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FDA approves ‘fast track’ for Utah-based DiscGenics

By Jasen Lee, KSL | Posted - Sep 22nd, 2019 @ 8:57pm



SALT LAKE CITY — After years of scientific research, a Utah company’s medical innovation is finally on a quicker path to potential widespread use in human patients.

Recently, Salt Lake City-based DiscGenics — a biotechnology company developing advanced therapeutics to treat patients with diseases of the spinal disc — received “fast track” status from the U.S. Food and Drug Administration for the company’s injectable disc cell therapy. The investigational process is currently being assessed in clinical trials in the United States and Japan to address pain and disability linked to degenerative disc disease — a major producer of chronic lower back pain.

According to the FDA, fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient sooner.

Injectable disc cell therapy is allogeneic, meaning it is available “off-the-shelf” and manufactured using donated adult human disc tissue. Comparatively, an autologous therapy would indicate the cells came from the same patient intended to receive treatment.

“Our therapy is focused at chronic back pain associated with degenerative disc disease,” said Bob Wynalek, chief operating and commercialization officer at DiscGenics. “It’s an extremely large disease state. It’s 25% of the world’s population and is responsible for basically a fourth of all the opioid prescriptions.”

The fast track designation is a special regulatory status that companies can apply for once they have sufficient preclinical and clinical evidence that a product may be able to treat an unmet medical need for a serious medical condition, he added. Under this designation, companies can benefit from early and frequent communication with FDA as well as be eligible for accelerated approval and priority review programs, along with a “rolling review” application process for marketing licensing, he said.

Wynalek said the company is now focusing its efforts on conducting the requisite clinical trials that could eventually get the process approved for commercial use.

“We are thrilled to receive fast track designation for (injectable disc cell therapy) as it recognizes the extremely compelling preclinical and safety data we have generated for ... and underscores FDA’s acknowledgment of low back pain as a serious medical condition with a profound lack of treatment options,” said Flagg Flanagan, DiscGenics chairman and CEO. The designation “reinforces our commitment to working with regulators to identify ways to accelerate development and expedite approval of the therapy within existing regulatory frameworks.”

The injectable disc cell therapy is regulated by FDA’s Center for Biologics Evaluation and Research, a news release stated. Therefore, the company has to adhere to the strict standards of a regulated drug pathway requiring DiscGenics to verify the product has a therapeutic effect, but also meets requisite safety and production standards.

Flanagan acknowledged that the fast track designation is a major milestone for the therapy’s development process, but there are still regulatory and clinical hurdles that have to be overcome before a commercial product could be federally approved for public use in patients. He said if progress continues at a reasonable pace, then a product could be available in two to three years.

“It’s really exciting for us as a validation of our technology and moving forward,” Flanagan said. “The hope is really to help millions of people around the world.”

He said the company is directing its efforts on being prepared to meet that goal by continuing to rigorously test its processes and get the first two clinical trials completed in a satisfactory manner.

Wynalek said developing a therapy that could help a generation of people maintain an active lifestyle is deeply gratifying.

“The prospect of this is that it could increase mobility and (activity) of people who are suffering from (chronic back pain) who are prematurely debilitated by this,” he said.

Formerly located at the University of Utah’s Research Park, DiscGenics announced in February a planned expansion to a 25,000-square-foot space to be developed near the northwest quadrant of Salt Lake City. The new facility will house research and development operations as well as manufacturing, along with 22 employees.

Jasen Lee

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