Pamplona Therapeutics today announced that its first-in-class targeted protein degrader for the treatment of autoimmune diseases has received clearance from the U.S. Food and Drug Administration (FDA). The clearance allows the program to advance into human clinical trials.

Pamplona’s first Investigational New Drug (IND) validates both the therapeutic potential of the IRAK4 degrader program and the clinical translatability of its proprietary AI-driven discovery platform, ASTRIDE^®.

The IRAK4 degrader was designed de novo using ASTRIDE^®, which integrates protein-structure–based modeling, advanced artificial intelligence, and mechanism-guided decision-making to enable the discovery of first-in-class and best-in-class targeted protein degradation therapeutics. This successful IND clearance demonstrates the platform’s ability to generate development-ready candidates against clinically validated targets.

IRAK4 is a central signaling kinase in innate immune and inflammatory pathways and has been strongly implicated in multiple autoimmune diseases. By applying a targeted protein degradation strategy rather than conventional inhibition, Pamplona aims to achieve more complete and durable pathway modulation, with the potential to deliver differentiated clinical profiles and long-term disease control.

“This FDA clearance is a major milestone for Pamplona and validates our platform-driven approach,” said Dr. Jinsong Liu, CEO of Pamplona Therapeutics. “It demonstrates our ability to translate AI-enabled molecular design into clinically actionable, first-in-class therapeutics. As we advance our IRAK4 degrader into human studies, we will continue to expand a pipeline built on novel targets and mechanisms, creating multiple opportunities for strategic partnerships.”