Kymera Therapeutics is trading higher by as much as 30% today on the back of news that it achieved positive results from its phase 1 healthy volunteer study using its oral STAT6 protein degrader KT-621. This randomized, double-blind, first-in-human, early-stage trial was designed to see if the company could establish an excellent safety profile for this drug in the targeting of patients with immunological disorders. A total of 118 patients were treated, and the data released did actually prove that its mechanism of action (MOA) in using an oral drug like this could establish biologic-like clinical activity in a pill format.
This phase 1 healthy volunteer study was split up to be that of a single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the use of oral STAT6 protein degrader KT-621 in these patients. The final outcome for such an early-stage study was highly ideal, with the final target outcome being the ability to establish complete STAT6 protein degradation across the board in both the blood and skin. Both of these efficacy measures were established in the MAD study setting only, though, with dosing of KT-621 being ≥50 mg.
Another positive finding with the data that was released is in terms of Th2 reduction. This is an important measure because STAT6 transcription factors lead to the IL-4/IL-13 pathway. In turn, this leads to allergic Th2 inflammation that occurs. The whole point is that thymus and activation-regulated chemokine (TARC) reduction observed in patients has been correlated with improved clinical response. The median TARC reduction observed with these healthy volunteer patients was up to 37% at Day 14. This is comparable or possibly superior to that observed in the healthy volunteer study of DUPIXENT [dupilumab].
The bottom line here is that in this healthy volunteer study, it appears as though Kymera is in the stages of showing dupilumab-like biologic activity in a pill with KT-621 in targeting such patients with immunological disorders. With that being said, further proof of this is not that far away. Beyond the release of this healthy volunteer data set, the company is on track to release data from its phase 1b BroADen study using this oral STAT6 protein degrader for the treatment of patients with moderate-to-severe atopic dermatitis [AD] in Q4 of 2025.
Oral degraders being advanced by this company can potentially disrupt the immunology treatment market space, with the potential to be superior to that of DUPIXENT. Consider that two-thirds of this market consists of patients receiving biologics for their disease. An oral pill from this company, like KT-621, would not only offer a more convenient route of administration but could potentially establish a more tolerable safety/efficacy profile. However, this remains to be seen until the release of the phase 1b BroADen study data, expected towards the end of this year.
Even big pharma sees the value potential with protein degraders like KT-621 and others in this company’s pipeline. With that being said, this biotech is developing the use of KT-474 (SAR444656) in collaboration with Sanofi for the treatment of patients with AD and hidradenitis suppurativa (HS). This provides Kymera with another shot on goal targeting patients with AD, besides KT-621. Lastly, it intends to evaluate a new protein degrader from its pipeline, which is KT-579. This has an undruggable transcription factor of IRF5.
The potential with this therapy is to regulate innate and adaptive immune response pathways of a multitude of pro-inflammatory cytokines like IL-6, IL-12, IL-23, and TNF-alpha. Plus, the ability to go after autoantibody B-cells and Type I Interferon (IFN). At the moment, it is currently in the process of running IND-enabling studies for this candidate, but it believes it is on track to possibly begin an early-stage study for this specific program in early 2026. Other catalysts to keep an eye on would go back to the company’s continued development of KT-621 for the treatment of patients with immunological disorders. That is, it intends to initiate two parallel phase 2b studies using this oral STAT6 protein degrader to target patients with AD and asthma in Q4 of 2025 and Q1 of 2026, respectively.