Therapeutic Potential of NTG-101, a Single Dose Injectable Treatment for Degenerative Disc Disease, Demonstrated in Preclinical Large Animal Study Published in Nature Publishing Group's “Scientific Reports”
Notogen Inc., a biotechnology company developing regenerative therapeutics for conditions related to spinal degeneration, orthopedics and sports medicine, announced preclinical data for NTG-101, the Company’s single-dose, injectable protein-based therapeutic candidate for degenerative disc disease (DDD), was published online today in Scientific Reports, A Nature Publishing Group journal.
The paper, "NTG-101: A Novel Molecular Therapy that Halts the Progression of Degenerative Disc Disease," discusses preclinical results supporting NTG-101’s therapeutic potential for patients with spinal disc degeneration. The study, which was conducted in large animals that develop DDD in a manner akin to that of humans, provides compelling evidence that a single injection of NTG-101:
1. Suppresses known biochemical causes of painful degenerative discs to very low or undetectable levels, while simultaneously suppressing pro-catabolic processes and stimulating regeneration of the disc extracellular matrix.
2. Preserves disc height that otherwise significantly decreases.
3. Results in the preservation of biomechanical properties similar to normal, whereas control, saline injections induce deterioration of biomechanical properties.
4. Leads to long lasting therapeutic effects that include the suppression of pro-inflammatory and pro-catabolic genes and significantly upregulated pro-anabolic genes in the canine in vivo subjects as well as human disc cells obtained from spinal surgery patients.
“This manuscript details the first ever, comprehensive, large animal pre-clinical study of a novel, molecular therapy to treat degenerative disc disease,” said Mark Erwin, DC, PhD, Co-Founder, CSO and senior author of the paper. "The findings are supportive of NTG-101 as a means to impede disc degeneration, promote disc regeneration, halt inflammation, and suppress the expression of molecules secreted by discs that are known causes of pain.”
The study, which is available online at www.nature.com/articles/s41598-018-35011-4, was conducted in collaboration with researchers from University Health Network, University of Toronto and University of Alberta.
Upon completion of cGMP manufacturing and IND submission, Notogen expects to initiate Phase I clinical trials for NTG-101 in 2020.
NTG-101 is protein-based biologic designed to mediate the progression of spinal disc degeneration disease (DDD) and induce a restorative effect. NTG-101 is administered as a single intradiscal injection, containing a combination of recombinant human (rh) Transforming growth factor beta 1 (TGF-β1) and Connective tissue growth factor (CTGF) proteins plus excipient factors. In preclinical studies, NTG-101 demonstrates robust anti-inflammatory, anti-catabolic and pro-anabolic effects in animal models of DDD.
Notogen is biotechnology company developing regenerative therapeutics for conditions related to spinal degeneration, orthopedics and sports medicine. Notogen’s lead candidate, NTG-101, is a targeted, non-surgical, non-cellular protein-based biologic for the treatment of degenerative disc disease. For more information, please visit www.notogen.com
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