Kymera Therapeutics Says Atopic Dermatitis Potential Matches Sanofi/Regeneron's Blockbuster Dupixent In Early Biomarker Response

Kymera Therapeutics, Inc. KYMR on Monday revealed clinical results from the Phase 1 healthy volunteer study of KT-621, its first-in-class, oral STAT6 degrader medicine.

The findings significantly surpassed the company’s expectations, demonstrating robust STAT6 degradation and a favorable safety profile, thereby derisking the program, the company said in a press release.

Pharmacokinetics (PK):

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 a steady state was achieved by Day 4.

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Pharmacodynamics (PD):

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.

STAT6 levels in blood and skin were measured. Complete degradation within a cohort is defined as either a mean reduction of ≥95% or, when most subjects’ STAT6 levels are reduced below the Lower Limit of Quantification (LLOQ), or both.

In SAD, maximal degradation was achieved in blood as quickly as the first collected timepoint of 4 hours after a single dose, with mean STAT6 degradation reaching >90% across all SAD doses starting at 6.25 mg.

All SAD cohorts at 75 mg or greater doses achieved >95% mean STAT6 degradation with STAT6 levels below LLOQ in multiple subjects.

In MAD, STAT6 degradation was observed in blood at the first timepoint measured (8 hours) for doses above 1.5 mg.

Steady-state, complete degradation, associated with STAT6 reductions below the LLOQ in the majority of subjects, was achieved at doses ≥50 mg, with recovery starting as early as 4 days after the last dose.

In MAD, robust STAT6 degradation was observed in the skin at the first timepoint measured (Day 7) for doses above 1.5 mg.

Steady-state, complete degradation, associated with ≥95% mean STAT6 degradation with STAT6 levels below LLOQ in multiple subjects, was achieved at doses ≥50 mg.

Th2 Biomarkers:

TARC reduction was observed for all KT-621 dose groups, with a median reduction of up to 37% at Day 14.

The company says the results are comparable or superior to what was seen in the Sanofi SA SNY/Regeneron Pharmaceuticals Inc’s REGN Dupixent (dupilumab) healthy volunteer study.

The safety profile of KT-621 was undifferentiated from that of the placebo.

The company’s KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis patients is ongoing, with data expected to be reported in the fourth quarter of 2025.

Two parallel Phase 2b trials in atopic dermatitis and asthma will start in 4Q25 and 1Q26, respectively.

Price Action: KYMR stock was trading higher by 30.2% to $38.58 at last check Monday.

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