Biosergen successfully completes second cohort of BSG005 phase I trial

June 30, 2022: Biosergen AB (“Biosergen” or the “Company”) today announced that the Safety Review Committee found no safety issues in the second 6-volunteer cohort in the Single Ascending Dose part of BSG005’s phase I trial. The trial will escalate to the next dose level (cohort 3) as planned.

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 trials will demonstrate, that BSG005 is a safe polyene anti-fungal compound, which is the most important step in the clinical development of BSG005. 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 male 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 and tolerability of BSG005. It is conducted in the Nucleus Network phase I Unit in Melbourne, Australia.

We will on an ongoing basis report study progress and we expect to report top line data from the SAD part of the trial in Q4 2022 and from the MAD part in Q1 2023.

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. 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.

For further information, please contact:

Peder M. Andersen MD, CEO
Telephone: +45 2080 2470
E-mail: peder.andersen@biosergen.net

Certified Adviser
Erik Penser Bank
Telefon: +46 8 463 8000
E-mail: certifiedadvisor@penser.se

This information is such information that Biosergen AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication on June 30, 2022

ABOUT BIOSERGEN
Biosergen is a clinical stage biotechnology company that employs all its organisational and financials resources on the clinical development of BSG005. BSG005 is a potentially disruptive antifungal drug with blockbuster potential based on significant safety and potency advantages over competing antifungals, including Amphotericin B, in more than a decade of laboratory and preclinical studies. The research behind BSG005 and its unique properties has been documented in over 20 peer reviewed scientific papers. Biosergen initially aims BSG005 towards invasive fungal infections that claim the lives of hundreds of thousands of immune-compromised AIDS-, cancer- and transplant patients every year. At equal dose levels BSG005 shows a three-to-fourfold potency advantage against relevant fungal strains compared to current standards of care, while being completely free of the kidney toxicity hampering other drugs in its class. The Company is also developing BSG005 Nano where the drug is packed in special nano particles to specifically target the lung, often the first affected organ in an invasive fungal infection. BSG005 Nano Oral is an extension of BSG005 Nano. An oral formulation would greatly increase the usefulness, particularly as a prophylactic and as home treatment after transplants or cancer treatment to prevent invasive fungal infection. Biosergen has received orphan drug status for BSG005 in the United States.