Lawrence-based Clara Biotech seeking clinical trial for possible COVID-19 therapy

photo by: Chad Lawhorn/Journal-World File Photo

The Bioscience and Technology Business Center at the University of Kansas is pictured in June 2017.

A Lawrence biotechnology company is in the process of solidifying clinical trials for a therapy that could drastically reduce the more complicated symptoms of COVID-19.

Clara Biotech, based on the University of Kansas’ west campus, says it has developed a way to directly target infected lung tissue using pieces of information already in the body — called exosomes.

Exosomes are a relatively new find, Clara Biotech CEO Jim West told the Journal-World. Discovered around 10 years ago, the particles — which are 1/1,000th the size of cells — are what allow cells to communicate with one another. Through that communication, the therapy is then able to directly target infected cells and tissue.

To his knowledge, West said, Clara Biotech is the only facility that has the ability to isolate exosomes so they can be used for therapeutic purposes. Since the study of exosomes is so young and still developing, other technologies can only isolate the particles in a way that contaminates any potential therapeutic use.

“We’re able to extract pure exosomes from any solution, and that solves a major need in the market,” he said.

There is a specific classification of exosomes, West said, that have regenerative and anti-inflammatory properties. The goal of the COVID-19 therapy is to isolate that class of exosomes and target infected lung tissue to limit the pulmonary complications a patient may face.

“Our hope is that the therapy we’re developing would be able to reduce the lung inflammation and reduce complicating factors around COVID-19, keep more people out of the hospital, keep more people off ventilators and help to restore and regenerate that lung tissue,” West said.

West and Dr. Mei He, Clara Biotech’s founder and an assistant professor at the University of Kansas, worked in conjunction to develop the therapy with Dr. Ilya Rachman, a physician-scientist and former clinical faculty member at UCLA.

“Our ability to use this technology to pivot and address critical global health challenges as they arise is exciting,” said He in a news release announcing the therapy. “The time is now to move this research forward and make this therapy available to the masses.”

While a clinical trial for the therapy is not yet scheduled, West said the company was working with a number of funding sources and agencies to get things moving quickly.

“We have a pathway identified, and we’re basically putting the pieces together for that right now,” he said.

All told, the costs for the trial and its preparations will be around $14 million, and the process will likely take seven to nine months, West said. The group is breaking the costs down into smaller milestones as the process toward the therapy’s approval begins.

“We understand that full number is a big number, and there are some funding sources that might be able to help with that, but we’re trying to break it into smaller chunks,” he said.

For a company that launched as a startup in 2018, the rapid advancement of exosome technology and finding a possible therapeutic treatment in the midst of a global pandemic has been exciting, West said.

“I want people to know that we exist and have an exciting new opportunity that can have a substantial quality of life improvement not only for current virus outbreak but for the after effects,” he said.

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