BioCryst Pharmaceuticals Inc. started out the flu season earlier this week by commencing Phase III enrollment in the United States for its flu treatment, peramivir, after getting clearance from the FDA to resume the study.
The trial will run throughout the flu season, which generally ends in March, and enroll the remaining 264 patients across the U.S. to complete the 1,300 targeted total. Already, 1,036 patients from other parts of the world have been enrolled in the trial that initially started in February 2000.
Peramivir (RWJ-270201), an orally active small molecule, was being developed by Birmingham, Ala.-based BioCryst and partners Ortho-McNeil Pharmaceuticals Inc. and the R.W. Johnson Pharmaceutical Research Institute, both Johnson & Johnson companies.
This Phase III trial was under way back in May when J&J dropped it, saying the decision was based on a re-evaluation of its internal programs. At the time, BioCryst officials admitted they were disappointed, but indicated they would move ahead with the drug. The trial remains unblinded. (See BioWorld Today, May 1, 2001.)
J&J’s move to terminate the worldwide licensing agreement returned all rights to BioCryst. And although BioCryst hasn’t named a new partner, W. Randall Pittman, BioCryst’s chief financial officer, told BioWorld Today that the company is involved in discussions with other companies.
BioCryst has met with the FDA and received clearance to continue the trial in the U.S., following a delay imposed by the agency due to monitoring requirements. Peramivir is being studied as a treatment for the flu, Pittman said, but “we do believe we may be able to market it down the road as a preventative [agent], but right now, the trial is designed as a treatment.”
He said the trial will measure safety and efficacy of RWJ-270201 for the treatment of influenza A and influenza B infections in adults. The primary endpoint is the length of time from the first dose to the clinically significant relief of influenza symptoms.
“This is a triple-arm trial, including placebo and two drug dosages,” Pittman said. “We should establish the dosage with this trial’s results and then conduct another pivotal Phase III trial that would be two arms, one with placebo and the other with the dose. We wouldn’t need as many subjects in the next Phase III.”
BioCryst’s stock (NASDAQ:BCRX) closed Thursday at $4.95, up 75 cents, or 17.9 percent.
BioCryst has suffered in the past due to decisions surrounding this flu drug. In October 2000, the company’s stock dropped 53 percent to close at $7.187 when then-partner J&J cited “logistical considerations” as the reason for failing to start clinical studies of RWJ-270201 in the elderly. And another time, BioCryst’s stock fell 34 percent when J&J delayed a Phase III trial. (See BioWorld Today, Oct. 13, 2000, and Dec. 27, 2000.)
J&J never blamed delays on the drug’s safety or efficacy.
Peramivir is designed to block the enzyme neuraminidase, which is located on the surface of the influenza A and B virus.