BioCryst funded for Ebola treatment trials

Aug. 13, 2014 @ 05:55 PM

BioCryst Pharmaceuticals has received an additional $4.1 million in funding from the National Institute of Allergy and Infectious Diseases to advance treatment research for the Ebolavirus.

The funding will be used for the Phase 1 clinical human safety trials of BCX4430, a treatment for hemorrhagic fever viruses, the virus classification including Ebola.

According to the NIAID, BCX4430 has shown efficacy in animal infection models for Ebola and Marburg viruses. The Phase I trial is expected to begin in late 2014 or early 2015.

BioCryst’s shares, as well as those of some other drug makers, rose sharply amid a strong U.S. focus on Ebola.

On August 7, Canada-based Tekmira Pharmaceuticals Corporation announced that the FDA changed the status of its Ebola treatment, TKM-Ebola, from a full clinical hold to a partial clinical hold.

Under this new status, individuals infected with the virus may begin to receive the treatment. Tekmira’s U.S. shares rose by about 26 percent in the day following the announcement.

Over the last month, BioCryst’s shares have gone up by nearly 17 percent.

"The ongoing Ebola epidemic in West Africa emphasizes the urgent need for safe and effective antiviral agents for hemorrhagic fever virus diseases,” Dr. William P. Sheridan, chief medical officer at BioCryst, said in a release. “With these additional funds, BioCryst can move forward with important non human primate efficacy studies, an IND (Investigational New Drug) filing, and Phase 1 human trials of intramuscular BCX4430," he said.

BioCryst declined to comment further.

Russ Britt, Los Angeles bureau chief for financial information for the website MarketWatch, said the outbreak has caused a scramble among companies to address Ebola and find a treatment, and this has caused some unsteadiness in share prices.

 “There’s going to be volatility (in stock prices) because there’s a bit of frenzy surround Ebola,” Britt said.

Britt, who anchors the Health Exchange blog for MarketWatch, wrote in a Tuesday post that Tekmira’s shares fell by nearly 22 percent.

He said that investors have calmed down because they realize it may be a while before these companies realize profits from treatments.

But, he said, BioChryst share prices appear to be steadier than Tekmira’s and some other Ebola research companies’.

NIAID initially granted a contract to BioCryst in September 2013. The contract is valued at up to $22 million over five years.

To date, NIAID has awarded $13.5 million of the funding. The additional $4.1 million comes from the NIAID amending the contract to allow for the safety trials and to conduct efficacy studies in primates to assess the effective doses ranges and schedules.

According to the Centers for Disease Control and Prevention, hemorrhagic fever viruses refer to a group of illnesses that characteristically damage the vascular system, resulting in bleeding.

All of these viruses, with the exception of yellow fever and Argentine hemorrhagic fever, have no vaccines for prevention. These viruses naturally reside in animal hosts, such as rodents, but in the case of Ebola and Marburg, the hosts are unknown.

The Ebola outbreak, which started around March, has spread to four African countries and has 1,176 reported cases, according to the CDC.

The CDC Outbreak Chronology dates to 1976. The current outbreak has the most cases reported since that time and 56.1 percent of those infected have died.

On August 11, the World Health Organization held a panel for the ethical considerations of using unregistered treatments for Ebola.

The panel, comprised of 12 medical professionals from all over the world, concluded that “it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention.”

The WHO also conducted a risk assessment for Ebola in June and determined that cross-border transmission from Africa overseas is low.