“Years from now, when we tell the Provention Bio story, it won’t just be about financial success, it will be about the impact we have on the patient.”

Andrew Drechsler, Chief Financial Officer, Provention Bio

therapeutic strategy


We have built a carefully selected portfolio of therapeutic candidates that target the interception of autoimmunity to prevent prevalent, chronic, debilitating and life-threatening immune-mediated diseases. Our pipeline spans all stages of development, including a pre-commercial stage therapy for the delay or prevention of the diagnosis of type 1 diabetes (T1D) in individuals at-risk of developing clinical disease.

To learn more about Provention Bio’s clinical trials, please click here.

Focus Indication Pre-Clinical Phase 1 Phase 2 Phase 3 Regulatory Next Expected Milestone

Type 1 Diabetes (T1D) Autoimmunity

At Risk

Newly Diagnosed


Complete BLA filing in Q4 2020

Complete PROTECT enrollment*

Initiate Phase 1 first-in-human trial H2 2020

B-Cell Autoimmunity Checkpoint


Prevention of immunogenicity

Start Phase 2a trial in H1 2021

Preclinical data H2 ’20

GI Autoimmunity

Celiac Disease

Program Partner


Initiate Phase 2b trial Q3 2020

* Enrollment in PROTECT was paused in March 2020 due to the COVID-19 outbreak; during Q2 certain sites in certain countries resumed enrollment of patients