Biosergen completes the first Multiple Ascending Dose (MAD) cohort of BSG005 phase I trial

January 16, 2023: Biosegen AB (“Biosergen” or the “Company”) today announced that the Safety Review Committee has approved escalation to the next 6-volunteer cohort in the Multiple Ascending Dose (MAD) part of BSG005’s phase I trial.

BSG005 is Biosergen’s lead development compound. It is a novel anti-fungal molecule from the group of polyene macrolides known for their broad anti-fungal and fungicidal effect, including on resistant and difficult-to-treat fungal strains, which make them unique within all antifungal drug classes.  The successful completion of the phase I trial will demonstrate, that BSG005 is a safe polyene anti-fungal compound with no impact on kidney function. The main short-coming of other polyenes are their severe side effects, such as nephrotoxicity.  Breaking through this barrier makes BSG005 a candidate for first line therapy against severe invasive fungal infections.

The clinical phase I trial is a double-blinded, placebo-controlled study in up to 72 healthy volunteers (subjects). The trial is designed as a Single Ascending Dose (SAD) study followed by a Multiple Ascending Dose (MAD) study to investigate the safety, tolerability and pharmacokinetics of BSG005. It is conducted in the Nucleus Network phase I Unit in Melbourne, Australia.

The SAD part of the trial is completed and data are being analysed and will soon be ready for release.

Biosergen’s CEO Peder M. Andersen comments:

“We are on a good track with our trial and are looking forward to go to the next dose level in the MAD part of the trial. If the trial continuous to show that BSG005 is well tolerated and that we can achieve what we believe are thereapeutic concentrations of the drug in the bloodstream of the subjects at safe doses, Biosergen will have taken a very significant step forward. I look forward to keeping you updated as the results come in.”

Phase I study design

The phase I study is divided into two sequential parts:

• The Single Ascending Dose (SAD) part of the trial will enrol up to 42 subjects divided into 7 groups of 6 subjects each. In each cohort, 4 subjects receive a single dose of BSG005, whereas 2 receive placebo. Each subject participates in just one treatment cohort, and no subject receives more than one dose of BSG005 (or placebo as the case may be). The dose of BSG005 will be increased for each progressive group if previous dose levels are well tolerated and no safety issues observed. These safety reviews are performed by the  study’s Safety Review Committee after each dose level.
• The Multiple Ascending Dose (MAD) part of the trial will enroll up to 30 subjects divided into 5 cohorts of 6 subjects each. In this part of the trial, the subjects receive infusion daily over 7 days with increasing dose of BSG005 for each cohort. While the objectives of the Single Ascending Dose trial above is to establish a basic understanding of BSG005’s pharmacokinetics and maximum tolerated dose when given as a single dose, the Multiple  Ascending Dose part of the trial aims to establish what dose level of BSG005 is required to obtain a steady, clinically relevant concentration of the drug in the subject’s blood stream.