ecnoglutide oral (VRB-101) / Sciwind Biosci - LARVOL DELTA

VRB101 Is a Potent Oral GLP-1 Tablet with Once-Weekly Dosing Potential (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Metabolic Disorders

Sciwind Biosciences Announces Global Licensing and Collaboration Agreement for Metabolic Disease Portfolio (PRNewswire) - "Hangzhou Sciwind Biosciences...today announced a licensing and collaboration agreement for the global development and commercialization of a portfolio of metabolic diseases therapies in territories outside of Greater China and South Korea, with Verdiva Bio Limited ('Verdiva')...The partnered portfolio under this collaboration includes: Oral Ecnoglutide (Ecnoglutide Oral, XW004): A phase 2-ready, potential first-in-class, once-weekly oral GLP-1 receptor agonist. Oral Amylin Receptor Agonist (Amylin RA): A potential first-in-class, once-weekly long-acting, oral amylin receptor agonist in IND-enabling studies. Subcutaneous injectable Amylin Receptor Agonist (Amylin RA): A potential best-in-class, long-acting, amylin receptor agonist in IND-enabling studies....Under the agreement, Sciwind receives an upfront consideration totaling approximately $70 million, and is eligible to receive more than $2.4 billion in milestone payments for development,..."

Licensing / partnership • Metabolic Disorders • Obesity

Phase 1 topline safety, efficacy, and pharmacokinetics of oral ecnoglutide (EASD 2024) - P1 | "Oral ecnoglutide (XW004) is formulated with an absorption enhancer, PNAC (T2026)... Oral ecnoglutide was safe and well tolerated and resulted in pronounced weight loss after 6 weeks of dosing. Improved oral bioavailability enables a daily dose of 15 to 30 mg oral ecnoglutide to match or exceed the plasma exposure of weekly subcutaneous GLP-1 analogs. The pharmacokinetics of oral ecnoglutide also suggest the possibility of once weekly oral dosing, which is being explored in the ongoing study."

Clinical • P1 data • PK/PD data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Sciwind Biosciences to Highlight Positive Results for Injectable Ecnoglutide (Phase 3), Oral Ecnoglutide (Phase 1), and Novel Amylin Analogs at the American Diabetes Association (ADA) 84th Annual Conference (PRNewswire) - P3 | N=664 | NCT05813795 | P1 | N=90 | NCT05184322 | Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. | "A Phase 1 study of oral ecnoglutide (1871-LB) showed it to be safe and well tolerated and result in pronounced weight loss (up to -6.76% after 6 weeks of dosing). Improved oral bioavailability enables a 15 to 30 mg daily dose of oral ecnoglutide to match or exceed the plasma exposure of weekly subcutaneous GLP-1 analogs for weight loss. In a Phase 3 study in participants with type 2 diabetes (T2DM) (742-P, 793-P), weekly subcutaneous ecnoglutide resulted in robust HbA1c declines of up to -2.43% from baseline after 24 weeks of treatment, with up to 35.2% of participants reaching normoglycemia (HbA1c <5.7%) and 43.7% with weight reductions ≥5%....Sciwind Biosciences Co., Ltd... today announced that the company will present...at the American Diabetes Association (ADA) 84th Annual Conference."

P1 data • P3 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. | Not yet recruiting ➔ Recruiting | N=56 ➔ 90 | Trial completion date: Feb 2023 ➔ Aug 2024 | Trial primary completion date: Dec 2022 ➔ Jul 2024

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Phase 1 Topline Safety, Efficacy, and Pharmacokinetics of Oral Ecnoglutide (ADA 2024) - "Oral ecnoglutide (XW004) is formulated with an absorption enhancer, PNAC (T2026)... Oral ecnoglutide was safe and well tolerated and resulted in pronounced weight loss after 6 weeks of dosing. Improved oral bioavailability enables a daily dose of 30 mg oral ecnoglutide to match or exceed the plasma exposure of weekly subcutaneous GLP-1 analogs. Oral ecnoglutide has a potential to be a best-in-class oral GLP-1RA."

Clinical • Late-breaking abstract • P1 data • PK/PD data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Sciwind Biosciences Announces Positive Results from Phase 1 Clinical Trial of XW004, an Oral Formulation of Long-acting GLP-1 Analog Ecnoglutide (PRNewswire) - P1 | N=56 | NCT05184322 | Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. | "Sciwind Biosciences...announced positive interim results from the first four cohorts of a Phase 1 clinical trial of oral ecnoglutide (XW004)....At baseline, participants had a mean body weight of 75.6 to 77.9 kilograms for Cohorts 1-3 and 100.1 kilograms for Cohort 4. Mean BMI at baseline was 25.8 to 26.1 kg/m² for Cohorts 1-3 and 32.9 kg/m² for Cohort 4. In Cohorts 1-3, treatment with doses up to 7, 15, or 30 mg XW004 once-daily for 2 weeks resulted in body weight changes of -3.6%, -3.4%, and -6.6%, respectively, compared to -0.9% for the placebo group. In obese participants (Cohort 4), treatment with doses up to 30 mg XW004 once-daily for 6 weeks resulted in -6.8% body weight loss at end of treatment, compared to -0.9% for the placebo group. In addition, pharmacokinetics of XW004 showed good absorption after oral administration."

P1 data • Obesity • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients (clinicaltrials.gov) - P3 | N=210 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients (clinicaltrials.gov) - P3 | N=210 | Not yet recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults (clinicaltrials.gov) - P1; N=56; Not yet recruiting; Sponsor: Sciwind Biosciences APAC CO Pty. Ltd.

Clinical • New P1 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus