EP262 Drug Shows No Benefit Over Placebo for Chronic Hives Patients
A recent study concluded that the drug EP262 did not outperform a placebo in treating chronic hives symptoms.
NEW DELHI, Nov 9: In a recent clinical trial, the drug EP262 did not demonstrate significant benefits over a placebo for patients with chronic hives, known as chronic spontaneous urticaria (CSU). The Phase II CALM-CSU study involved 113 adults who continued their regular antihistamine treatment while taking either EP262 or a placebo for six weeks.
The primary measure of effectiveness, the Urticaria Activity Score over seven days (UAS7), showed reductions of 10.4 points with placebo, 8.4 points with 50 mg of EP262, and 12.0 points with 150 mg. However, neither EP262 dosage showed a statistically significant improvement compared to the placebo.
Both dosing groups exhibited some improvement in itch and hive severity, but those differences were not substantial enough to be clinically relevant. The trial reported that there were no serious adverse events associated with the drug, and all doses were generally well tolerated by participants.
The study’s findings raise questions about the potential efficacy of EP262 in treating CSU. Dr. Metz, a leader in the study, indicated that these results do not support the use of EP262 as an effective treatment in conjunction with antihistamines, as the improvements were not statistically significant.
The research team noted that their results could be influenced by the study’s small sample size and the specific patient population. They also mentioned that a planned evaluation of a lower EP262 dose was halted due to the lack of effectiveness.
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