Genmab A/S (CSE: GEN and FSE: GE9D) announced results from the initial stage of the Phase II clinical trial involving 155 patients with active RA. At the primary endpoint of the study in week 7 there was no significant difference between the ACR scores from patients receiving placebo compared to patients treated with HuMax-CD4 in combination with methotrexate. In the placebo group, 24% of patients achieved an ACR20 compared to between 11% and 29% in the four active dose groups.
Treatment with HuMax-CD4 was found to be safe and well tolerated. The number and severity of adverse events was similar across treatment groups including placebo. Following these results, Genmab has decided to wind down its anti-CD4 development program for RA. No further patients will be recruited into the Phase III clinical trial in patients with active RA who have failed to respond to treatment with TNF-alpha inhibitor therapies. Genmab will collect data on patients already enrolled in the Phase III study and investigate the difference between using HuMax-CD4 in combination therapy with methotrexate versus the antibody alone. The company will also collect safety data on these patients. In addition, no more patients will be accrued in the ongoing Phase II RA study.
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