Positive Phase 1 Results for Sciwind's Oral GLP-1 Analog Ecnoglutide

Sciwind Biosciences has reported positive interim outcomes from its Phase 1 clinical trial of an oral formulation of ecnoglutide (XW004), a long-acting GLP-1 analog. The drug is being developed to treat type 2 diabetes and obesity. In the trial, oral ecnoglutide demonstrated safety and tolerability, with gastrointestinal side effects being the most common adverse events. Participants who received up to 30 mg of the drug daily for six weeks experienced an average weight loss of 6.8% from baseline, significantly more than the 0.9% loss in the placebo group.

The trial, which is ongoing, is designed to assess different dosing schedules, including a once-weekly oral administration. The study involved 42 healthy individuals and 14 healthy obese participants in Australia. They were given either a placebo or varying doses of XW004 as daily oral tablets. The adverse events were mostly mild to moderate and occurred primarily during the dose-escalation phase.

Initial body weights of participants ranged from 75.6 to 77.9 kilograms for the first three cohorts and 100.1 kilograms for the fourth cohort of obese individuals. The corresponding BMIs were between 25.8 to 26.1 and 32.9, respectively. The weight loss percentages after two weeks of treatment with the drug were -3.6%, -3.4%, and -6.6% for the first three cohorts, compared to the placebo's -0.9%. For the obese cohort, the six-week treatment resulted in a -6.8% weight loss.

Hai Pan, Sciwind's CEO, expressed optimism about the study's findings, highlighting the potential of oral ecnoglutide for treating obesity and type 2 diabetes. The company is now exploring less frequent dosing regimens to improve patient compliance and accessibility. If successful, XW004 could become the first once-weekly oral GLP-1 receptor agonist for metabolic conditions.

Ecnoglutide (XW003 and XW004) is a novel GLP-1 analog that has shown promise in managing type 2 diabetes, obesity, and potentially NASH. It is optimized for enhanced biological activity and cost-effective production, with XW004 being its oral tablet version.

Sciwind Biosciences is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for metabolic diseases. Its pipeline includes several drug candidates that are either first-in-class or best-in-class, such as the long-acting GLP-1 peptide analog ecnoglutide, the oral ecnoglutide tablet XW004, and the oral small molecule GLP-1 receptor agonist XW014. The company has also developed proprietary technologies for oral peptide and inhaled protein therapeutic delivery.