- Sanofi will advance an experimental inflammatory disease drug into Phase 2 clinical testing after its biotechnology company partner Kymera Therapeutics reported Wednesday what it described as encouraging results from a small study.
- The trial was designed to test whether Kymera’s drug would be processed in the bodies of people with one of two inflammatory skin conditions in the same way as it had in healthy volunteers. Not only did the drug meet that goal, but study data suggested clinical improvements such as clearing skin and lessened itching.
- Kymera described these early results as important for the science behind its drug, a pill designed to degrade harmful proteins. “We believe that, for the first time, we have demonstrated clinical impact of a degrader, KT-474, outside of oncology and in complex inflammatory diseases,” said Kymera CEO Nello Mainolfi in a statement.
The startups have raised significant funding from venture and public investors, as well as drawn the attention of large pharmaceutical companies like Pfizer, Roche, Vertex Pharmaceuticals and Sanofi.
Their basic idea is to use small molecule drugs to degrade or destroy disease-causing proteins, rather than finding ways to bind to them and thereby block their activity. Arvinas, C4 and Nurix have each made their way into clinical testing with protein-degrading drugs, but their programs are focused on cancers.
While Kymera is working in oncology, too, it is further along with its inflammatory disease drug, dubbed KT-474. Two years ago, Sanofi paid Kymera $150 million to access KT-474 and an earlier-stage program, which are aimed at a protein known as IRAK4 that’s thought to play a role in diseases like hidradenitis suppurativa, atopic dermatitis and rheumatoid arthritis.
The data released Wednesday are the most tangible sign of the drug’s potential, suggesting it could work as intended in hidradenitis suppurativa or atopic dermatitis and potentially curb some of patients’ symptoms. A Phase 2 study, which Sanofi intends to start in 2023, would be a much higher hurdle of whether KT-474 can actually benefit patients in a significant way, however.
Still, Kymera is encouraged and views the data it generated as “clinical validation” for targeting IRAK4 with a protein degrader. Data showed that its drug knocked down IRAK4 levels in both the blood and skin.
Treatment was also generally well tolerated. No serious side effects or drug-related infections were reported, and no patients discontinued the drug or lowered its dose due to adverse events. Kymera did note “modest, non-adverse” changes in heart rhythm, known as QTcF prolongation, between days 7 and 14 in the study, which later resolved spontaneously.
“The HS and AD patient data are encouraging as they highlight the broad potential of KT-474 and continue to validate Sanofi’s commitment to the target and to [targeted protein degradation]’s unique ability to unlock this critical pathway,” said Naimish Patel, Sanofi’s head of global development for immunology and inflammation, in a statement.
Shares in Kymera rose by as much as 32% Wednesday, before falling back to trade up 20%.
Also on Wednesday, Kymera said testing of two of its protein degraders in cancer continue to advance and that it would share additional data next year.