Kymera Therapeutics NASDAQ: KYMR said it completed enrollment in its Phase 2b atopic dermatitis trial of KT-621 about six months ahead of schedule, positioning the company to report top-line data by the end of 2026 and potentially begin Phase 3 development around mid-2027.
Chief Executive Officer Nello Mainolfi said the accelerated enrollment reflected investigator and patient interest in a once-daily oral treatment, as well as the company’s clinical execution. The placebo-controlled BROADEN2 study is evaluating three doses of KT-621, a STAT6 degrader, in atopic dermatitis. The primary endpoint is the percentage change from baseline in EASI score at week 16, while secondary measures include EASI-50, EASI-75, Investigator’s Global Assessment, pruritus scores and safety.
Mainolfi said the company sought to maintain trial quality and enroll patients with appropriate disease severity despite the faster-than-expected recruitment. He said Kymera expects its results to fall “in that ballpark” of prior dupilumab atopic dermatitis studies, while noting that differences in trial populations make direct comparisons difficult.
KT-621 Programs Advance in Atopic Dermatitis and Asthma
Kymera is developing KT-621 as an oral therapy for Type 2 inflammatory diseases, including atopic dermatitis, asthma, eosinophilic esophagitis, chronic spontaneous urticaria and other conditions. Mainolfi said the company sees an opportunity for an oral medicine that combines clinical activity with tolerability, particularly among patients who are not well served by existing treatments.
The company said enrollment is also underway in the BREADTH Phase 2b trial of KT-621 in Type 2 asthma, with top-line data expected in late 2027. Kymera has initiated an open-label extension study that will allow patients completing BREADTH to continue receiving KT-621 for up to 52 additional weeks.
Mainolfi said asthma recruitment is progressing well but is not expected to match the pace of enrollment in atopic dermatitis. The asthma study has more specific entry requirements, including criteria related to fractional exhaled nitric oxide and eosinophil levels, narrowing the eligible patient population and potentially increasing screen failures.
During the question-and-answer session, Mainolfi said Kymera expects to hold an end-of-Phase 2 meeting with the FDA for atopic dermatitis as soon as possible after the Phase 2b data are available. The company does not intend to wait for the asthma study results before seeking that meeting.
Kymera is also considering pediatric development. The atopic dermatitis study includes adolescents ages 12 and older, and Mainolfi said the company is preparing for studies in younger patients, subject to discussions with regulators. He said the company believes it is in a favorable position from a formulation perspective but did not provide further details.
IRF5 Program Targets Lupus and Other Autoimmune Diseases
Kymera’s second wholly owned clinical program, KT-579, is an oral IRF5 degrader being studied in healthy volunteers. The company expects to report Phase 1 results in the fourth quarter of 2026 and plans to move into a lupus proof-of-concept study shortly afterward.
Mainolfi described IRF5 as a genetically supported regulator of innate immune dysfunction that is implicated in lupus, inflammatory bowel disease and other autoimmune diseases. The Phase 1 trial is designed to assess single and multiple ascending doses, with an objective of achieving more than 90% degradation of IRF5 in blood at doses with a favorable safety profile.
The study will also evaluate pharmacodynamic activity through ex vivo assays measuring the effects of IRF5 degradation on Type 1 interferons, inflammatory cytokines and gene transcripts associated with TLR7, TLR8 and TLR9 pathways. Mainolfi said Kymera expects to see a 50% to 80% reduction in these biomarkers if the program is effectively engaging the target.
New Chief Medical Officer Terence Rooney, a rheumatologist who previously held immunology portfolio leadership roles at Johnson & Johnson, said lupus continues to have substantial unmet need, including for oral medicines with a favorable benefit-risk profile. He said patient selection, site selection, trial design and oversight will be central considerations in lupus development.
Partnered Programs and Leadership Changes
Kymera said Sanofi recently started a Phase 1 study of KT-485, its second-generation IRAK4 degrader, triggering a $20 million milestone payment. The study is designed to evaluate the drug in healthy volunteers and patients with hidradenitis suppurativa.
Meanwhile, KT-200, a CDK2 molecular glue partnered with Gilead Sciences, is advancing toward an expected investigational new drug application and clinical start in 2027, according to the company.
The company also announced leadership changes. Jared Gollob retired as chief medical officer after eight years at Kymera and will remain an adviser through year-end to support the transition. Rooney has succeeded him as CMO. Kymera also named Felix Baker chairman, succeeding Bruce Booth, who will remain on the board as a director.
Second-Quarter Financial Results and Cash Runway
Chief Financial Officer Bruce Jacobs reported second-quarter collaboration revenue of $65 million, consisting of a $45 million option exercise fee tied to Gilead and the $20 million Sanofi milestone. Kymera said it has recognized all deferred revenue and does not expect additional revenue in 2026 unless new collaboration milestones are achieved.
- Research and development expense was $119.5 million, including $10.4 million in non-cash stock-based compensation.
- Adjusted cash R&D expense was $109.1 million, up 22% from the first quarter, reflecting investment in the clinical portfolio.
- General and administrative expense was $21.1 million, including $8.6 million in stock-based compensation.
- Adjusted cash G&A expense was $12.5 million, down 4% sequentially.
- Cash, cash equivalents and investments totaled about $1.5 billion at the end of June.
Jacobs said Kymera’s cash runway extends into 2029 and is expected to support completion of the ongoing KT-621 Phase 2b trials, progression of KT-579 through its planned lupus proof-of-concept study, and initial portions of Phase 3 development for KT-621 in asthma and atopic dermatitis.
About Kymera Therapeutics (NASDAQ:KYMR)
Kymera Therapeutics, Inc is a clinical‐stage biopharmaceutical company headquartered in Watertown, Massachusetts, focused on the discovery, development and commercialization of small‐molecule therapies that harness the body's natural protein homeostasis pathways. Since its founding in 2016, Kymera has pursued a targeted protein degradation platform designed to identify and selectively eliminate disease‐causing proteins. The company's proprietary Pegasus™ platform integrates insights from ubiquitin biology and medicinal chemistry to advance novel degrader candidates across a range of therapeutic areas.
The company's pipeline emphasizes immunology and oncology.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.
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