
A potential treatment for COPD is ready for testing after the U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug Application filed by Kymera Therapeutics, Inc.
The company said in a news release that KT-621 is a potent, selective oral degrader of STAT6 — a signal transducer and activator protein that plays a role in immune response and could address multiple allergic and atopic diseases, including COPD, asthma and atopic dermatitis.
“Unlike traditional oral small molecule inhibitors, we believe that our oral STAT6 degrader has the potential to combine the complete pathway blockade of upstream biologics with the convenience of oral administration and in doing so has the opportunity to transform the current treatment paradigm for atopic and allergic diseases,” said Nellow Mainolfi, PhD, founder, president and CEO of Kymera. “We are excited to advance KT-621 into phase 1 clinical testing and look forward to sharing updates on this program in the future.”
The trial is expected to begin immediately with data to be reported in the first half of 2025. The trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of KT-621 compared to placebo.
STAT6 is a historically undrugged essential transcription factor in the IL-4/IL-13 signaling pathways and the central driver of T helper type 2 (TH2) inflammation in allergic diseases. According to Kymera, multiple gain-of-function mutations of STAT6 have been identified to cause severe allergic diseases and monoclonal antibodies like dupilumab have been approved for many such diseases. Therefore, the company said that STAT6 targeting is supported by both human genetics and clinical pathway validation.
KT-621 is an investigational, first-in-class, once daily oral STAT6 degrader with dupilumab-like activity in preclinical models and the potential to address many allergic and atopic diseases, the company said.