Kymera Therapeutics Presents New Preclinical Data for KT-621, a First-In-Class, Oral STAT6 Degrader at the American Thoracic Society International Conference
- KT-621 showed comparable or superior efficacy to dupilumab in preclinical asthma models
- Successfully completed Phase 1 healthy volunteer trials
- Potential to offer oral alternative to injectable treatments
- Multiple clinical trials advancing with Phase 2b trials planned in Q4 2025 and Q1 2026
- First STAT6 targeted medicine to enter clinical development
- Phase 1b and Phase 2b trial results still pending, creating uncertainty about clinical efficacy
- Will face competition from established injectable treatments like dupilumab
Insights
Kymera's oral STAT6 degrader KT-621 shows promising preclinical asthma results comparable to dupilumab, with multiple clinical trials advancing in 2025-2026.
Kymera Therapeutics has shared compelling new preclinical data for KT-621, their first-in-class oral STAT6 degrader at the American Thoracic Society Conference. The results demonstrate this oral medication can both prevent disease progression and reverse established disease in a house dust mite (HDM)-induced chronic asthma mouse model, with activity comparable or superior to dupilumab, an established injectable biologic therapy.
The data is particularly significant as it suggests KT-621 can effectively block Th2 inflammation pathways while improving lung remodeling at low daily oral doses. The medication appears to target the same biological pathway as injectable biologics like dupilumab but offers the convenience of oral administration, which could substantially expand patient access to advanced immunological therapies.
Kymera has completed their Phase 1 healthy volunteer single and multiple ascending dose (SAD/MAD) trial, with complete data coming in June 2025. Their clinical development timeline is clearly defined with: a Phase 1b trial in atopic dermatitis patients ongoing (data expected Q4 2025), a Phase 2b trial in atopic dermatitis planned for Q4 2025, and a Phase 2b trial in asthma set for Q1 2026.
This developmental progress positions KT-621 as potentially the first STAT6-targeted medicine to advance through clinical trials. If successful, this oral therapy could offer a significant advantage over current injectable biologics in treating multiple Th2-driven allergic and atopic conditions, potentially transforming treatment paradigms for millions of patients with asthma and related immunological disorders.
KT-621, a potent, selective, oral STAT6 degrader, demonstrated comparable or superior activity to dupilumab in a newly disclosed preclinical chronic asthma model reversing disease progression
KT-621 Phase 1 healthy volunteer SAD/MAD trial completed with data to be reported in June 2025
KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) ongoing with data expected in 4Q25
Two parallel Phase 2b trials in AD and asthma planned to start in 4Q25 and 1Q26, respectively
WATERTOWN, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, 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.
Additionally, Jared Gollob, MD, Kymera’s Chief Medical Officer, was featured in an oral showcase presentation as part of the ATS Respiratory Innovation Summit (RIS) discussing the Company’s industry-leading oral immunology portfolio, including the KT-621 program.
“We believe KT-621 represents an enormous opportunity to expand patient access to an oral systemic advanced therapy in many common immuno-inflammatory diseases, such as asthma, that have limited or suboptimal treatment options,” said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. “KT-621’s impressive and consistent preclinical data package shows the revolutionary potential of STAT6 degradation to phenocopy the activity of upstream biologics, like dupilumab, while offering the convenience of a once daily oral medicine. These encouraging results in an established and clinically validated asthma mouse model with both a prophylactic and now therapeutic treatment regimen further increase our confidence in the transformative potential of KT-621 as we approach our Phase 2b trial in asthma early next year. We look forward to sharing updates from our KT-621 Phase 1 trials in healthy volunteers next month and atopic dermatitis patients later this year.”
The Company previously demonstrated that KT-621 prevents disease progression in the prophylactic intranasal house dust mite (HDM)-induced model in IL-4/IL-4RA humanized mice. KT-621 robustly inhibited all the tested cytokines, chemokines, cell infiltrates, and lung remodeling involved in Th2 inflammation in asthma to an extent comparable or superior to an IL-4Rα saturating dose of the injectable IL-4Rα antibody, dupilumab, included in the same study. 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. The Company also shared new histology data from the therapeutic efficacy model showing amelioration of lung remodeling, including goblet cell metaplasia and MUC5AC mRNA expression, after low daily oral doses of KT-621 that was superior to dupilumab. Overall, the preclinical data shared to date demonstrate the best-in-pathway potential of KT-621 for the treatment of Th2 allergic and atopic diseases given its dupilumab-like activity profile and the convenience of an oral pill.
The Company has completed the Phase 1 healthy volunteer trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending (SAD/MAD) 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. Additionally, the 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.
Copies of both the ATS and RIS presentations are available in the Resource Library section of Kymera's website.
About KT-621
KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signaling and the central driver of Th2 inflammation. STAT6 degradation has the potential to provide the convenience of an oral medicine with the potential for biologics-like activity and in doing so reach broader patient populations compared to injectable biologics or other standards of care. In preclinical studies, KT-621 demonstrated dupilumab-like activity in several in vitro and in vivo models and was safe and well tolerated. KT-621, the first STAT6 directed medicine to enter clinical evaluation, has the opportunity to transform treatment paradigms for more than 130 million patients around the world, including children and adults, suffering from Th2 diseases such as AD, asthma, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others.
About Kymera Therapeutics
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X or LinkedIn.
Availability of Other Information About Kymera Therapeutics
For more information, please visit the Kymera website at https://www.kymeratx.com/ or follow Kymera on X (@KymeraTx) and LinkedIn (Kymera Therapeutics). Investors and others should note that Kymera communicates with its investors and the public using the Company website, including, but not limited to, corporate disclosures, investor presentations, FAQs, Securities and Exchange Commission (SEC) filings, press releases, public conference call transcripts and webcast transcripts, as well as on X and LinkedIn. The information that Kymera posts on its website or on X or LinkedIn could be deemed to be material information. As a result, the Company encourages investors, the media and others interested to review the information that Kymera posts there on a regular basis. The contents of Kymera’s website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about our expectations regarding strategy, business plans and the progress, timing and objectives on the development of KT-621, including the therapeutic potential, clinical benefits and safety thereof, the advancement in Phase 1 clinical testing. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target," "upcoming" and similar words or 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 any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future trials and the results of such trials, whether preclinical results will be indicative of the results of clinical trials, the ability to successfully demonstrate the safety and efficacy of drug candidates, the timing and outcome of planned interactions with regulatory authorities, the availability of funding sufficient for our operating expenses and capital expenditure requirements and other factors. These risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in the most recent Quarterly Report on Form 10-Q and in subsequent filings with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor and Media Contact:
Justine Koenigsberg
Vice President, Investor Relations
investors@kymeratx.com
media@kymeratx.com
857-285-5300
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