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

A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity (clinicaltrials.gov) - P1/2 | N=126 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | N=84 ➔ 126

Enrollment change • Genetic Disorders • Obesity

A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Trial completion date: Nov 2026 ➔ Apr 2027 | Trial primary completion date: Aug 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

EVOLVE-2: A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P2 | N=206 | Completed | Sponsor: Verdiva Bio Dev Limited | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Trial of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight (clinicaltrials.gov) - P1 | N=336 | Recruiting | Sponsor: Verdiva Bio Dev Limited | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Genetic Disorders • Obesity

A Study of Weekly Oral Dose of Ecnoglutide (VRB-101) for Weight Maintenance in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Verdiva Bio Dev Limited | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Title: VRB-103 Is a Potent, Orally Bioavailable Amylin Analog with a Strong Selectivity towards Human Amylin Receptors vs. Calcitonin Receptor (Businesswire) - "VRB-103 exhibited greater potency than eloralintide and cagrilintide across all three human amylin receptor subtypes, with EC50 values of 0.091 nM for hAMY1R, 0.205 nM for hAMY2R, and 0.009 nM for hAMY3R; When normalized to cagrilintide, VRB‑103 demonstrated greater relative activation of amylin receptors compared with the calcitonin receptor, with 13.7‑, 4.2‑, and 4.8‑fold higher selectivity for hAMY1R, hAMY2R, and hAMY3R versus hCTR, respectively. In contrast, eloralintide showed lower relative selectivity, with 6.4‑, 1.0‑, and 2.0‑fold for hAMY1R, hAMY2R, and hAMY3R versus hCTR, respectively....VRB-103 is currently in preclinical development as a once-weekly oral tablet for obesity and is expected to enter the clinic in H2 2026 as both a monotherapy and in combination with VRB-101, a once-weekly oral GLP-1 analog currently in Phase 2 development."

New trial • Preclinical • Obesity

A Trial of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight (clinicaltrials.gov) - P1 | N=336 | Not yet recruiting | Sponsor: Verdiva Bio Dev Limited

First-in-human • New P1 trial • Genetic Disorders • Obesity

Preclinical and formulation characterisation of a novel amylin analog VRB-102 designed for co-formulation with a GLP-1 receptor agonist for the treatment of obesity and type 2 diabetes (ECO 2026) - "Overall, VRB-102 demonstrated a PK profile compatible with once weekly dosing and in vitro hAMY3 and hCTR activation comparable to cagrilintide. In preclinical animal models, combination of VRB-102 with GLP-1RA VRB-101 induced greater body weight reduction that was at least additive compared to the individual peptides. Moreover, VRB-102 could be co-formulated with VRB-101 at pH 7.4, potentially enabling storage and delivery of both drugs from a single chamber injection device."

Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study of Weekly Oral Dose of Ecnoglutide (VRB-101) for Weight Maintenance in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Verdiva Bio Dev Limited

New P2 trial • Genetic Disorders • Obesity

EVOLVE-2: A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P2 | N=206 | Active, not recruiting | Sponsor: Verdiva Bio Dev Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Verdiva Bio Announces Completion of Enrollment for EVOLVE-2 Phase 2b Study of VRB-101, a Potential Once-Weekly Oral GLP-1 Peptide Analog in Individuals with Obesity (Businesswire) - "The Company currently expects to report topline data from the study by the end of 2026....Verdiva Bio currently expects to initiate Phase 3 clinical trials for VRB-101 during 2027."

Enrollment closed • New P3 trial • P2b data • Obesity

EVOLVE-2: A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Verdiva Bio Dev Limited

New P2 trial • Genetic Disorders • Obesity

A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity (clinicaltrials.gov) - P1/2 | N=84 | Recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity (clinicaltrials.gov) - P1/2 | N=84 | Not yet recruiting | Sponsor: Hangzhou Sciwind Biosciences Co., Ltd.

New P1/2 trial • Genetic Disorders • Obesity

XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults (clinicaltrials.gov) - P1 | N=87 | Completed | Sponsor: Sciwind Biosciences APAC CO Pty. Ltd. | Recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Mar 2025

Trial completion • Trial completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy of a novel oral amylin analogue and the development of an oral GLP-1/amylin co-formulated tablet to produce high in vivo plasma exposures (EASD 2025) - "In a preclinical model, the combination of the amylin analog VRB-103 and GLP-1 analog VRB-101 demonstrated a synergistic effect on body weight reduction. Both VRB-103 and VRB-101 achieved high plasma exposures in cynomolgus monkeys when dosed orally from a single co-formulated tablet containing VRB-103, VRB-101, and the oral permeation enhancer T2026, supporting continued development of the oral GLP-1/amylin combination for the treatment of obesity and type 2 diabetes."

Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

VRB-101 is a potent oral GLP-1 tablet with once-weekly dosing potential (EASD 2025) - P1 | "These exposures are nearing or exceeding the weekly exposure achieved by 2.4 mg subcutaneous semaglutide or 2.4 mg subcutaneous ecnoglutide. This data supports the rationale for VRB-101 to be a QW oral GLP-1 treatment... This data supports the rationale for VRB-101 to be a QW oral GLP-1 treatment. Compared with subcutaneous injections, oral QW 90 mg and 120 mg VRB-101 are projected to match or exceed the weekly exposures of subcutaneous GLP-1 injections. VRB-101 is expected to exert potent weight lowering while improving adherence via a more patient-friendly dosing regimen."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

VRB101 Is a Potent Oral GLP-1 Tablet with Once-Weekly Dosing Potential (ADA 2025) - "These exposures are nearing or exceeding the weekly exposure achieved by 2.4 mg subcutaneous semaglutide or 2.4 mg subcutaneous ecnoglutide. This data supports the rationale for VRB101 to be a QW oral GLP-1 treatment... This data supports the rationale for VRB101 to be a QW oral GLP-1 treatment. Compared with subcutaneous injections, oral QW 90 mg and 120 mg VRB101 are projected to match or exceed the weekly exposures of subcutaneous GLP-1 injections. VRB101 is expected to exert potent weight lowering while improving adherence via a more patient-friendly dosing regimen."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy of a Novel Oral Amylin Analog and the Development of an Oral GLP-1/Amylin Coformulated Tablet to Produce High In Vivo Plasma Exposures (ADA 2025) - "In a preclinical model, the combination of the amylin analog VRB103 and VRB101 demonstrated a synergistic effect on body weight reduction. Both VRB103 and VRB101 achieved high plasma exposures in cynomolgus monkeys when dosed orally from a single co-formulated tablet containing VRB103, VRB101, and T2026, supporting continued development of the oral GLP-1/amylin combination for the treatment of obesity and type 2 diabetes."

Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

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