RESEARCH TRIANGLE PARK, NC, USA I October 26, 2016 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that results from a study of galidesivir (formerly BCX4430) administered to Rhesus monkeys infected with Zika virus (ZIKV) will be presented as a late-breaker oral presentation at IDWeek 2016 taking place in New Orleans October 26-30, 2016.
The presentation titled “BCX4430, a Broad-Spectrum Adenosine Analog Direct-Acting Antiviral Drug, Abrogates Viremia in Rhesus Macaques Challenged with Zika Virus,” will be presented by James B. Whitney, PhD, Assistant Professor of Medicine, Harvard Medical School, and Principal Investigator in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. Dr. Whitney is also an Associate Member of The Ragon Institute of MGH, MIT and Harvard. The presentation will take place during the “Late Breaker Oral Abstracts” session on Saturday, October 29 at 11:10 AM Central Time.
A pre-clinical study in rhesus monkeys was completed to assess the safety and efficacy of galidesivir against ZIKV infection. Fifteen animals were subcutaneously challenged with Puerto Rican ZIKV isolate. Animals were distributed into three groups (n=5/group). Ninety minutes after challenge, group one received intramuscular (I.M.) doses of 100 mg/kg galidesivir BID on Day zero, followed by 25mg/kg BID for nine additional days. Group two received only 100 mg/kg galidesivir I.M. BID on day zero. Group three received vehicle only. Multiple endpoints, including ZIKV RNA levels in plasma, urine, saliva, and cerebrospinal fluid, were followed. Immune activation, complete blood counts, chemistries and galidesivir pharmacokinetics were longitudinally monitored throughout the study.
All control animals developed high-level viremia by day two post infection. In group one, the monkeys did not develop detectable plasma viremia. In group two, the monkeys were partially protected: two of five animals from this group had detectable plasma ZIKV RNA, but the onset was delayed and magnitude of viremia reduced compared to controls.
Galidesivir dosing in rhesus monkeys was well-tolerated and offered significant protection against ZIKV challenge. These results warrant further study.
About Galidesivir (BCX4430)
Galidesivir is a broad spectrum antiviral in advanced development under the Animal Rule for the treatment of Ebola virus disease. A Phase 1 clinical safety and pharmacokinetics study in healthy subjects has been completed, and in animal studies, galidesivir has demonstrated survival benefits against a variety of serious pathogens, including Ebola, Marburg, 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. BioCryst is developing galidesivir in collaboration with U.S. Government Agencies and other institutions.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst currently has several ongoing development programs: BCX7353 and other second generation oral inhibitors of plasma kallikrein for hereditary angioedema, and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is a potential treatment for filoviruses. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza is BioCryst’s first approved product and is currently marketed in the U.S., Japan, Taiwan and Korea. Post-marketing commitment development activities are ongoing as well as activities to support regulatory approvals in other territories. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 126
RESEARCH TRIANGLE PARK, NC, USA I October 26, 2016 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that results from a study of galidesivir (formerly BCX4430) administered to Rhesus monkeys infected with Zika virus (ZIKV) will be presented as a late-breaker oral presentation at IDWeek 2016 taking place in New Orleans October 26-30, 2016.
The presentation titled “BCX4430, a Broad-Spectrum Adenosine Analog Direct-Acting Antiviral Drug, Abrogates Viremia in Rhesus Macaques Challenged with Zika Virus,” will be presented by James B. Whitney, PhD, Assistant Professor of Medicine, Harvard Medical School, and Principal Investigator in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. Dr. Whitney is also an Associate Member of The Ragon Institute of MGH, MIT and Harvard. The presentation will take place during the “Late Breaker Oral Abstracts” session on Saturday, October 29 at 11:10 AM Central Time.
A pre-clinical study in rhesus monkeys was completed to assess the safety and efficacy of galidesivir against ZIKV infection. Fifteen animals were subcutaneously challenged with Puerto Rican ZIKV isolate. Animals were distributed into three groups (n=5/group). Ninety minutes after challenge, group one received intramuscular (I.M.) doses of 100 mg/kg galidesivir BID on Day zero, followed by 25mg/kg BID for nine additional days. Group two received only 100 mg/kg galidesivir I.M. BID on day zero. Group three received vehicle only. Multiple endpoints, including ZIKV RNA levels in plasma, urine, saliva, and cerebrospinal fluid, were followed. Immune activation, complete blood counts, chemistries and galidesivir pharmacokinetics were longitudinally monitored throughout the study.
All control animals developed high-level viremia by day two post infection. In group one, the monkeys did not develop detectable plasma viremia. In group two, the monkeys were partially protected: two of five animals from this group had detectable plasma ZIKV RNA, but the onset was delayed and magnitude of viremia reduced compared to controls.
Galidesivir dosing in rhesus monkeys was well-tolerated and offered significant protection against ZIKV challenge. These results warrant further study.
About Galidesivir (BCX4430)
Galidesivir is a broad spectrum antiviral in advanced development under the Animal Rule for the treatment of Ebola virus disease. A Phase 1 clinical safety and pharmacokinetics study in healthy subjects has been completed, and in animal studies, galidesivir has demonstrated survival benefits against a variety of serious pathogens, including Ebola, Marburg, 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. BioCryst is developing galidesivir in collaboration with U.S. Government Agencies and other institutions.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in rare diseases. BioCryst currently has several ongoing development programs: BCX7353 and other second generation oral inhibitors of plasma kallikrein for hereditary angioedema, and galidesivir, a broad spectrum viral RNA polymerase inhibitor that is a potential treatment for filoviruses. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza is BioCryst’s first approved product and is currently marketed in the U.S., Japan, Taiwan and Korea. Post-marketing commitment development activities are ongoing as well as activities to support regulatory approvals in other territories. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 126
