KT-579 / Kymera Therap - LARVOL DELTA

Firts-in-Class Oral IR5 Degrader, KT-579, Demonstrates Selective and Potent In vitro and In vivo Activity in Human Cellular Assays and Mouse Models of Lupus (EULAR 2026) - No abstract available

Preclinical • Immunology • Inflammatory Arthritis • Lupus

In February 2026, the Company, after IND-clearance from the FDA, commenced dosing in the first-in-human KT-579 Phase 1 clinical trial in healthy volunteers. (GlobeNewswire) - "The Phase 1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of orally administered KT-579 compared to placebo. The key study aim is to show that KT-579 can robustly degrade IRF5 in blood at doses that are safe and well-tolerated. The functional impact of IRF5 degradation on the induction of Type I interferons, proinflammatory cytokines, and inflammatory pathway gene transcripts by TLR 7/8/9 agonists will also be assessed with whole blood ex vivo stimulation assays. The Company expects to report data from the trial in the second half of 2026."

First-in-human • IND • P1 data • Trial status • Immunology

First-in-human Study of Orally Administered KT-579 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Kymera Therapeutics, Inc.

First-in-human • New P1 trial

Kymera Therapeutics Outlines Key 2026 Objectives... (The Manila Times) - "Key Upcoming KT-579 Milestones: Initiate the first-in-human Phase 1 healthy volunteer trial in the first quarter of 2026, with data expected to be reported in the second half of 2026...KT-485/SAR447971, a selective, potent, oral IRAK4 degrader, is being advanced in collaboration with Sanofi for immuno-inflammatory diseases, with a Phase 1 clinical trial expected to initiate in 2026....The Company intends to advance at least one new development candidate towards IND for a first-in-class, oral immunology program in 2026."

First-in-human • New P1 trial • P1 data • Pipeline update • Immunology • Inflammation

Kymera Therapeutics Presents New Preclinical Data for KT-579, a First-in-Class, Oral IRF5 Degrader, at the American College of Rheumatology Annual Meeting (GlobeNewswire) - "The findings show that by selectively targeting and degrading IRF5, a master regulator of immune responses, KT-579 offers a novel oral approach to suppress multiple pro-inflammatory pathways implicated in diseases such as lupus and rheumatoid arthritis (RA)....The Company intends to initiate Phase 1 testing for KT-579 in early 2026."

New P1 trial • Preclinical • Lupus • Rheumatoid Arthritis

Potent and Selective Oral IRF5 Degrader, KT 579, Blocks Pro-Inflammatory Cytokines and Reduces Joint Swelling in a Mouse Model of Rheumatoid Arthritis (ACR Convergence 2025) - "KT-579 was tested in the antigen-induced arthritis (AIA) mouse model of RA and compared to the JAK inhibitor, tofacitinib. We report here the first selective, potent, oral IRF5 degrader that can sufficiently deplete IRF5 and impact myeloid cell effector function by potently inhibiting pro-inflammatory cytokines found to be critical in amplifying inflammatory responses, including cytokines that promote Th1 and Th17 T cell responses, and can reduce joint swelling in a mouse model of RA. These findings support KT-579 as a novel therapeutic agent with the potential to be a first-in-class oral therapy for the treatment of RA and other autoimmune diseases."

Preclinical • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • Targeted Protein Degradation • CXCL1 • IL12A • IL1B • IL23A • IL6 • IRF5 • TLR4 • TLR7 • TLR8 • TNFA

Potent and Selective Oral IRF5 Degrader, KT-579, Demonstrates In Vitro and In Vivo Activity Comparable or Superior to Approved or Clinically Active Agents in Human Cellular Assays and Lupus Efficacy Models (ACR Convergence 2025) - "We report here the first potent, selective, oral IRF5 degrader development candidate, KT-579, which depletes IRF5 in human primary cells, SLE patient derived cells, and lupus disease models, demonstrating superior activity to existing standards of care agents. These findings position KT-579 as a novel, first-in-class, oral therapeutic agent with the potential to transform the treatment landscape of lupus and multiple autoimmune diseases driven by IRF5 dysregulation."

Preclinical • Immunology • Inflammatory Arthritis • Lupus • Renal Disease • Targeted Protein Degradation • IL12A • IL23A • IL6 • IRF5 • TLR7 • TLR8 • TLR9 • TNFA

Kymera Therapeutics Announces Second Quarter 2025 Financial Results and Provides a Business Update (The Manila Times) - "KT-579 IND-enabling studies are ongoing. The Company intends to advance the program into Phase 1 testing in early 2026. Additional new data from preclinical animal models in lupus and RA will be shared in two posters at the American College of Rheumatology (ACR) Annual Meeting..."

New P1 trial • Preclinical • Lupus • Rheumatoid Arthritis

Kymera Therapeutics Expands Industry Leading Immunology Pipeline with New First-in-Class, Oral IRF5 Degrader Program with Potential to Address Multiple Immuno-Inflammatory Diseases (GlobeNewswire) - "KT-579, a potent, selective, oral degrader of IRF5 with an excellent profile in preclinical safety studies, has demonstrated activity comparable or superior to approved and clinically active drugs in multiple efficacy animal models of lupus and RA; IND-enabling studies are ongoing with Phase 1 testing expected to begin in early 2026."

New P1 trial • Preclinical • Immunology • Lupus • Rheumatoid Arthritis