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Kymera Therapeutics (KYMR) Announces Interim Results from Single Ascending Dose Phase 1 Trial of KT-474 in targeted protein degradation
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Additional Information
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 at least six days with subsequent recovery towards pre-treatment baseline across all dose groups. In the fourth cohort, following a single 300 mg dose of KT-474, median IRAK4 reduction from baseline at 48 hours was 90% compared to a 16% increase in the placebo group (p<0.0001), with maximum IRAK4 reduction of 94%, demonstrating proof-of-mechanism for KT-474 (see table below). KT-474, to date, has demonstrated oral bioavailability, predictable and dose-dependent plasma exposures, and a half-life supportive of oral daily dosing. No treatment-related adverse events have been observed to date.
“This study marks the first time a heterobifunctional small molecule degrader has been studied in humans in a placebo-controlled study,” said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics. “We have shown that KT-474 can lead to rapid, marked and sustained IRAK4 reduction after a single dose. The ability to reach and sustain biologically relevant levels of target degradation after just a single dose not only validates Kymera’s platform, but importantly, further de-risks the development of KT-474 as a potentially best-in-class anti-inflammatory oral agent.”
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Catalyst Date
Occurred on:
Jun 28, 2021
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Related Keywords
Kt-474, Targeted Protein Degradation, Irak-4
