- Equillium (EQ, Financial) did not secure FDA's Breakthrough Therapy designation for itolizumab.
- The FDA is open to evaluating longer-term outcomes for itolizumab in aGVHD treatment.
- Equillium plans to accelerate the closure of the EQUATOR study following FDA feedback.
Equillium, Inc. (EQ), a biotech firm based in La Jolla, California, announced that the U.S. Food and Drug Administration (FDA) has not granted Breakthrough Therapy designation for itolizumab. The decision also affected the potential pathway for Accelerated Approval based on data from the EQUATOR study for the first-line treatment of acute graft-versus-host disease (aGVHD).
While the FDA's feedback focused on response outcomes at Day 29, they expressed willingness to consider additional endpoints, specifically longer-term results, if supported by independent data. Equillium's CEO, Bruce Steel, highlighted the company's disappointment but reiterated their commitment to leveraging itolizumab's favorable safety profile and overall data to explore further clinical development options.
The company plans to promptly close the EQUATOR study in response to the FDA's feedback. Equillium, with cash and cash equivalents amounting to $14.5 million as of March 31, 2025, anticipates funding operations into Q3 2025. The firm continues to evaluate strategic options to advance itolizumab and its other therapeutic candidates targeting immuno-inflammatory diseases.
