 |
SALT LAKE CITY, Jan. 27, 2023 /PRNewswire/ -- DiscGenics, Inc., a clinical stage biopharmaceutical company focused on developing cell-based regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Injectable Disc Cell Therapy (IDCT or rebonuputemcel), an injectable, allogeneic discogenic progenitor cell therapy for the treatment of symptomatic lumbar degenerative disc disease (DDD).
"This designation represents a critical validation of our novel approach to utilizing a manufactured live progenitor cell population derived from donated adult human intervertebral disc tissue to treat disc degeneration," said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. "As committed stewards of this technology, we look forward to partnering with the FDA to expedite our drug development program and to ultimately realizing the potential of IDCT to address the unmet medical needs of millions of patients with this painful and debilitating condition."
The RMAT designation is based on positive two-year clinical data from DiscGenics's first-in-human study of IDCT. As previously reported, the study demonstrated IDCT's potential to safely increase disc volume and provide rapid, durable improvements in low back pain, function, quality of life, and pain medication usage out to two years post-injection in patients with lumbar DDD.
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline products, including cell therapies. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for that disease or condition. RMAT designation provides sponsors with intensive FDA guidance on efficient drug development, including the ability to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the biologics license application (BLA), and other opportunities to expedite development and review.
IDCT is the first and only product intended for spine care to receive this designation.
FDA also granted IDCT Fast Track designation in 2019, making RMAT the second special regulatory designation DiscGenics has received from the FDA.
About DiscGenics
DiscGenics is a privately held, clinical-stage biopharmaceutical company developing cell-based regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics's first product candidate, IDCT (rebonuputemcel), is an allogeneic, injectable discogenic progenitor cell therapy for symptomatic, mild to moderate lumbar disc degeneration. IDCT is a mixture of live Discogenic Cells, which are a manufactured progenitor cell population derived from donated adult human intervertebral disc tissue, and a viscous carrier. As the only company in the world to develop an allogeneic cell therapy derived from intervertebral disc cells to treat diseases of the disc, DiscGenics has a unique opportunity to offer a non-surgical, potentially regenerative solution for the treatment of patients suffering from the debilitating effects of back pain. For more information, visit discgenics.com.
Logo - https://mma.prnasia.com/media2/561675/DiscGenics_Logo.jpg?p=medium600
