Biosergen

This abstract will feature the clinical data obtained from the recently completed Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics of BSG005, Biosergen’s proprietary anti-fungal candidate from the polyene macrolide class. The Phase 1 trial, conducted at the Nucleus Network Phase I Unit in Melbourne, Australia, was a double-blinded, placebo-controlled study involving several cohorts of healthy volunteers. The trial design incorporated both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, which successfully assessed the safety and tolerability of BSG005.

Details of the oral presentation are as follows:

Title: First in human data on BSG005, a genetically engineered polyene macrolide evaluated in a double-blinded placebo-controlled Phase 1 trial

Paper Status: Accepted oral
Theme: New anti-fungal agents
Session Details: Symposium 7 – The respiratory mycobiome, October 21, 2023
Presentation Time: 15:25 – 15:35
Presenting Author: Tine Kold Olesen

The oral presentation at TIMM-11 will showcase the final study findings and provide in-depth insights into the safety profile of BSG005. The presentation will delve into key aspects of the promising potential of BSG005 as a novel anti-fungal therapy. Following the live presentation, the abstract will be made available on the Biosergen website for further reference.

Participation at TIMM-11 and the acceptance of this abstract for oral presentation underscore Biosergen’s commitment to scientific excellence and its ambition to contribute substantially to advancing the field of medical mycology.

“This presentation marks a very significant moment for Biosergen. It is the first time Biosergen, and especially our lead asset BSG005, is presented to a broad audience of mycology experts and physicians treating invasive fungal infections. The fact that we can now confirm in humans that BSG005 has no harmful impact on the kidneys – as demonstrated in our toxicology studies – holds immense importance for our further development journey of BSG005,” commented Peder M. Andersen MD, CEO of Biosergen. He further elaborated:

The audience will also gain insight into BSG005’s unique attributes. Being a polyene drug it is – as shown in pre-clinical data – a fungicidal drug with a very broad coverage against various fungal strains. Particularly noteworthy, we have preliminary data showing effect against Candida auris, a strain that is resistant to the current last-resort anti-fungal drug, Amphotericin B. A great event for Biosergen and of high interest to the anti-fungal world.”