BioCryst Pharmaceuticals, Inc. has dosed the first patient in APeX-S, a long-term safety trial evaluating two dosage strengths of BCX7353 administered orally once-daily as a preventive treatment in patients with HAE.
“Initiation of the APeX-S trial is an important milestone to support filing and approval of BCX7353, and furthers our core strategy of bringing a once-daily, oral prophylactic treatment to HAE patients,” said Jon Stonehouse, CEO. “Long-term safety results from this trial will supplement efficacy and safety data from the APeX-2 Phase 3 trial, which is also expected to commence in the first quarter of 2018. The ability to run these trials concurrently is beneficial, as it may allow us to more rapidly get this important medicine into the hands of patients who are seeking a better quality of life by eliminating their current injection-based treatment programs.”
APeX-S is an open label two-arm trial to evaluate the safety of two dose levels of BCX7353 (110 mg once daily and 150 mg once daily) over 48 weeks in patients with Type I and II HAE. The trial will enroll approximately 160 patients. Initially, APeX-S will enroll patients who have participated in a previous clinical trial of BCX7353, and in time will be expanded to include patients who have not previously received the drug. Endpoints of the trial include long-term safety, durability of response and quality of life measures.
“The launch of this trial has brought within arm’s reach the fulfillment of the long-standing need of HAE patients for a convenient, easy-to-administer, oral remedy, developed on purpose for the prophylaxis of angioedema attacks,” said Henriette Farkas, MD, PhD, DSc and Principal Investigator of the APeX-S trial.