Verdiva Bio Initiates Phase 1 Study of VRB-103, a Selective Oral Amylin Peptide Analog With Weekly Dosing Potential

• VRB-103, a potential once-weekly, selective oral amylin analog, is being evaluated in a Phase 1 study as both a monotherapy and in combination with VRB-101 (oral ecnoglutide), a once-weekly oral GLP-1 analog
• Once-weekly oral dosing of both VRB-103 and VRB-101 enabled by clinically validated, potential best-in-class peptide delivery platform
• VRB-103 is the first known, once-weekly oral amylin analog currently in clinical development
• Initial data currently anticipated by the end of 2026

LONDON & SAN FRANCISCO--(BUSINESS WIRE)--Verdiva Bio Limited (“Verdiva Bio” or the “Company”), a clinical-stage biotechnology company advancing the development of a portfolio of once-weekly oral candidates for obesity and obesity-related disorders, today 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.

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).

VRB-103 is the first known once-weekly, amylin receptor-selective, oral amylin peptide analog currently in clinical development. Preclinical data demonstrated VRB-103 to have a differentiated profile with strong potency and high amylin receptor selectivity, with a comparable pharmacokinetic profile to VRB-101. VRB-103 also leverages Verdiva's investigational proprietary oral peptide delivery platform.

“The initiation of the VRB-103 Phase 1 study marks an important milestone for Verdiva and highlights our growing momentum as we move our second oral peptide into the clinic,” said Steve Marso, Chief Medical Officer at Verdiva Bio. “Obesity is a complex, chronic disease, and we’re committed to developing differentiated next-generation obesity candidates. VRB-103 has the potential to deliver a convenient, once-weekly oral treatment, with a clinically meaningful efficacy and tolerability profile for patients looking for alternatives to GLP-1 therapies.”

About VRB-103

VRB-103, a once-weekly investigational amylin receptor-selective, oral amylin analog, is being developed to address both the induction and maintenance phases of weight loss in patients living with overweight or obesity. Amylin agonism represents a non-incretin mechanism of action, offering an alternative therapeutic approach for patients with obesity/overweight, potentially including those who do not respond to or cannot tolerate GLP-1 therapies. VRB-103 is designed to be amylin receptor-selective at human amylin receptor-1 and -3 relative to the human calcitonin receptor. VRB-103 is currently being evaluated in a Phase 1 study and is in development as a monotherapy and in combination with VRB-101, a once-weekly oral GLP-1 analog.

About Verdiva Bio

Verdiva Bio is a next-generation obesity biotech company developing a differentiated portfolio of once-weekly oral drug candidates to help people living with obesity and obesity-related disorders. Using validated science and the Company’s proprietary oral absorption enhancer, Verdiva’s portfolio of once-weekly oral peptide medicines are designed to address the needs of patients across the emerging and diverse obesity market with improved convenience, tolerability, and patient choice. Verdiva Bio’s most advanced investigational candidate, VRB-101, has demonstrated clinical proof-of-concept in Phase 1, including evidence of once-weekly oral dosing feasibility and improved oral bioavailability versus existing daily oral GLP-1 peptides. VRB-101 is currently in Phase 2 development in the United States. The Company is also developing a once-weekly selective oral amylin analog, VRB-103, for use as a monotherapy and in combination with VRB-101, in addition to other undisclosed programs that offer the potential for enhanced efficacy and improved tolerability.

For more information, please visit www.verdivabio.com.