This article is part of Pulmonology Advisor‘s coverage of the ACAAI 2019 meeting, taking place in Houston, TX. Our staff will report on medical research related to allergies, asthma, and more conducted by experts in the field. Check back regularly for more news from ACAAI 2019.
HOUSTON — BCX7353 reduced attacks of hereditary angioedema (HAE) during a 24-week treatment period, according to study results presented at the 2019 Annual Meeting of the American College of Asthma, Allergy, and Immunology, held November 7 to 11 in Houston, Texas.
BCX7353 is an oral plasma kallikrein inhibitor that has previously demonstrated efficacy for HAE attack prophylaxis in the phase 2 APEX-1 trial (ClinicalTrials.gov Identifier: NCT02870972). An HAE attack is typically characterized by soft tissue swelling, usually in the hands, feet, throat, genitals, and face.
The presented results were from the APEX-2 study (ClinicalTrials.gov Identifier: NCT03485911), which enrolled patients with HAE type I/II. A total of 121 patients entered a 14- to 56-day run-in period to identify a baseline HAE attack rate. The researchers randomly assigned individuals with ≥2 HAE attacks to placebo, BCX7353 110 mg, or BCX7353 150 mg daily for 24 weeks. Patients randomly assigned to BCX7353 continued on therapy at 24 weeks, whereas patients initially assigned to placebo were randomly assigned again to 1 of the 2 BCX7353 dosing groups.
Of the initial 121 patients who were randomly assigned at baseline, 108 individuals completed the 24-week dosing period. Compared with placebo, there were lower rates of investigator-confirmed HAE attacks over 24 weeks with BCX7353 110 mg (P =.024) and BCX7353 150 mg (P <.001). Half of the patients who received BCX7353 150 mg had a ≥70% reduction in the HAE attack rate at 24 weeks compared with 15% in patients who received placebo (P =.002).
There were no reports of drug-related serious adverse events. Drug-related grade 3 or 4 adverse events were reported in 3 patients in the BCX7353 110 mg group. Patients who completed 24 weeks of dosing continued into a 48-week extension study.
Researchers concluded that the finding from their 24-week trial “demonstrates the efficacy, safety, and tolerability of BCX7353 and supports a favorable benefit/risk profile for this novel oral HAE prophylactic therapy.”
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Zuraw B, Lumry W, Banerji A, et al. Oral prophylaxis with BCX7353 reduces HAE attack rates and is well-tolerated: APEX-2 study results. Presented at: 2019 Annual Scientific Meeting of the American College of Asthma, Allergy, & Immunology, November 7-11, 2019; Houston, TX. Abstract P150.