BioCryst Pharmaceuticals Starts Clinical Trial of Anti-viral Drug

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BioCryst Pharmaceuticals of Durham has begun a Phase 1 clinical trial of an anti-viral drug for treating two serious viral infections, Marburg virus disease and yellow fever.

The randomized, placebo-controlled trial will evaluate the safety, tolerability and pharmacokinetics of escalating doses of intravenous galidesivir in up to 32 healthy subjects, the company reported. In a previous Phase 1 trial of clinical safety and pharmacokinetics in healthy subjects, intra-muscularly administered galidesivir was safe and well tolerated. 

The galidesivir development program is funded mainly by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and by the Biomedical Advanced Research and Development Authority (BARDA). 

“We appreciate the financial support of the federal government for the development of galidesivir as we continue to advance its evaluation as a treatment option for highly pathogenic viral infections,” said Jon Stonehouse, chief executive officer of BioCryst. “Data from this new trial and potential future studies could support the inclusion of galidesivir in the Strategic National Stockpile.” 

The Strategic National Stockpile is the federal government’s large supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency. It includes antibiotics, vaccines, antidotes, antitoxins and other critical supplies.

A broad-spectrum antiviral

BioCryst has global rights to galidesivir, a broad-spectrum antiviral drug. 

In animal studies, galidesivir also has demonstrated survival benefits against several serious viral infections including Marburg, Ebola, yellow fever and Zika viruses. Galidesivir has also demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses.

Since September 2013, NIAID has supported BioCryst in developing galidesivir as a therapeutic for Ebola and Marburg viruses. In September 2018, NIAID awarded the company an additional $3.5 million to support clinical trials of galidesivir in patients with yellow fever. The NIAID development contract totals $43 million.

Since March 2015, BARDA has supported development as a potential treatment for filoviruses. The total BARDA contract value to advance the program through toxicology studies and manufacturing work to support a new drug application is $39.1 million if all contract options are exercised, the company reported.

Marburg disease is a severe, often fatal, type of hemorrhagic fever found in Africa. It is caused by a filovirus that lives in African monkeys.  

Yellow fever is an acute viral hemorrhagic disease transmitted by mosquitoes infected by the yellow fever virus. The disease occurs in tropical and subtropical areas of Africa and South America.

Company focused on rare diseases

BioCryst discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. 

In addition to galidesivir BioCryst has several ongoing development programs. They include an oral treatment for hereditary angioedema, a rare genetic condition that causes severe swelling, and oral ALK-2 inhibitors for treating fibrodysplasia ossificans progressive, a genetic condition in which the body’s muscles, ligaments and tendons ossify, or turn into bone, constraining movement. 

Rapivab (peramivir injection), a viral neuraminidase inhibitor for treating influenza, is BioCryst's first approved product and has received regulatory approval in the United States, Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for Rapivab are ongoing.

BioCryst, founded in 1986, is headquartered in Durham and has a research and development center in Birmingham, Ala. The company’s shares are traded on the Nasdaq stock exchange under the ticker symbol BCRX.

Barry Teater, NCBiotech Writer
Wed, 01/02/2019 - 17:00