benfovir Announces First Subjects Dosed in Phase 1 Clinical Trial of B-OT/ B-OT IS BEING DEVELOPED FOR THE TREATMENT OF VIRAL INFECTIONS
Darmstadt (ots)
benfovir AG has reached another major milestone by moving its first compound into clinical development with the start of a Phase 1 testing B-OT in healthy volunteers.
benfovir AG, a German pharmaceutical biotechnology company focused on developing small molecules against viral infection such as SARS-CoV-2 virus, today announced that the first healthy volunteers have received benfo-oxythiamine (B-OT) in a Phase 1 clinical trial (BV-01-101) designed to evaluate the safety, tolerability, and pharmacokinetics in healthy human volunteers.
B-OT is a novel compound that prevents the virus replication by inhibiting the sugar metabolism and the formation of a crucial viral building block (ribose-5-phosphate) induced in the infected cell by a virus such as SARS-CoV-2.
B-OT is an inhibitor of transketolase, the key enzyme of the Pentose Phosphate Pathway. The crucial role of transketolase for virus replication has been demonstrated in non-clinical studies among other against SARS-CoV-2 replication.
The metabolic pathways of host cells are actively exploited by a virus for its replication and pathogenesis. Targeting host factors rather than viral enzymes to terminate viral infection is a promising alternative antiviral strategy.
B-OT has completed all GLP toxicology studies. Drug substance and Investigational Medicinal Product (benfo-oxythiamine, capsules) have been manufactured under conditions and practices required by the GMP regulations. The clinical trial BV 01-101 has been approved under the EudraCT Number: 2021-005616-60.
Dr. Isabelle Ahrens-Fath, Chief Scientific and Development Officer at benfovir AG: "We are very excited to be testing B-OT in a Phase 1 clinical trial, to evaluate its safety and pharmacokinetics in healthy volunteers. Targeting an enzyme specifically involved in the sugar metabolism of an infected cell is an innovative approach that should allow to block the SARS-CoV-2 virus replication independently of its gene sequence and mutations."
About the company: benfovir AG is a pharmaceutical biotech company based in Darmstadt in Hesse that specializes in the therapy of viral infections such as the SARS-CoV-2 virus. At this stage, one compound is under clinical development. This compound inhibits the sugar metabolism in infected cells in such a way that the formation of the crucial building block (ribose-5-phosphate) for virus production is disabled and at the same time the overshooting of the immune system is prevented. The near-term goal of benfovir is to quickly move forward with the clinical development of B-OT and receive marketing approval to provide a new therapeutic option for SARS-CoV-2 infection and Covid-19 disease as soon as possible.
Presse contact:
benfovir AG
Gräfenhäuserstr. 26
64293 Darmstadt
E-Mail: info@benfovir.com
www.benfovir.com
Original content of: benfovir AG, transmitted by news aktuell