The Company has received the first safety review group outcome of the safety and laboratory data following this first administration of BSG005 in the phase I study in
BSG005 is Biosergens lead development compound. It is an anti-fungal molecule from the group of polyene macrolides known for its broad anti-fungal and fungicidal (killing fungals) effect on a broad range of fungal strains - including resistant and difficult to treat fungal strains. Furthermore in vivo animal data with immunocompromised mouse has shown BSG005 to have a higher potency than comparative products such as Amphotericine B/Ambisome. And the toxicology data has been free of any kidney toxicity which so far has been a strong draw back on the use of AmB which has mainly been as the last resort.
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 over 7 days with once daily infusions to investigate the safety and tolerability as well as the pharmacokinetics of BSG005, Biosergens proprietary antifungal candidate of the polyene macrolide class.
Study objectives
The phase I study is conducted in the Nucleus Network phase I Unit in
- To test the safety of BSG005 in general and specifically as relates to the kidneys. In previous animal toxicology studies BSG005 showed no adverse effects on the kidneys. Kidney toxicity is a key problem for Amphotericin B, the other polyene product on the market.
- The study will also investigate the tolerability of the intravenous infusions of BSG005 and how the body reacts to BSG005.
- Finally, the study will look at the pharmacokinetics of BSG005, meaning that it will investigate what concentrations of drug is achieved in the blood stream after different dose levels, and for how long.
"This is very positive news and promising for the coming administrations of BSG005. First administration in Man is always the most exiting moment in any drug development program. That we with these first administrations have had no adverse event reports at all and nothing in the laboratory data is a promising result and is the best possible start of this phase I study. The study dose escalations are done very carefully and only after full review of each cohort data by the Safety Review Committee. The committee recommends the escalation to the next dose level and if the data we have seen now after the first dosings continue to come out like this, then BSG005 has come a long way on the travel to phase II and phase III and ultimately a Marketing Approval.
We know this is early and few data however very positive.It is well known, that there is a high need for new drugs with a broad anti-fungal action and a high efficacy also against the fungus strains that are resistant to an increasing number of the drugs on the market. Recent reports on high resistance development in
For further information about
Dr.
Telephone: +45 2080 2470
E-mail: peder.andersen@biosergen.net
Certified Adviser
Telefon: +46 8 463 8000
E-mail: certifiedadvisor@penser.se
ABOUT
https://news.cision.com/biosergen-ab/r/the-first-subjects-dosed-successfully-with-no-adverse-events-in-the-phase-i-trial-of-bsg005,c3547809
https://mb.cision.com/Main/20568/3547809/1565349.pdf
(c) 2022 Cision. All rights reserved., source