BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) closed Tuesday’s trading session at $8.35, almost two weeks after it announced additional topline data from its Phase 2 ZENITH-1 trial evaluating Oral BCX7353.
The company revealed topline results from the Phase 2 ZENITH-1 trial that included data collected from the 250 mg and 500 mg regimens. BioCryst revealed that the data from the clinical trial demonstrated consistency with previously reported results. The clinical trial evaluated BCX7353’s efficacy performance as a treatment against hereditary angioedema (HAE).
According to the reported data, BCX7353’s 750 mg single oral dose was well tolerated, and its performance was also superior to that of the placebo (p<0.05). Its performance was, therefore, better than the placebo in most of the efficacy endpoints that were evaluated in HAE patients especially in those whose condition is acute.
“The results of ZENITH-1, with onset of action within one hour, duration of effect of a single dose over 24 hours,” stated BioCryst’s Chief Medical Officer, Dr. William Sheridan.
BioCryst eyes regulatory approval through planned Phase 3 clinical trial
Dr. Shiridan also noted that the research team observed a strong response from the efficacy dose in all the dose levels. He also described the results as exciting news especially for patients that are in dire need of an oral treatment option to combat acute HAE attacks. The Chief Medical Officer also revealed that the impressive results had encouraged BioCryst to rapidly advance BCX7353’s 750 mg oral dose into a Phase 3 clinical trial. This particular clinical trial will focus on securing regulatory approval in the European Union and also in the U.S.
BioCryst previously reported oral BCX7353’s tolerability and efficacy data for the 750 mg dose in a press release announced on September 4, 2018. The ZENITH-1 Phase 2 clinical study was a double-blind, randomized, placebo-controlled oral dose trial. The study enrolled 63 patients, out of which 58 of them were treated with at least one dose of oral BCX7353. The study treated 33 patients with the 750 mg dose, 14 patients with the 500 mg dose and 14 patients with the 250 mg dose.