Indy biotech startup moves toward trials for stroke remedy

A small Indianapolis biotech startup has raised $800,000 in new funding, which it says will allow it to begin testing a new drug in patients suffering from brain injuries.

Theratome Bio Inc. plans to begin early-stage clinical trials next year of its lead drug, Thera-101, an injectable biologic designed to reduce brain injuries caused by stroke. The goal is to help patients recover motor skills and cognitive functions.

The fundraising represents a breakthrough for Theratome Bio, a 7-year-old company that has been working to commercialize research done by Dr. Keith March of the Indiana University School of Medicine.

March’s earlier research has produced more than 50 patents worldwide that have generated tens of millions of dollars in licensing revenue for the university.

March is best known for inventing the Closer, a device used to close the puncture wound in an artery following heart catheterization. The device has been used in millions of patients.

Theratome Bio said it plans to begin manufacturing small doses of the experimental drug and start clinical trials on patients in the first half of 2019. The plan is to administer the drugs to 24 patients who are undergoing a transaortic valve replacement, a minimally invasive surgical procedure that repairs the valve. Brain injury is a significant complication of the procedure.

The drug is designed to heal brain injuries with a concentrate derived from tissue that promotes regeneration and repair of brain tissues.

“Then we can look, by imaging after the procedure, at the volumes of incidents in the brain, and compare that to before the procedure,” said Michael Coleman, president and CEO of Theratome Bio.

He said early testing of the drug in animals shows that it can dramatically reduce brain injury and significantly improve outcomes.

The company said the new funding is in the form of convertible note, or a short-term debt that will convert into equity. The investors are Indianapolis-based Elevate Ventures, along with angel investors in Indiana and Texas.

The company, formerly known as NeuroFx, had previously raised about $2 million, chiefly from Ambassador Enterprises of Fort Wayne.

Theratome Bio, with six employees and consultants, is based at the Indiana Center for Biomedical Innovation at Methodist Hospital downtown.  

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