Parvus Therapeutics Initiates First-in-Human Clinical Trial of PVT401 for Inflammatory Bowel Disease
PVT401, a peptide-MHC nanomedicine, is the second Parvus drug candidate to enter clinical trials.
South San Francisco, CA, April 30, 2026 --(PR.com)-- Parvus Therapeutics, a clinical-stage biotechnology company pioneering in vivo generation of precision antigen-specific regulatory T (Treg) cell therapy for autoimmune disease, today announced the successful dosing of the first subject in a Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) clinical trial evaluating PVT401. PVT401, a peptide-major histocompatibility complex (pMHC) nanomedicine candidate, is being developed in partnership with AbbVie to treat inflammatory bowel disease. The study, conducted in Australia, is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PVT401.
"Inflammatory bowel disease represents a large and underserved patient population where existing therapies manage symptoms but do not address the underlying autoimmune pathology,” said Hugh Young Rienhoff, Jr., MD, Executive Chairman and Chief Medical Officer of Parvus Therapeutics. “PVT401 is designed to do something fundamentally different — restore immune tolerance at the site of disease.”
“Initiating the first-in-human study with PVT401 marks a major development milestone for the pipeline of products based on our peptide-MHC nanomedicine platform,” said Peter Strumph, Chief Executive Officer of Parvus Therapeutics. “With two drug candidates, PVT401 and PVT201, in the clinic, we are accumulating evidence that our in vivo Treg cell therapy approach can deliver the disease-specific immune tolerance that patients with autoimmune disease need.”
About PVT401
PVT401, being developed in partnership with AbbVie, is a peptide-MHC nanomedicine drug candidate being developed for the treatment of inflammatory bowel disease.
About PVT201
Parvus retains all rights to PVT201, the Parvus lead peptide-MHC nanomedicine drug candidate being developed for the treatment autoimmune liver disease (primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis) and organ transplant rejection. In the recently completed first-in-human study, PVT201 demonstrated favorable safety and tolerability, predicted pharmacokinetics, and pharmacodynamic activity exclusive to target antigen-specific T-cells.
About Parvus Therapeutics
Parvus Therapeutics is a clinical-stage biotechnology company pioneering in vivo generation of antigen-specific Treg cell therapy to treat and potentially cure autoimmune disease. Parvus pMHC nanomedicines consists of multiple copies of a disease-specific pMHC conjugated to an iron-dextran nanoparticle. The proprietary pMHC nanomedicine platform the company has pioneered trigger in vivo differentiation of the patients own autoreactive T-cells into antigen-specific Treg cells that home to target sites of inflammation and restore local immune tolerance without broad immunosuppression. The Parvus lead drug candidate, PVT201, targets autoimmune liver disease and organ transplant rejection has demonstrated favorable safety, pharmacokinetics, and on-target pharmacodynamic activity in a Phase 1 first-in-human study. PVT401, being developed in partnership with AbbVie, targets inflammatory bowel disease and has entered clinical evaluation. Additional pMHC nanomedicine programs address type 1 diabetes, multiple sclerosis, celiac disease, and rheumatoid arthritis.
"Inflammatory bowel disease represents a large and underserved patient population where existing therapies manage symptoms but do not address the underlying autoimmune pathology,” said Hugh Young Rienhoff, Jr., MD, Executive Chairman and Chief Medical Officer of Parvus Therapeutics. “PVT401 is designed to do something fundamentally different — restore immune tolerance at the site of disease.”
“Initiating the first-in-human study with PVT401 marks a major development milestone for the pipeline of products based on our peptide-MHC nanomedicine platform,” said Peter Strumph, Chief Executive Officer of Parvus Therapeutics. “With two drug candidates, PVT401 and PVT201, in the clinic, we are accumulating evidence that our in vivo Treg cell therapy approach can deliver the disease-specific immune tolerance that patients with autoimmune disease need.”
About PVT401
PVT401, being developed in partnership with AbbVie, is a peptide-MHC nanomedicine drug candidate being developed for the treatment of inflammatory bowel disease.
About PVT201
Parvus retains all rights to PVT201, the Parvus lead peptide-MHC nanomedicine drug candidate being developed for the treatment autoimmune liver disease (primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis) and organ transplant rejection. In the recently completed first-in-human study, PVT201 demonstrated favorable safety and tolerability, predicted pharmacokinetics, and pharmacodynamic activity exclusive to target antigen-specific T-cells.
About Parvus Therapeutics
Parvus Therapeutics is a clinical-stage biotechnology company pioneering in vivo generation of antigen-specific Treg cell therapy to treat and potentially cure autoimmune disease. Parvus pMHC nanomedicines consists of multiple copies of a disease-specific pMHC conjugated to an iron-dextran nanoparticle. The proprietary pMHC nanomedicine platform the company has pioneered trigger in vivo differentiation of the patients own autoreactive T-cells into antigen-specific Treg cells that home to target sites of inflammation and restore local immune tolerance without broad immunosuppression. The Parvus lead drug candidate, PVT201, targets autoimmune liver disease and organ transplant rejection has demonstrated favorable safety, pharmacokinetics, and on-target pharmacodynamic activity in a Phase 1 first-in-human study. PVT401, being developed in partnership with AbbVie, targets inflammatory bowel disease and has entered clinical evaluation. Additional pMHC nanomedicine programs address type 1 diabetes, multiple sclerosis, celiac disease, and rheumatoid arthritis.
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Parvus Therapeutics U.S., Inc.
Jord Cowan
1-403-708-3401
www.parvustx.com
Jord Cowan
1-403-708-3401
www.parvustx.com
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