Penny Stock Equillium Falls After Itolizumab Treatment Fails To Show Improvement In Response Rates In Graft Versus Host Disease Patients

Equillium, Inc. EQ released topline data on Thursday from the Phase 3 EQUATOR study. The study evaluated itolizumab in the first-line treatment of patients with acute graft-versus-host disease (aGVHD).

The study results did not demonstrate a meaningful difference in complete response (CR) or overall response rate (ORR) at Day 29 between patients treated with itolizumab and placebo.

However, the company said that statistically significant and clinically meaningful benefits in longer-term outcomes were achieved, including complete response at Day 99, duration of complete response, and failure-free survival.

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Itolizumab exhibited a favorable safety and tolerability profile and did not increase the risk of clinical sequelae, including infection or sepsis, the primary drivers of the high mortality associated with aGVHD.

“Based on these data and prior FDA guidance, we have filed for Breakthrough Therapy designation and have been granted a meeting to discuss the potential for Accelerated Approval of itolizumab for first-line treatment of aGVHD, a rare disease where one-year mortality exceeds 40 percent and itolizumab has already received Orphan Drug and Fast Track designations,” said Bruce Steel, CEO at Equillium. “We expect feedback from the FDA during May and, if positive, we would plan to submit a biologics license application during the first half of 2026.”

The company reported that statistical significance was achieved in several other secondary endpoints demonstrating improvement in longer-term outcomes:

• The duration of CR favoring itolizumab, with a median of 336 days vs. 72 days, p-value 0.017.
• Failure-free survival favoring itolizumab, with a median of 154 vs. 70 days, a p-value of 0.043.
• Complete response at Day 99 favoring itolizumab, with 35 (44.9%) vs. 22 (28.6%) patients, p-value 0.035.
• The positive trend in overall survival favored itolizumab, with a mortality of 19 (24.4%) vs. 25 (32.5%) patients.
• Steroid tapering (steroid lowering) and rates of primary disease relapse and chronic GVHD were similar for both treatment arms.

In February, Equillium revealed topline results from the Phase 2 study evaluating itolizumab for moderate to severe ulcerative colitis.

Itolizumab demonstrated clinical efficacy after 12 weeks of treatment, achieving a clinical remission rate of 23.3% compared to 20.0% for adalimumab and 10.0% for placebo.

Itolizumab achieved key secondary endpoint of endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo.

Price Action: EQ stock is down 33.3% at $0.51 at the last check on Thursday.

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