A local startup that is looking to reverse the effects of diabetes is on track to move to its first-in-human clinical trial.
TIXiMED completed the final studies required for FDA approval of the trial in December, and Dr. Anath Shalev, the company’s founder and director of UAB’s Comprehensive Diabetes Center and professor in the Department of Medicine, said the company is on track to apply early this year.
“If everything goes well, TIX100 could be in patients by late summer. That is exciting,” Shalev said.
TIX100 targets a protein involved in the beta cell death behind diabetes. In addition to protecting against models of Type 1 and Type 2 diabetes, TIX100 has shown protective effects for nonalcoholic fatty liver disease.
Shalev’s work with TIX100 is two decades in the making. It is a new treatment option that aims to allow people with diabetes is to avoid being completely dependent on daily injections of insulin or insulin pumps.
Her work garnered significant attention from the scientific and diabetes community, and she was encouraged by many to spin off the intellectual property into a startup, prompting her to launch TIXiMED in 2021.
“My response was ‘I’m a researcher, not a businessperson,’” Shalev said. “I was very reluctant. It was really only when we exhausted everything we can do in academia that I began to consider (starting a company). We tried to find other ways of doing it, but this was the best way to reach our goal of getting it to patients.”
TIXiMED officially incorporated with Shalev and Michael Goodrich, principal of Birmingham-based private-business incubator First Avenue Ventures, as co-founders. Shalev also is chief scientific officer for TIXiMED.
We have to have partners in moving this forward,” she said. “I took my sweet time in finding a person I could truly trust, and I found that in Mike Goodrich. We also got to work with great investors for our seed round and now are looking at expanding these partnerships.”
In fall 2022, Shalev received the EntrepreHER award from the Bill L. Harbert Institute for Innovation and Entrepreneurship at UAB as part of its annual Innovation Awards.
Now the work required revolves around questions of manufacturing and navigating regulations: safety and toxicology studies, applying for an investigational new drug designation from the Food and Drug Administration, and so on.
“That is something that needs to be done with professionals,” Shalev said. “It is a massive amount of work, and we are glad to be supported by our scientific advisory board, development team and several expert contractors. I think it’s a good model for a small company — stay lean while employing top expertise.”
Shalev aims to set a precedent for other researchers in the Comprehensive Diabetes Center, hoping to accelerate their discoveries to the clinic.
“Each entity is very different,” Shalev said. “Is it a small molecule? A biologic? At what stage will it need external support? That affects whether you need lab space outside the university, for example. There are many different variables, but what we are trying to do in the Comprehensive Diabetes Center is create a pipeline, so that when the next person may need to start this process, they don’t have to reinvent the wheel.”
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