Latest news with #KT-621BroADen
Yahoo
02-06-2025
- Business
- Yahoo
Kymera Therapeutics Says Atopic Dermatitis Potential Matches Sanofi/Regeneron's Blockbuster Dupixent In Early Biomarker Response
Kymera Therapeutics, Inc. (NASDAQ: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 (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 (NASDAQ:SNY)/Regeneron Pharmaceuticals Inc's (NASDAQ: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. Read Next:Photo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Kymera Therapeutics Says Atopic Dermatitis Potential Matches Sanofi/Regeneron's Blockbuster Dupixent In Early Biomarker Response originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
19-05-2025
- Business
- Yahoo
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, 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-621KT-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 TherapeuticsKymera 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 or follow us on X or LinkedIn. Availability of Other Information About Kymera TherapeuticsFor more information, please visit the Kymera website at 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 StatementsThis 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 KoenigsbergVice President, Investor Relationsinvestors@ 857-285-5300Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
