Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVT80 · 1 trial · 1 indication
PK endpoint of Cmax.
| Arm | Type | Description |
|---|---|---|
| AVT80 | EXPERIMENTAL | Single subcutaneous administration of AVT80 |
| Geographical region 1 Entyvio | ACTIVE_COMPARATOR | Single subcutaneous administration of Geographical region 1 Entyvio |
| Geographical region 2 Entyvio | ACTIVE_COMPARATOR | Single subcutaneous administration of Geographical region 2 Entyvio |
| Name | Type | Description |
|---|---|---|
| AVT80 | BIOLOGICAL | Single subcutaneous injection of AVT80 (108mg) |
| Geographical region 1 Entyvio | BIOLOGICAL | Single subcutaneous injection of Geographical region 1 Entyvio (108mg) |
| Geographical region 2 Entyvio | BIOLOGICAL | Single subcutaneous injection of Geographical region 2 Entyvio (108mg) |
Inclusion Criteria: * Healthy male and female participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol. * Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index...
AVT80 is an investigational monoclonal antibody developed by Alvotech as a proposed biosimilar to vedolizumab, the active ingredient in Entyvio. It is in Phase 1 clinical development. Alvotech trades on the Nasdaq under the ticker ALVO. The specific therapeutic indications for AVT80 have not been publicly disclosed.
AVT80 targets vedolizumab, a protein target. It is a monoclonal antibody designed as a biosimilar candidate referencing Entyvio, which binds the same target. By matching the reference product's target, AVT80 aims to demonstrate comparable pharmacokinetic and clinical behavior to vedolizumab in the studied population.
AVT80 is developed by Alvotech, a biotechnology company listed on the Nasdaq under the ticker ALVO. Alvotech specializes in the development and manufacture of biosimilar medicines. AVT80 is one of the company's monoclonal antibody biosimilar candidates.
AVT80 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. A single Phase 1 trial has been completed, and no active trials are currently listed for this candidate.
AVT80 has been studied in one completed Phase 1 trial, NCT06732804, titled a study to investigate comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio. The trial enrolled 385 healthy male and female subjects aged 18 years and older in Australia and New Zealand. It was randomized, double blind, and active controlled.
No. AVT80 is an investigational biosimilar candidate referencing Entyvio, which contains vedolizumab. AVT80 is not the same product as Entyvio. The completed Phase 1 trial NCT06732804 compared the pharmacokinetics, safety, immunogenicity and tolerability of AVT80 against Entyvio in healthy volunteers.