| Item 7.01 | Regulation FD Disclosure. |
On June 28, 2021, Kymera Therapeutics, Inc. (the “Company”) issued a press release, a copy of which is furnished herewith as Exhibit 99.1. In addition, on June 28, 2021, the Company intends to host a conference call to discuss the Company’s ongoing Phase 1 trial of KT-474. A form of the slide presentation that will be used at these meetings is being furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.2.
The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
On June 28, 2021, the Company announced the U.S. Food and Drug Administration (“FDA”), lifted the partial clinical hold on the Company’s ongoing Phase 1 trial of KT-474 following review of interim results from the single ascending dose (“SAD”) portion of the Phase 1 trial. It also announced interim results from the healthy volunteer SAD portion of the Phase 1 trial, including safety, pharmacokinetic, and pharmacodynamic data from the first four study cohorts. Interim data showed dose and time-dependent IRAK4 degradation, as 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).
Table: Percent IRAK4 Change from Baseline in PBMC at 48 Hours Post-Dose using Mass Spectrometry
| | | | | | | | | | |
| | | Placebo
(n=8) | | Cohort 1
(n=6) | | Cohort 2
(n=6) | | Cohort 3
(n=6) | | Cohort 4
(n=6) |
KT-474 dose | | — | | 25 mg | | 75 mg | | 150 mg | | 300 mg |
Median IRAK4 Change | | +16% | | -41%
(p=0.0057) | | -71%
(p<0.0001) | | -78%
(p<0.0001) | | -90%
(p<0.0001) |
No treatment-related adverse events have been observed to date.
The disclosure under this Item 8.01 contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the Company’s views on KT-474 as validating its platform and approach to drug development; strategy, business plans and objectives for its IRAK4 degrader program; and plans and timelines for the clinical development of its product candidates, including the therapeutic potential and clinical benefits thereof. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release,
