Sage New Client: Notogen's Groundbreaking Regenerative Therapy for Degenerative Disc Disease
Sage Group's new client, Notogen, is a US registered company focused on a regenerative therapeutic, designated NTG-101, for treating chronic back and neck pain caused by degenerating spinal discs (eg Degenerative Disc Disease, DDD).
NTG-101 is available for licensing, strategic partnering or acquisition.
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 an intradiscal molecular therapy injection comprised of two growth factors (rhTGF-β1 & rhCTGF) in an excipient solution. NTG-101:
· SUPPRESSES inflammation and biochemical causes of pain
· HALTS disc degeneration
· PROMOTES repair and disc regeneration
NTG-101 is supported by 20 years of world-class research and numerous publications regarding notochordal cells in the spinal disc. This work is the basis of Notogen’s discovery of NTG-101 which preserves critical cells and mediates degeneration and inflammation while promoting the presence of healthy disc tissues in laboratory in vitro and in vivo models. Importantly, while humans are born with notochordal-rich spinal discs, these notochordal cells disappear as humans age and by the time humans are between 10-13 years of age, they no longer have any notochordal cells in their spinal discs. In substantive preclinical studies, NTG-101 as demonstrated robust anti-inflammatory, anti-catabolic and pro-anabolic effects in animal models of DDD.
DDD is a huge market opportunity with high prevalence, cost burden and unmet need. DDD and chronic back and neck pain and the associated opioid epidemic are among society’s most significant medical issues. A product that can fill this large unmet need will be a blockbuster, with huge growth or exit opportunities
There are no safety concerns with NTG-101 even though it contains growth factors (GFs) because:
➢ NTG-101 is injected into an isolated, immune-privileged disc compartment, so there is limited or no systemic interaction with GFs
➢ TGF-β1 and CTGF naturally occur and behave safely (and very differently) within the avascular, ischemic and hypoxic disc environment, as compared to elsewhere in the body
➢ NTG-101 contains nanogram amounts of GFs; if GFs leaked out of the disc, GFs would be undetectable since lower amount than normally found in blood serum
Clinical trial protocol design:
➢ Phase I/IIa clinical trial with minimal patient numbers has been designed with FDA guidance
➢ cGMP Manufacturing: high-quality CMO in the US has produced cGMP TGF-β1; CTGF production to be completed with or by partner
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