Notogen is an early-stage biotechnology company developing a biologic solution to a defining medical issue of our time – chronic back and neck pain caused by degenerating spinal discs (degenerative disc disease; DDD). Notogen’s lead product, NTG-101, is a novel, disease-modifying regenerative biologic therapy for DDD that has been specifically designed from more than 20 years of study into the cause of DDD. Notogen has published impressive large animal in vivo data demonstrating that NTG-101 suppresses inflammation and biochemical causes of pain in spinal discs, stops disc degeneration and induces a regenerative effect within the disc.
Notogen is currently scaling up the cGMP manufacturing of the APIs in NTG-101. Once non-GMP material is available in late 2020, Notogen will commence its IND-enabling toxicology study. The end of this study in H1-2021 will line up with the production of cGMP material for NTG-101, at which point Notogen will submit its IND to the FDA and begin its Phase I/IIa human clinical study. Notogen currently has funding on hand to progress its development program through to IND filing and is currently seeking the additional funding necessary to conduct the human clinical trials necessary to demonstrate safety, tolerability and efficacy in human patients.