TerSera Therapeutics today announced the presentation of positive data from its study of preventing hypersensitivity infusion reactions.
Deerfield, Ill.-based TerSera’s intravenous (IV) cetirizine injection was pitted against IV diphenhydramine in preventing hypersensitivity infusion reactions in patients with breast cancer and other malignancies, according to a news release.
The randomized, double-blind Phase 2 study evaluated TerSera’s cetirizine hydrochloride injection against IV diphenhydramine in 34 patients receiving paclitaxel or anti-CD20 Ab (rituximab, its biosimilar or obinutuzumab). In TerSera’s treatment group, the number of patients with infusion reactions was 2 of 17, versus 3 of 17 in the other group.
Time for discharge in TerSera’s treatment group was 24 minutes less than the other treatment, while treatment-related adverse events totaled three with IV cetirizine and six with IV diphenhydramine.
Patients in the TerSera group were treated with Quzyttir, the first and only injectable second-generation H1 antihistamine approved by the FDA for treating acute urticaria in adults and children six months of age and older. It is not yet approved for the prevention of infusion reactions.
“We are pleased with the results of this Phase 2 study,” TerSera EVP of R&D & CMO Dr. Nancy Joseph-Ridge said in the release. “This is the first study of IV cetirizine compared to IV diphenhydramine for the prevention of infusion reactions, an investigational use of IV cetirizine.”