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Parvus Therapeutics Announces FDA Clearance of Investigational New Drug Application for PVT201

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 that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for PVT201. With this clearance, Parvus may proceed with a multiple-dose clinical study of PVT201 in the United States.

In a completed first-in-human study conducted in Australia, PVT201 demonstrated favorable safety and tolerability, as expected pharmacokinetics, and pharmacodynamic activity exclusive to target antigen-specific T-cells. A next, multiple-dose, proof-of-concept clinical study in patients with primary biliary cholangitis (PBC) is planned to start in 2027.

PBC is a chronic, progressive autoimmune disease of the liver that can advance to cirrhosis, liver transplant, and death. Current treatments do not address the underlying autoimmune cause of the disease. PVT201 holds FDA Orphan Drug Designation for the treatment of PBC.

“The initial PVT201 clinical study showed that PVT201 induces incipient pharmacodynamic effects on target T-cells,” said Pere Santamaria., MD, PhD, Founder and Chief Scientific Officer of Parvus Therapeutics. “Repeat dosing in patients is the next step as this will show whether we can build on that effect to generate the Treg cells needed to restore immune tolerance in the liver to create a clinical benefit.”

“FDA clearance of the PVT201 IND is a major regulatory milestone for our lead program and for the peptide-MHC nanomedicine platform,” said Peter Strumph, Chief Executive Officer of Parvus Therapeutics. “With PVT201 and PVT401 both in clinical development, we are making progress towards our goal to develop therapies that treat the cause of autoimmune disease without broad immunosuppression.”

About PVT201

Parvus retains all rights to PVT201, the Parvus lead peptide-MHC nanomedicine drug candidate, which is being developed for the treatment of autoimmune liver disease (primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis) and prevention of organ transplant rejection. In a completed first-in-human study, PVT201 demonstrated favorable safety and tolerability, predicted pharmacokinetics, and incipient 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 consist of multiple copies of a disease-specific pMHC conjugated to a nanoparticle. The company's proprietary pMHC nanomedicine platform triggers in vivo differentiation of the patient's own autoreactive T-cells into antigen-specific Treg cells that home to 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 and has demonstrated favorable safety, pharmacokinetics, and incipient on-target pharmacodynamic activity in a Phase 1 first-in-human study. PVT401, being developed in partnership with AbbVie, targets inflammatory bowel disease and is in a Phase 1 clinical trial. Additional pMHC nanomedicine programs address type 1 diabetes, multiple sclerosis, celiac disease, and rheumatoid arthritis.

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