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Kymera Therapeutics Announces Positive Interim Results from Single Ascending Dose Phase 1 Trial of KT-474 Demonstrating Degrader Proof-of-Mechanism
KT-474 has achieved and exceeded Phase 1 target degradation of 85% within the SAD portion of the Phase 1 trial dosed to date, with 90% median degradation at
About this update from Kymera Therapeutics, Inc.
[{"type":"text","content":"KT-474 has achieved and exceeded Phase 1 target degradation of 85% within the SAD portion of the Phase 1 trial dosed to date, with 90% median degradation at the 300 mg dose After single dose administration, degradation was maintained for at least six days at all dose levels, with no treatment-related adverse events observed to date Data represent the first proof-of-mechanism for targeted protein degradation in a randomized, placebo-controlled healthy volunteer study FDA has lifted partial clinical hold on Multiple Ascending Dose portion of Phase 1 trial and Kymera plans to initiate repeat dosing in July 2021 Kymera to host conference call today at 8 a.m. ET WATERTOWN, Mass., June 28, 2021 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced positive interim results from the Single Ascending Dose (SAD) portion of the Phase 1 clinical trial of KT-474, demonstrating the first degrader proof-of-mechanism in targeted protein degradation in a randomized, placebo-controlled healthy volunteer study. KT-474 has achieved and exceeded the Phase 1 target degradation of 85% within the SAD portion of the Phase 1 trial dosed to date, with profound IRAK4 degradation after a single oral dose that lasted for at least six days at all dose levels. The partial clinical hold on the Multiple Ascending Dose (MAD) portion of the Phase 1 trial of KT-474 has been lifted following review by the U.S. Food and Drug Administration (FDA) of interim safety, pharmacokinetic and pharmacodynamic data from the first three cohorts of the SAD healthy volunteer portion of the Phase 1 study. In the SAD portion of the trial, healthy volunteer subjects are randomized 6:2 to either a single oral dose of KT-474 or placebo. Interim data (n=32), which also include results from the fourth cohort of the trial, showed dose and time-dependent IRAK4 degradation following single oral KT-474 dose administration (KT-474 dose levels of 25, 75, 150 and 300 mg). IRAK4 levels were measured in peripheral blood mononuclear cells (PBMC) using mass spectrometry. Following a single KT-474 oral dose, IRAK4 reduction was observed as early as eight hours post-dose, reached maximal reduction at 48 to 72 hours, and was sustained for...