madman
Super Moderator
* While the timeline remains long, and the team said that it could take 10-15 more years before the prodrug could ever see the market, the progress and results shown in initial testing are promising.
news.ku.edu
Rather than trying to get around the liver, SteroCore founders took a different approach: They created a prodrug that works with the liver’s natural physiology.
A prodrug is an inactive compound that becomes active after it metabolizes. The drug delivers something that is inactive, and the body activates it so that patients receive the therapeutic effect. This strategy leverages liver physiology rather than avoiding it.
Hageman said that the human body naturally removes testosterone quickly, a signal of how strong the hormone is. The goal of testosterone is that it is secreted, does its job and is cleared by the body as quickly as it can.
Designing a compound that accounts for that biological reality is the innovation behind STC-101.
Commercial drug development requires slow-moving discipline.
“When you start with a preclinical study that you eventually want to get to be a commercial product, you’ve got to do it in steps,” Salamoun said. The first step in these trials is molecular docking simulations.
Computational modeling for STC-101 demonstrates whether the compound can bind to the proteins and enzymes in liver. If it does, researchers can validate that it is possible. From there they move to bench studies using liver cells.
The team saw that the prodrug was being converted to testosterone on the bench; following this confirmation, researchers began rodent studies, which also demonstrated activation. Team members expressed their excitement that their compound is promising and is being de-risked one model at a time.
Hagemen emphasized the importance of modeling throughout the process of drug development. Researchers start with in vitro experiments (studies conducted outside of living organisms in controlled environments), then in vivo animal experiments (studies conducted within, on, or using a whole living organism). The in vivo experiments allow scientists to predict what is going to happen in a clinical setting; it’s how to convince potential investors that the drug being developed is worthwhile to invest in.
The team has conducted testing up through in vivo rodent testing; its next steps is to scale up and perform studies with larger in vivo models. While the timeline remains long, and the team said that it could take 10-15 more years before the prodrug could ever see the market, the progress and results shown in initial testing are promising.
Startup from School of Pharmacy seeks to redefine oral testosterone replacement therapy
SteroCore, a startup emerging from the University of Kansas School of Pharmacy, is developing a novel oral testosterone therapy designed to work with, rather than bypass, the liver’s natural physiology.
A different approach: Using the liver instead of avoiding it
Rather than trying to get around the liver, SteroCore founders took a different approach: They created a prodrug that works with the liver’s natural physiology.
A prodrug is an inactive compound that becomes active after it metabolizes. The drug delivers something that is inactive, and the body activates it so that patients receive the therapeutic effect. This strategy leverages liver physiology rather than avoiding it.
Hageman said that the human body naturally removes testosterone quickly, a signal of how strong the hormone is. The goal of testosterone is that it is secreted, does its job and is cleared by the body as quickly as it can.
Designing a compound that accounts for that biological reality is the innovation behind STC-101.
De-risking the science
Commercial drug development requires slow-moving discipline.
“When you start with a preclinical study that you eventually want to get to be a commercial product, you’ve got to do it in steps,” Salamoun said. The first step in these trials is molecular docking simulations.
Computational modeling for STC-101 demonstrates whether the compound can bind to the proteins and enzymes in liver. If it does, researchers can validate that it is possible. From there they move to bench studies using liver cells.
The team saw that the prodrug was being converted to testosterone on the bench; following this confirmation, researchers began rodent studies, which also demonstrated activation. Team members expressed their excitement that their compound is promising and is being de-risked one model at a time.
Hagemen emphasized the importance of modeling throughout the process of drug development. Researchers start with in vitro experiments (studies conducted outside of living organisms in controlled environments), then in vivo animal experiments (studies conducted within, on, or using a whole living organism). The in vivo experiments allow scientists to predict what is going to happen in a clinical setting; it’s how to convince potential investors that the drug being developed is worthwhile to invest in.
Next steps
The team has conducted testing up through in vivo rodent testing; its next steps is to scale up and perform studies with larger in vivo models. While the timeline remains long, and the team said that it could take 10-15 more years before the prodrug could ever see the market, the progress and results shown in initial testing are promising.
