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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 that the positive results from the Phase 1 healthy volunteer clinical trial of KT-621, its first-in-class, oral STAT6 degrader, will be featured in two separate late-breaking oral presentations at the European Academy of Dermatology & Venereology (EADV) Congress being held September 17-20, in Paris, France, and at the European Respiratory Society (ERS) Congress being held September 27-October 1, in Amsterdam, Netherlands. Additionally, the Company will share new preclinical data in an EADV poster that builds upon KT-621's compelling characterization in disease-relevant contexts compared to dupilumab.
"These featured presentations highlight the opportunity for KT-621 to expand patient access to a novel oral systemic advanced therapy in many common immuno-inflammatory diseases, such as atopic dermatitis and asthma, that have limited or suboptimal treatment options," said Jared Gollob, MD, Chief Medical Officer, Kymera Therapeutics. "KT-621's impressive and consistent data highlighting robust target and pathway engagement, show 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. We're continuing to rapidly advance this program and are on track to share the BroADen Phase 1b AD study data, and to initiate our first Phase 2b study in AD, both in the fourth quarter of this year."
In the Phase 1 healthy volunteer single- and multiple-ascending dose (SAD/MAD) study presented at EADV and ERS, KT-621 demonstrated rapid, deep and prolonged STAT6 degradation in blood and skin. In blood, >90% mean STAT6 degradation was achieved at all doses above 1.5 mg. Complete STAT6 degradation was achieved in both blood and skin at all MAD doses ≥50 mg. KT-621 demonstrated an impact on disease-relevant Th2 biomarkers in line with or superior to dupilumab, with median TARC reduction up to 37% and median Eotaxin-3 reduction up to 63%. KT-621 was well-tolerated with a safety profile undifferentiated from placebo.
In a preclinical poster presented at EADV, new data show that KT-621 modulated AD-relevant genes in IL-4-stimulated keratinocytes similar to dupilumab. Keratinocytes are key skin cells involved in the disease pathology of AD through epidermal barrier dysregulation. These findings further support the relevance of the STAT6 pathway in Th2 inflammation driving skin diseases, and the potential of KT-621 to fully block Th2 signaling by effectively targeting and degrading STAT6.
The KT-621 BroADen Phase 1b trial, an open label study in patients with moderate to severe AD, is ongoing, with data expected to be reported in the fourth quarter of 2025. Two parallel Phase 2b studies in AD and asthma patients are planned to begin in the fourth quarter of 2025 and the first quarter of 2026, respectively. The Phase 2b studies are expected to accelerate KT-621 development for subsequent parallel Phase 3 registration studies across multiple Th2 dermatology, gastroenterology and respiratory indications.
Posted In: KYMR
