Issue link: https://tmcpulse.uberflip.com/i/1182394
t m c » p u l s e | n o v e m b e r 2 0 1 9 9 as well. So you shouldn't buy it. Eat some food. And once you've turned on the muscle building machinery and put the protein there to provide all the building blocks, it's on." Human trials Watowich plans to start testing RT-001 in humans in late 2020. "By next year, quarter four, we will have filed with the FDA a document showing all the safety studies, all the efficacy studies, how we'd manufacturer it, and so on," Watowich said. "We'll begin human trials quarter four of next year." The first six months of human trials will analyze how the drug behaves in the body, starting with a small dose. If there are no problems, Watowich and his team will increase the dose to the level they think will be the treatment. "The first study is done with about 40 patients—very small," Watowich said. "We will add a cohort of a group of about 12 elderly people, individuals aged 55 to 70, because as you age you can run into renal problems." Then, toward the end of 2021, they'll begin an efficacy study of about 300 patients aged 55 to 75—"healthy, normal people," Watowich said, "not gym rats or marathon runners." With this larger group, the scientists are looking for answers to specific questions. "What we're asking is, if you go to the gym and you take this pill, will you get much stronger?" Watowich said. "Instead of increasing your strength by 15 percent, can we get you up to 25 percent, 30 percent, 50 percent stronger? We know in mice they almost double their strength. We don't expect to double the strength of elderly people, but can we get them significantly above what would happen if they would just go to the gym?" If all goes well, the team will then study hip fracture patients recover- ing from surgery to see if the drug can accelerate recovery. "In a six- to nine-month trial, can we make post-hip fracture patients stronger such that they survive, thrive and return to independent liv- ing? Only a small fraction of elderly with hip fractures ever return to independent living," Watowich said. If the team hits all these mile- stones, the drug could be available by the end of 2023. Collaborators on RT-001, which will get a snappier name before it goes to market, include colleagues from UTMB; Chris Fry, Ph.D., formerly of UTMB and now asso- ciate professor at the University of Kentucky's College of Health Sciences; Nicholas Young, Ph.D., an assistant professor of biochemistry and molecular biology at Baylor College of Medicine who will be doing some epigenetic profiling; and researchers at The University of Texas MD Anderson Cancer Center, who will be analyzing tissue samples. In addition, Watowich has spun out a biotechnology company, Ridgeline Therapeutics, housed at JLABS @ TMC, to develop drugs to reverse Type 2 diabetes, obesity, muscular dystrophies and sarcopenia. One day, Watowich's drug could benefit everyone over a certain age. "If everything works, you start taking the drug at 40 and you keep up an exercise program—you stay active," he said. "If you do that, you're not going to have as many diseases that affect you in terms of cardiovascular health."