Verdiva Bio has dosed the first patient in a Phase 1 study of VRB-103, an investigational oral amylin analogue being developed as a potential once-weekly treatment for overweight and obesity.

The randomised, double-blind, placebo-controlled study will evaluate the safety and tolerability of VRB-103 in healthy people with an elevated BMI.

The Phase 1 study will assess VRB-103 as a monotherapy and in combination with VRB-101, Verdiva’s investigational once-weekly oral GLP-1 analogue.

The company expects to report initial Phase 1 data by the end of 2026.

Verdiva said VRB-103 is the first known once-weekly, amylin receptor-selective oral amylin analogue currently in clinical development.

The programme adds a second oral peptide candidate to Verdiva’s clinical pipeline as pharmaceutical companies continue to investigate alternatives and complements to injectable GLP-1 therapies for obesity.

Oral amylin drug enters clinical development

VRB-103 is designed to selectively activate human amylin receptors and is being developed as a non-incretin approach to treating obesity.

Amylin is a hormone involved in appetite regulation and energy balance, and amylin receptor agonism is being investigated as a potential mechanism for weight management.

Verdiva is developing VRB-103 for both the induction and maintenance phases of weight loss, with the drug being evaluated as a standalone treatment and alongside VRB-101.

The company said preclinical studies showed VRB-103 had strong potency and high amylin receptor selectivity, with a pharmacokinetic profile comparable to VRB-101.

However, the candidate is still at an early stage of development and has yet to generate clinical efficacy data in people.

Steve Marso, chief medical officer at Verdiva Bio, said: “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.”

The Phase 1 study is designed to provide initial information on the safety and tolerability of VRB-103 in humans, as well as supporting further clinical development of the candidate.

Potential once-weekly oral dosing

One of the key features of VRB-103 is its potential for once-weekly oral administration.

Most currently available GLP-1-based obesity treatments are administered by injection, while oral peptide delivery has historically presented challenges because peptide molecules can be broken down in the gastrointestinal tract and may be poorly absorbed.

Verdiva is using its investigational oral peptide delivery platform to develop both VRB-103 and VRB-101 as once-weekly oral candidates.

The company is evaluating whether the delivery technology can support the administration of peptide-based medicines at a lower dosing frequency than conventional oral treatments.

The Phase 1 study will initially focus on safety and tolerability rather than establishing whether VRB-103 produces clinically meaningful weight loss.

The trial will assess VRB-103 alone and in combination with VRB-101, including multiple combination dose ratios.

Verdiva said the combination approach is intended to explore the potential of targeting both amylin and GLP-1 pathways.

Obesity pipeline expands beyond GLP-1

VRB-103 represents Verdiva’s move into clinical development of an amylin-based approach alongside its oral GLP-1 programme.

Amylin receptor agonism is being investigated as a separate mechanism from incretin-based therapies and could potentially provide another option for people who do not respond adequately to, or cannot tolerate, existing GLP-1 treatments.

However, the potential role of VRB-103 in obesity treatment will depend on the results of clinical studies, including whether the candidate can demonstrate an appropriate balance of efficacy, safety and tolerability.

The Phase 1 programme is expected to provide the first clinical data for the candidate, with initial results anticipated by the end of 2026.

The development of oral peptide medicines is attracting increasing interest as pharmaceutical companies seek alternatives to injectable treatments and investigate ways to improve convenience and treatment access.

For Verdiva, the progress of VRB-103 into Phase 1 provides an opportunity to test its oral peptide delivery technology with a second candidate and explore the potential of combining amylin and GLP-1 mechanisms.

The company is now advancing the clinical development programme, with further data expected to determine whether the once-weekly oral approach can progress into later-stage trials.