Sciwind Biosciences has reported positive topline results from a Phase III clinical trial of ecnoglutide (XW003), a long-acting, cyclic adenosine 3′,5′-monophosphate (cAMP) signalling biased glucagon-like peptide-1 (GLP-1) analogue, in adult type 2 diabetes mellitus (T2DM) patients in China.
The double-blind, randomised, placebo-controlled trial enrolled 211 subjects across 33 sites in the country.
Subjects with inadequately controlled T2DM were randomised to receive weekly injections of ecnoglutide or a placebo for 24 weeks, including a dose escalation period.
Variations in mean haemoglobin A1c (HbA1c), body mass index (BMI), body weight, tolerability, and safety were assessed int the trial.
After 24 weeks, subjects who were given ecnoglutide attained a statistically significant decline in HbA1c.
Most of the subjects in the ecnoglutide arm attained HbA1c levels below 7%, and a substantial portion also had HbA1c levels below 5.7%.
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Significant weight loss was also observed in participants receiving ecnoglutide.
Ecnoglutide’s safety and tolerability profile in the trial was in line with that of GLP-1 receptor agonists.
Sciwind Biosciences CEO Hai Pan said: “We are very pleased to see the positive results from the first Phase III 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 analogues, such as tirzepatide.
“The strong efficacy we are seeing with ecnoglutide in clinical studies is consistent with its cAMP signalling biased mechanism of action.”
Apart from this Phase III trial in T2DM patients, ecnoglutide is also being analysed in two other Phase III studies.
These studies are fully enrolled and are assessing ecnoglutide versus dulaglutide in T2DM, and ecnoglutide versus a placebo in people who are overweight or obese.
Trial data from both studies are anticipated in the second half of next year.
In October 2022, the company began dosing subjects in a Phase I trial of XW014 in development to treat obesity and type 2 diabetes.