target doses of 0.6 or 1.2 mg for a total treatment duration of 52 weeks. Changes in mean HbA1c, body weight and BMI, as well as safety and tolerability were evaluated. At baseline, participants had a mean HbA1c of 8.5% and mean body weight of 73 kilograms.
After 24 weeks of treatment, participants receiving ecnoglutide achieved statistically significant reductions in HbA1c. The majority of the participants receiving ecnoglutide achieved HbA1c of less than 7% (the American Diabetes Association’s recommended target for people with diabetes) and a significant proportion achieved HbA1c of less than 5.7%. There were also significant body weight decreases for participants receiving ecnoglutide. Key topline efficacy results of the study are summarized in the table below.
Summary of Efficacy Results
Week 24
Placebo
(N=71)
0.6 mg ecnoglutide
(N=69)
1.2 mg ecnoglutide
(N=71)
HbA1c change from baseline
-0.87 %
-1.96%
(P=0.0003)
-2.43%
(P<0.0001)
Percent of participants achieving HbA1c < 7%
21.1 %
68.1 %
80.3 %
Percent of participants achieving HbA1c ≤ 6.5%
12.7 %
52.2 %
76.1 %
Percent of participants achieving HbA1c < 5.7%
0 %
10.1 %
35.2 %
Percent body weight change from baseline
-2.02 %
-4.51%
(P=0.0002)
-4.74%
(P<0.0001)
Overall safety and tolerability of ecnoglutide in this study was consistent with the established profile of GLP-1 receptor agonists. The most frequently reported adverse events included decreased appetite, diarrhea, and nausea, and majority of the AEs were mild to moderate in severity. A total of three subjects, one (1.4%) from each cohort, discontinued the study due to adverse events.
"We are very pleased to see the positive results from the first Phase 3 clinical trial of ecnoglutide in China. The HbA1c reductions observed after 24 weeks of treatment are very promising and are comparable to the treatment effects seen with dual GLP-1/GIP analogs such as tirzepatide," said Hai Pan, CEO of Sciwind Biosciences. "The strong efficacy we are seeing with ecnoglutide in clinical studies is consistent with its cAMP signaling biased mechanism of action."
In addition to this Phase 3 trial in T2DM patients, which is expected to complete in the first half of 2024, ecnoglutide is also being evaluated in two additional Phase 3 trials. These fully enrolled trials are investigating ecnoglutide versus dulaglutide in T2DM (NCT05680129) and ecnoglutide versus placebo in participants with overweight or obesity (NCT05813795). Results from both pivotal studies are expected in the second half of 2024.
About ecnoglutide (XW003)
Glucagon-like peptide-1 (GLP-1) analogs are effective therapies in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for NASH. Ecnoglutide (XW003) is a novel, cAMP signaling biased, long-acting GLP-1 analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing. XW003 has demonstrated treatment benefits for patients with type 2 diabetes and obesity and is safe and well tolerated in completed clinical studies.
About Sciwind
Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Its product pipeline consists of potentially first-in-class and best-in-class drug candidates, including the long-acting GLP-1 peptide analog ecnoglutide (Phase 3), oral GLP-1 peptide analog XW004 (Phase 1), and oral small molecule GLP-1 receptor agonist XW014 (Phase 1). Sciwind has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutic delivery platforms and identified a series of drug candidates based on these core platform technologies. For more information, visit www.sciwindbio.com.
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