VRB-103 / Sciwind Biosci, Verdiva Bio - LARVOL DELTA

VRB-103 is a potent, orally bioavailable amylin analog with a strong selectivity towards human amylin receptors versus calcitonin receptor (EASD 2026) - "Clinical stage amylin analogs, such as cagrilintide and eloralintide, have demonstrated distinct profiles for tolerability and body weight reduction with weekly subcutaneous administrations. VRB-103 is a potent and orally bioavailable amylin analog with a strong selectivity towards human amylin receptors relative to hCTR. The amylin receptor selectivity of VRB-103 was more pronounced than that of the comparators analyzed. VRB-103 is currently in development as a once-weekly oral tablet for obesity."

Metabolic 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

Verdiva Bio Limited…announces that the first patient has been dosed in a Phase 1 SAD study evaluating VRB-103, a once-weekly selective oral amylin analog, as a treatment for overweight and obesity (Businesswire) - "The Phase 1 randomized, double-blind, placebo-controlled study will assess the safety and tolerability of VRB-103, in healthy patients with an elevated BMI. The study will evaluate VRB-103 alone and in combination with VRB-101, including assessment of multiple combination dose ratios. Verdiva currently anticipates initial Phase 1 data at the end of 2026 (Study ID: NCT07628127)."

P1 data • Trial status • Obesity

VRB-103 Is a Potent, Orally Bioavailable Amylin Analog with a Strong Selectivity towards Human Amylin Receptors vs. Calcitonin Receptor (ADA 2026) - "Clinical stage amylin analogs, such as cagrilintide and eloralintide, have demonstrated distinct profiles for tolerability and body weight reduction with weekly subcutaneous administrations. VRB-103 is a potent and orally bioavailable amylin analog with a strong selectivity towards human amylin receptors relative to hCTR. The amylin receptor selectivity of VRB-103 was more pronounced than that of the comparators analyzed. VRB-103 is currently in development as a once-weekly oral tablet for obesity."

Metabolic 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

Verdiva Bio to Present Preclinical Data on Investigational Obesity Drug Candidates at the American Diabetes Association 86th Scientific Sessions (Businesswire) - "The presentations include new preclinical data for VRB-103, a once-weekly oral amylin receptor-selective amylin analog, and VRB-104, a unimolecular GLP-1 plus amylin co-agonist."

Preclinical • Obesity

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

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