TRB-061 / TRex Bio - LARVOL DELTA

Results from the single-ascending-dose (SAD) portion of the Phase 1 study of TRB‑061 — a novel, selective TNFR2 agonist (EADV 2026) - No abstract available

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology

TRexBio Announces Positive Topline Results from First-in-Human Phase 1a Study of TRB-061, a TNFR2 Agonist in Clinical Development for Atopic Dermatitis (Businesswire) - "Across the single ('SAD') and multiple ('MAD') ascending dose cohorts, TRB-061 was generally well tolerated and showed consistent pharmacokinetics. In addition, following single and multiple dose administration of TRB-061, selective, reproducible activation and expansion of exploratory biomarkers including regulatory T cells ('Tregs') was observed, supporting proof of mechanism and dose selection for the ongoing Phase 1b trial in patients with moderate-to-severe atopic dermatitis....The combined safety, PK, and PD results support selection of the 24 and 50 mg dose levels being evaluated in the ongoing Phase 1b portion of the trial....Topline results are expected in mid-2027."

First-in-human • P1 data • Atopic Dermatitis

Tissue Treg reprogramming identifies TNFR2 as a therapeutic target in Atopic Dermatitis (SID 2026) - "In non-human primates, TRB-061, a novel TNFR2 agonist, induced selective pharmacodynamic expansion of tissue-licensed effector Tregs. These findings identify TNFR2 as a regulator of tissue Treg reprogramming in AD and support selective TNFR2 agonism as a strategy to restore immune homeostasis in inflammatory skin disease."

Late-breaking abstract • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

TRexBio Doses First Patient with Moderate-to-Severe Atopic Dermatitis in Phase 1b Clinical Trial of TRB-061, a TNFR2 Agonist (Businesswire) - "The Phase 1b portion of the clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate TRB-061 subcutaneously administered in patients with moderate-to-severe AD. The study will assess safety and tolerability as primary endpoints, with pharmacokinetics and immunogenicity as secondary endpoints....The study is expected to enroll approximately 50 participants with data anticipated in the first half of 2027."

P1 data • Trial status • Atopic Dermatitis • Immunology

Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients (clinicaltrials.gov) - P1 | N=115 | Recruiting | Sponsor: TRex Bio, Inc. | Trial completion date: Jun 2027 ➔ Feb 2028 | Trial primary completion date: Jul 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients (clinicaltrials.gov) - P1 | N=115 | Recruiting | Sponsor: TRex Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

TRexBio Doses First Participant in Phase 1 Trial of TRB-061, a Novel TNFR2 Agonist for Atopic Dermatitis and Other Inflammatory Diseases (Businesswire) - "TRex Bio...announced that it has initiated dosing of healthy volunteers in its first clinical trial for TRB-061, a novel TNFR2 agonist initially being developed for the treatment of atopic dermatitis (AD)....The randomized, double-blind, placebo-controlled Phase 1a study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of TRB-061 administered subcutaneously in healthy adult volunteers (Clinicaltrials.gov Identifier: NCT06934252). The study includes assessments of blood-based biomarkers to establish early proof of mechanism. Following completion of the Phase 1a study, TRexBio plans to initiate a Phase 1b proof-of-concept trial in patients with moderate-to-severe AD....Safety, pharmacokinetic, and pharmacodynamic data from healthy volunteers anticipated in 1H 2026."

P1 data • Trial status • Atopic Dermatitis

Phase 1a/1b Study of TRB-061 in Healthy Participants & Atopic Dermatitis Patients (clinicaltrials.gov) - P1 | N=115 | Not yet recruiting | Sponsor: TRex Bio, Inc.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

TRexBio Announces $84 Million Series B Financing to Advance Pipeline of First-in-Class Immunology Programs into Clinical Development (Businesswire) - "Proceeds from the financing will be used to advance TRexBio’s lead candidate, TRB-061, a purpose-engineered TNFR2 agonist, through early clinical proof of concept in patients with immune mediated diseases including atopic dermatitis and ulcerative colitis....TRexBio expects to initiate a Phase 1 clinical trial with TRB-061 in the first half of 2025. The funding will also support the expansion of TRexBio’s pipeline, including early development of therapeutic candidate TRB-071."

Financing • New P1 trial • Pipeline update • Atopic Dermatitis • Ulcerative Colitis

TRexBio Announces Collaboration Partner Lilly Has Initiated a Phase 1 Study of TRB-051 for Autoimmune and Inflammatory Diseases (Businesswire) - "TRex Bio, Inc...announced that collaboration partner Eli Lilly and Company ('Lilly') has initiated a Phase 1 first-in-human study of TRB-051, a modulator of immune effector cells, for treatment of autoimmune and inflammatory diseases. The program is one of three under the research collaboration and exclusive worldwide license agreement between TRexBio and Lilly, which leverages TRexBio’s proprietary Deep Biology platform to identify and develop novel therapies for the treatment of immune-mediated diseases. Pursuant to the agreement, TRexBio has earned a double-digit million dollar milestone payment and is eligible to receive more than $1.1 billion on achievement of certain development, regulatory, and commercial milestones across partnered programs....TRB-061 is currently in IND enabling studies, and the company anticipates advancing the program into the clinic in the first half of 2025."

New trial • Trial status • Immunology