KT-621 / Kymera Therap - LARVOL DELTA

Kymera Therapeutics Announces U.S. FDA Fast Track Designation for KT-621, a First-in-Class, Oral STAT6 Degrader for the Treatment of Atopic Dermatitis (GlobeNewswire) - "Fast Track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis (AD) patient trial."

Fast track • Atopic Dermatitis

Kymera Therapeutics Announces Positive Results from BroADen Phase 1b Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader, in Patients with Moderate to Severe Atopic Dermatitis (GlobeNewswire) - "KT-621 exhibited a plasma PK profile across the 100 mg and 200 mg dose groups consistent with the Phase 1a healthy volunteer trial results...At Day 29, median STAT6 degradation in blood as measured by flow cytometry was 98% at both the 100 mg and 200 mg doses...A validated biomarker of Type 2 inflammation, TARC reductions with KT-621 were robust and highly associated with baseline levels of TARC in treated patients, consistent with reported dupilumab studies across multiple diseases....Mean EASI score reductions at Day 29 were 62% and 63% in the 100 mg and 200 mg dose groups, respectively, and 63% across all patients. KT-621 demonstrated rapid onset of action with measurable EASI impact by Day 8, the earliest timepoint reported."

Biomarker • P1 data • Atopic Dermatitis

Kymera Therapeutics…will announce results from the BroADen Phase 1b clinical trial evaluating KT-621, its oral STAT6 degrader, in patients with moderate to severe atopic dermatitis (AD) on Monday, December 8, 2025 (GlobeNewswire)

P1 data • Atopic Dermatitis

Safety, Pharmacokinetics and Pharmacodynamics of KT-621, an Oral STAT6 Degrader, in Healthy Adults (ISDS 2025) - P1 | "KT-621 had a robust effect on Eotaxin-3, a highly specific chemokine downstream of IL-4/IL-13 pathway activation, with median reduction of up to 63% at Day 14. These data are the first to demonstrate the potential of STAT6 degradation for treatment of Th2 driven diseases such as asthma or eosinophilic COPD."

Clinical • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • STAT6

Kymera Therapeutics Announces First Patient Dosed in BROADEN2 Phase 2b Atopic Dermatitis Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader (GlobeNewswire) - "The Company expects to report data from the BROADEN2 trial by mid-2027. Additionally, the Company previously announced it completed dosing in the KT-621 BroADen Phase 1b trial in AD, with data to be reported in December 2025....The Company is on track to initiate BREADTH, a Phase 2b trial in moderate to severe asthma patients, in the first quarter of 2026."

New P2 trial • P1 data • P2b data • Trial status • Asthma • Atopic Dermatitis • Immunology

STAT6 Degrader Program (GlobeNewswire) - "The Company has completed enrollment and dosing in the KT-621 BroADen Phase 1b trial, an open label study in patients with moderate to severe AD, with data expected to be reported in December 2025...The KT-621 BROADEN2 Phase 2b trial in AD has been initiated with data expected by mid-2027...The Company is on track to initiate BREADTH, a Phase 2b trial in moderate to severe asthma patients, in the first quarter of 2026."

New P2b trial • P1 data • P2b data • Asthma • Atopic Dermatitis • Immunology

BROADEN2: A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Kymera Therapeutics, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

BroADen: Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Kymera Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

First-in-human Study of Orally Administered KT-621 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=118 | Completed | Sponsor: Kymera Therapeutics, Inc. | Recruiting ➔ Completed

First-in-human • Trial completion

Potent and Selective Oral STAT6 Degrader, KT-621, Inhibits IL-4 and IL-13 Functions in Human Cells and Blocks Th2 Inflammation In Vivo in Multiple Preclinical Models of Th2 Diseases (EADV 2025) - "We compared the efficacy of KT-621 to dupilumab in vivo in an MC903 induced atopic dermatitis model and a HDM induced asthma model in the IL-4/IL-4RA humanized mice with a prophylactic regimen. STAT6 degradation is a potential novel oral approach for blocking the IL-4/IL-13 pathways. These data demonstrate the potential of KT-621, the first STAT6-targeted medicine in clinical development, for the treatment of atopic dermatitis and other allergic diseases with best-in-pathway potential given its biologics-like activity profile and oral bioavailability."

Preclinical • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Inflammation • Respiratory Diseases • Targeted Protein Degradation • IL13 • IL4 • IL4R • STAT6

KT-621, an Oral, Once Daily, Targeted STAT6 Degrader: First-in-Human Phase 1a Safety, Pharmacokinetics, Pharmacodynamics and Th2 Biomarker Effects (EADV 2025) - P1 | "KT-621 resulted in robust decreases in TARC and eotaxin-3 comparable to what has been reported with dupilumab in healthy subjects and asthma patients, respectively, thereby confirming IL- 4/13 pathway inhibition. Together, these data demonstrate the potential of KT-621 as a once daily, oral therapy for IL-4/13-mediated diseases such as atopic dermatitis and asthma."

Biomarker • Clinical • First-in-human • Late-breaking abstract • P1 data • PK/PD data • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Respiratory Diseases • Targeted Protein Degradation • IL13 • IL4 • IL4R • STAT6

Late Breaking Abstract - Safety, pharmacokinetics and pharmacodynamics of KT-621, an oral STAT6 degrader, in healthy adults (ERS 2025) - P1 | "KT-621 had a robust effect on Eotaxin-3, a highly specific chemokine downstream of IL-4/IL-13 pathway activation, with median reduction of up to 63% at Day 14. These data are the first to demonstrate the potential of STAT6 degradation for treatment of Th2 driven diseases such as asthma or eosinophilic COPD."

Clinical • Late-breaking abstract • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • STAT6

Kymera Therapeutics Announces Late-Breaking Oral Presentations on KT-621, a First-In-Class, Oral STAT6 Degrader, at the European Academy of Dermatology & Venereology and European Respiratory Society Congresses (GlobeNewswire) - "In the Phase 1 healthy volunteer single- and multiple-ascending dose (SAD/MAD) study presented at EADV and ERS, KT-621 demonstrated rapid, deep and prolonged STAT6 degradation in blood and skin. In blood, >90% mean STAT6 degradation was achieved at all doses above 1.5 mg. Complete STAT6 degradation was achieved in both blood and skin at all MAD doses ≥50 mg."

Late-breaking abstract • P1 data • Atopic Dermatitis

In a preclinical poster presented at EADV, new data show that KT-621 modulated AD-relevant genes in IL-4-stimulated keratinocytes similar to dupilumab. (GlobeNewswire)

Preclinical • Atopic Dermatitis

Business Highlights, Recent Developments and Upcoming Milestones (The Manila Times) - "The Company will present the KT-621 Phase 1 healthy volunteer data in a late-breaking oral presentation at the European Respiratory Society (ERS) Congress....Additionally, the Company will present KT-621 preclinical data in a poster at the European Academy of Dermatology and Venereology (EADV) Congress..."

Late-breaking abstract • P1 data • Preclinical • Atopic Dermatitis

Kymera Therapeutics Announces Second Quarter 2025 Financial Results and Provides a Business Update (The Manila Times) - "The KT-621 BroADen Phase 1b trial, an open label study in patients with moderate to severe AD, is ongoing, with data expected to be reported in the fourth quarter of 2025....Two parallel Phase 2b studies in AD and asthma patients are planned to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively."

New P2b trial • P1 data • Asthma • Atopic Dermatitis

Kymera Therapeutics Announces Positive First-in-Human Results from Phase 1 Healthy Volunteer Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader (GlobeNewswire) - P1 | N=120 | NCT06673667 | Sponsor: Kymera Therapeutics, Inc. | "KT-621 demonstrated a favorable plasma PK profile after single and multiple doses. Rapid absorption was demonstrated with a median tmax of 2-4 hours and a mean half-life of 9-36 hours. There was a dose-proportional increase in exposure after multi-dosing and steady-state was achieved by Day 4...KT-621 demonstrated rapid, deep and prolonged STAT6 degradation in blood after single doses of KT-621 and in blood and skin after multiple doses of KT-621....TARC reduction was observed for all KT-621 dose groups, with median reduction of up to 37% at Day 14...The Company’s KT-621 BroADen Phase 1b trial in moderate to severe AD patients is ongoing, with data expected to be reported in the fourth quarter of 2025. Two parallel Phase 2b trials in AD and asthma are planned to start in 4Q25 and 1Q26, respectively."

New P2b trial • P1 data • PK/PD data • Asthma • Atopic Dermatitis • Dermatology

Kymera Therapeutics to Announce KT-621 Phase 1 Healthy Volunteer Trial Results on June 2, 2025 (GlobeNewswire) - "Kymera Therapeutics...will announce results from the Phase 1 clinical trial evaluating single and multiple-ascending doses of KT-621 in healthy volunteers on Monday, June 2, 2025....KT-621 is currently being evaluated in a Phase 1b trial (BroADen) in atopic dermatitis patients, with data from the study expected to be reported in the fourth quarter of 2025."

P1 data • Atopic Dermatitis

Potent and Selective Oral STAT6 Degrader, KT-621, Inhibits IL-4 and IL-13 Functions in Human Cells and Blocks TH2 Inflammation in a House Dust Mite Model of Asthma (ATS 2025) - "Dupilumab, an injectable monoclonal antibody that blocks IL-4/IL-13 signaling, is an approved therapy for multiple atopic/allergic diseases. STAT6 degradation is a potential novel oral approach for blocking the IL-4/IL-13 signaling pathways involved in TH2 inflammation. These data demonstrate the potential of KT-621 for the treatment of asthma, chronic obstructive pulmonary disease (COPD), and other allergic diseases with best-in-pathway potential given its biologics-like activity profile and oral bioavailability. KT-621 is currently in Phase 1 clinical testing."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • Targeted Protein Degradation • IL13 • IL4 • IL4R • STAT6

Kymera Therapeutics Presents New Preclinical Data for KT-621, a First-In-Class, Oral STAT6 Degrader at the American Thoracic Society International Conference (GlobeNewswire) - "Kymera Therapeutics...today announced the presentation of additional preclinical data for KT-621, its potent, selective, oral STAT6 degrader and the first STAT6 targeted medicine to enter clinical development. The new asthma efficacy mouse model data showed both prevention of disease progression as well as reversal of established disease, building upon the compelling preclinical characterization of KT-621 as a potential once daily, oral treatment for asthma and other Th2 allergic and atopic diseases. These data were presented at the American Thoracic Society (ATS) International Conference being held May 16-21, 2025, in San Francisco, CA...New data shared at ATS show that in the HDM-induced chronic mouse model with a therapeutic treatment regimen, KT-621 administered orally after disease establishment demonstrated comparable or superior activity to dupilumab in blocking Th2 inflammation."

Preclinical • Asthma • Inflammation

Kymera Therapeutics Announces First Quarter 2025 Financial Results and Provides a Business Update (GlobeNewswire) - "In May, the Company made the strategic decision not to advance KT-295, its oral TYK2 degrader, into clinical development, despite completing IND-enabling studies with no adverse findings. This decision will allow Kymera to focus its team and financial resources on other pipeline programs, including KT-621 and KT-579."

Pipeline update • Atopic Dermatitis • Immunology

Kymera Therapeutics Announces First Patient Dosed in BROADEN Phase 1b Atopic Dermatitis Clinical Trial of KT-621, a First-in-Class Oral STAT6 Degrader (GlobeNewswire) - "Kymera Therapeutics, Inc...announced that it recently initiated dosing in its BroADen Phase 1b clinical trial evaluating KT-621, an oral, highly selective, potent degrader of STAT6, in patients with moderate to severe atopic dermatitis (AD). The Company expects to report data from the BroADen trial in the fourth quarter of 2025. Additionally, the Company has completed SAD/MAD dosing and follow-up in the KT-621 Phase 1 healthy volunteer trial with data to be reported in June 2025."

P1 data • Trial status • Atopic Dermatitis

Kymera Therapeutics Announces First Quarter 2025 Financial Results and Provides a Business Update (GlobeNewswire) - "The Company has completed the Phase 1 healthy volunteer trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of KT-621 compared to placebo. In June 2025, Kymera will host a webcast to disclose the complete KT-621 Phase 1 healthy volunteer SAD/MAD data, which will include STAT6 degradation, safety and additional biomarker results; Two parallel Phase 2b studies in AD and asthma patients are planned to begin in the fourth quarter of 2025 and first quarter of 2026, respectively; The Company plans to present additional KT-621 preclinical data at the American Thoracic Society (ATS) Annual Meeting being held May 16-21, 2025, in San Francisco, CA."

New P2b trial • P1 data • Preclinical • Asthma • Atopic Dermatitis

BroADen: Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Kymera Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

BroADen: Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD) (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Kymera Therapeutics, Inc.

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