Equillium’s Itolizumab Misses Primary Endpoint in Phase III Trial but Seeks Breakthrough Therapy Designation

Equillium’s Phase III Equator study (NCT05263999) found that its anti-CD6 monoclonal antibody, itolizumab, failed to surpass placebo in achieving complete response (CR) or overall response rate (ORR) at day 29 for acute graft-versus-host disease (aGVHD). However, CR at day 99 showed promise, prompting the company to proceed with a breakthrough therapy designation (BTD) request to the FDA.

Key Study Details:

• 158 patients with Grade III-IV aGVHD or Grade II aGVHD (with lower gastrointestinal involvement).
• Evaluated in combination with high-dose corticosteroids (SOC treatment).
• Conducted in collaboration with Dana-Farber Cancer Institute at Harvard Medical School.

Market and Investor Reaction:

• Stock plummeted 40.7% on March 26 but partially recovered.
• If approved, itolizumab could generate $180M by 2030 (GlobalData estimate).

GvHD Therapy Landscape:

• No approved first-line treatments exist.
• Competitors like Orca Bio and TC BioPharm are advancing in the field.

Equillium remains optimistic about itolizumab’s potential to meet unmet needs in aGVHD therapy.

31-03-2025