Parvus Therapeutics Reports Positive Phase 1 Results for Lead Autoimmune Treg Therapy, PVT201
PVT201 demonstrated favorable safety, predictable pharmacokinetics, and on-target pharmacodynamic activity in first-in-human study.
South San Francisco, CA, November 12, 2025 --(PR.com)-- Parvus Therapeutics, a clinical-stage biotechnology company pioneering in vivo precision antigen-specific regulatory T (Treg) cell therapy for autoimmune disease, today announced positive results from its first-in-human (FIH) Phase 1 single ascending dose (SAD) study evaluating its lead peptide–major histocompatibility complex (pMHC) nanomedicine drug candidate, PVT201.
The randomized, placebo-controlled study enrolled 24 healthy volunteers, with 16 participants receiving escalating single doses of PVT201 and 8 receiving placebo. PVT201 was safe and well tolerated across all dose levels, with no serious adverse events and no clinically meaningful changes in vital signs, ECGs, or laboratory parameters. Pharmacokinetic (PK) results confirmed the PK predicted from nonclinical models. Importantly, post-dose increases in the expression of pre-selected markers exclusively on antigen-specific T-cells provided clear evidence of in vivo differentiation of antigen-specific autoreactive T-cells into Treg cells.
“The results demonstrate safety, tolerability, and pharmacokinetics consonant with our preclinical models. We also observed clear evidence that this type of drug will provide the specificity needed to induce antigen-experienced T-cells to become Tregs. This is a remarkable observation given this is a single dose study.” said Dr. Hugh Young Rienhoff, Jr., Executive Chairman and Chief Medical Officer of Parvus Therapeutics.
Parvus is planning to initiate a multiple-ascending-dose (MAD) study of PVT201 in patients with primary biliary cholangitis (PBC) next year. In parallel, Parvus is preparing for a first-in-human SAD/MAD study of PVT401, its second Navacim drug candidate being developed in partnership with AbbVie for the treatment of inflammatory bowel disease.
“This is an exciting moment for Parvus and for the field of Treg immunotherapy,” said Peter Strumph, CEO of Parvus Therapeutics. “Results from this first-in-human experience represents a significant development milestone and bring us closer to providing breakthrough therapy to patients who suffer from autoimmune disease.”
About Parvus Therapeutics
Parvus Therapeutics is a clinical-stage biotechnology company pioneering in vivo precision antigen-specific Treg cell therapy to treat and potentially cure autoimmune disease. The company’s proprietary pMHC nanomedicine platform reprograms the immune system by triggering in vivo differentiation of autoreactive T-cells into Treg cells, restoring immune tolerance without broad immunosuppression.
Parvus’ lead candidate, PVT201, targets autoimmune liver disease, while PVT401, partnered with AbbVie, is advancing toward clinical evaluation in inflammatory bowel disease. Additional pMHC nanomedicine programs address type-1 diabetes, multiple sclerosis, rheumatoid arthritis, celiac disease, and organ transplant rejection.
The randomized, placebo-controlled study enrolled 24 healthy volunteers, with 16 participants receiving escalating single doses of PVT201 and 8 receiving placebo. PVT201 was safe and well tolerated across all dose levels, with no serious adverse events and no clinically meaningful changes in vital signs, ECGs, or laboratory parameters. Pharmacokinetic (PK) results confirmed the PK predicted from nonclinical models. Importantly, post-dose increases in the expression of pre-selected markers exclusively on antigen-specific T-cells provided clear evidence of in vivo differentiation of antigen-specific autoreactive T-cells into Treg cells.
“The results demonstrate safety, tolerability, and pharmacokinetics consonant with our preclinical models. We also observed clear evidence that this type of drug will provide the specificity needed to induce antigen-experienced T-cells to become Tregs. This is a remarkable observation given this is a single dose study.” said Dr. Hugh Young Rienhoff, Jr., Executive Chairman and Chief Medical Officer of Parvus Therapeutics.
Parvus is planning to initiate a multiple-ascending-dose (MAD) study of PVT201 in patients with primary biliary cholangitis (PBC) next year. In parallel, Parvus is preparing for a first-in-human SAD/MAD study of PVT401, its second Navacim drug candidate being developed in partnership with AbbVie for the treatment of inflammatory bowel disease.
“This is an exciting moment for Parvus and for the field of Treg immunotherapy,” said Peter Strumph, CEO of Parvus Therapeutics. “Results from this first-in-human experience represents a significant development milestone and bring us closer to providing breakthrough therapy to patients who suffer from autoimmune disease.”
About Parvus Therapeutics
Parvus Therapeutics is a clinical-stage biotechnology company pioneering in vivo precision antigen-specific Treg cell therapy to treat and potentially cure autoimmune disease. The company’s proprietary pMHC nanomedicine platform reprograms the immune system by triggering in vivo differentiation of autoreactive T-cells into Treg cells, restoring immune tolerance without broad immunosuppression.
Parvus’ lead candidate, PVT201, targets autoimmune liver disease, while PVT401, partnered with AbbVie, is advancing toward clinical evaluation in inflammatory bowel disease. Additional pMHC nanomedicine programs address type-1 diabetes, multiple sclerosis, rheumatoid arthritis, celiac disease, and organ transplant rejection.
Contact
Parvus Therapeutics U.S., Inc.
Jord Cowan
1-403-708-3401
www.parvustx.com
Jord Cowan
1-403-708-3401
www.parvustx.com
Contact
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