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Kymera Therapeutics Inc, a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to KT-621, its first-in-class, oral STAT6 degrader, for the treatment of moderate to severe atopic dermatitis.
“Atopic dermatitis is a chronic, debilitating disease. Far too many patients are currently untreated and are looking for new options. Receiving Fast Track designation will allow us to explore ways to accelerate the development of KT-621 and reflects the immense opportunity to advance a first-in-industry oral therapy that could address significant gaps within the current treatment landscape,” said Nello Mainolfi, founder, president and CEO of Kymera Therapeutics. “Our goal with KT-621 is to deliver a once-a-day oral medicine with the activity and safety of injectable biologics, but in a far more convenient format – broadening access and supporting better outcomes for the millions of adults and children affected by atopic dermatitis and other type 2-driven diseases around the world.”
Fast Track designation supported by positive results from the KT-621 BroADen phase 1b atopic dermatitis patient trial.
KT-621 BroADen phase 2b atopic dermatitis trial ongoing, with data expected to be reported by mid-2027 and BREADTH phase 2b trial in asthma on track to initiate in 1Q26.
The company recently reported positive results from the BroADen phase 1b atopic dermatitis trial, in which KT-621 demonstrated the potential to provide a once-daily oral treatment for type 2 inflammatory diseases across every measure evaluated, including STAT6 degradation, biomarker modulation, clinical activity, impact on comorbid Type 2 diseases, and safety.
The KT-621 BroADen phase 2b trial in moderate to severe AD patients is ongoing, with data expected to be reported by mid-2027. The BREADTH phase 2b trial in asthma is planned to start in the first quarter of 2026. These studies are intended to accelerate KT-621 development and enable dose selection for subsequent parallel phase 3 registration studies across multiple type 2 dermatology, gastroenterology and respiratory indications.
The US FDA’s Fast Track process is designed to get important new medicines to patients more quickly, facilitating the development and expediting the review of therapies intended to treat serious conditions and address unmet medical needs. Companies whose programs are granted Fast Track designation are eligible for more frequent interactions with the US FDA during clinical development and potentially accelerated approval and/or priority review, if relevant criteria are met.
KT-621 is an investigational, first-in-class, once daily, oral degrader of STAT6, the specific transcription factor responsible for IL-4/IL-13 signalling and the central driver of type 2 inflammation, and currently in phase 2 clinical testing. In the Phase 1 clinical study in atopic dermatitis patients, KT-621 demonstrated deep STAT6 degradation in blood and skin, robust reductions in disease-relevant type 2 inflammatory biomarkers, meaningful improvements on clinical endpoints and patient-reported outcomes in AD and comorbid asthma and allergic rhinitis, and was well tolerated with a favourable safety profile. KT-621, the first STAT6-directed drug to enter clinical evaluation, has the potential to transform treatment paradigms for more than 140 million patients around the world, including children and adults, suffering from type 2 diseases such as atopic dermatitis (AD), asthma, bullous pemphigoid (BP), chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), chronic spontaneous urticaria (CSU), and prurigo nodularis (PN), among others.
Atopic dermatitis is the most common form of eczema, a chronic inflammatory disease that causes the skin to become inflamed and irritated, making it extremely pruritic (itchy). Atopic dermatitis occurs most frequently in children but also affects adults. It can affect a patient’s quality of life and lead to additional complications, such as infections and sleep loss. While there are currently available medicines for atopic dermatitis, such as topical therapies and injectable biologics, there remains a significant unmet need and opportunity to improve treatment options for millions of patients.
Kymera develops 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.
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