FDA approves LyGenesis drug application

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The U.S Food and Drug Administration (FDA) recently approved Pittsburgh-based biotechnology company LyGenesis’ Investigational New Drug (IND) application.

The company developing cell therapies that enable organ regeneration.

LyGenesis will be conducting a phase 2a study on the safety, tolerability, and efficacy of its novel cell therapy for patients with end stage liver disease (ESLD).

“The FDA clearance for our IND and the start of our phase 2a study in patients with ESLD is a testimony to our robust preclinical research program, the unmet need in advanced liver disease, and our novel approach to organ regeneration,” Dr. Michael Hufford, LyGenesis co-founder and CEO, said. “Moreover, the lack of genetic manipulation, ease of administration, and low cost of goods for our cell therapy forms the foundation for a promising and scalable first commercial product.”

LyGenesis recently also completed more than $11 million in private financing of convertible notes. This was led by Juvenescence, a life sciences company developing therapies to modify aging, and the Longevity Vision Fund, a venture capital fund investing in technologies with the potential to disrupt life sciences.

LyGenesis will use the funds for the clinical trial, which is expected to begin early this year. It also will use a portion of the funding for other cell therapies.