benfovir AG has reached another milestone by completing the first part of the Phase 1 trial testing transketolase inhibitor
benfo-oxythiamine (B-OT)
Darmstadt (ots)
benfovir AG, a German pharmaceutical company focused on developing small molecules against viral infections such as SARS-CoV-2, dengue and herpes virus, today announced that the first part of the Phase 1 clinical trial (BV-01-101/ EudraCT Number: 2021-005616-60.) designed to evaluate the safety, tolerability, and pharmacokinetics of B-OT in healthy human volunteers has been successfully completed. B-OT represents a prodrug releasing the transketolase inhibitor oxythiamine.
The single ascending dose (SAD) part of the study showed a very good safety and tolerability of B-OT at 5 dose levels. No side effects were triggered by B-OT which was administered once daily. Following single administrations of B-OT, the exposure of the released active compound oxythiamine in terms of C-max and AUC(0-t) increased at higher doses in a slightly over proportional manner.
The multiple ascending dose (MAD) part of the study has now started. B-OT will be now administrated once daily during 7 days at ascending dose at 4 dose levels.
B-OT is a host cell-targeted agent inhibiting transketolase, the key enzyme of the pentose phosphate pathway controlling the production of ribose and acetyl-CoA, two crucial building blocks for new viruses. Targeting an enzyme specifically controlling the production of essential building blocks for new viruses in infected cells is an innovative approach that enables inhibition of SARS-CoV-2, dengue and herpes virus replication independently of its gene sequence and mutations.
Dr. Isabelle Ahrens-Fath, Chief Scientific and Development Officer at benfovir AG: "We are excited about the initial safety, tolerability, and pharmacokinetics results from the SAD part of our Phase 1 study and are confident about the results of the recently started MAD part. benfovir AG is the first and only company to evaluate a transketolase inhibitor at the clinical stage".
About the company: benfovir AG is a pharmaceutical 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 by disabling the formation of the crucial building blocks for virus production (ribose-5-phosphate and acetyl-CoA), and at the same time by preventing the overshooting of the immune system. 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 viral diseases as soon as possible.
Pressekontakt:
benfovir AG
Gräfenhäuserstr. 26
64293 Darmstadt
E-Mail: info@benfovir.com
www.benfovir.com
Original content of: benfovir AG, transmitted by news aktuell