Nerve Growth Factor and Diabetic Neuropathic Pain
Neurotrophins have significant potential in treating neuropathic pain. Nerve growth factor (NGF) has been well studied and characterized for its role in neuroprotection. NGF decreases in patients with diabetic neuropathy (Verge et al., Pittenger et al), and initial trials show that it is restored to normal by NB-01.
NGF therapy (rhNGF, Genentech) has shown promising Phase II results in improving pain-related endpoints. However, it was discontinued after Phase III showed no efficacy, potentially due to low dose or concentration of drug (Pittenger and Vinik).
As a natural product that elevates NGF safely and impacts AGE and inflammation, NB-01 provides a unique therapeutic opportunity to address a largely unmet need in the treatment of neuropathic pain.
NB-01 for Diabetic Neuropathic Pain — strong preclinical science
NB-01 is a Phase III-ready drug with a completed U.S. Phase II study for safety and efficacy at 16 sites. In early 2019, NB-01 will be starting a Phase III trial designed to demonstrate pain reduction, safety, and to study disease modification with nerve regeneration.
Phase III clinical study for Diabetic neuropathic pain
With our first patient targeted for Q2 2019, NB-01 will havetwo pivotal trials with double-blind treatment for a duration of 12 weeks with a primary endpoint of improved weekly mean of pain scores using an electronic diary.
NB-02 for Alzheimer’s disease
Alzheimer’s disease (AD) affects about 47 billion people worldwide, and that number is expected to increase to 132 billion by 2050. Additionally, the Alzheimer’s disease market is expected to reach $15 billion USD by 2024 and is a market with substantial unmet need, as symptomatic treatments have limited effectiveness, and no disease-modifying therapy is currently available. Today, four drugs are approved for symptomatic treatment of AD, based on acetylcholinesterase (AChE) inhibition (3 drugs) and NMDA receptor antagonism (1 drug).
NB-02 has shown great promise as a neuroprotective agent in pre-clinical studies providing effects on several levels of the pathogenic pathway, providing a clear rationale for IND submission towards a Phase I study. Specifically, the candidate has demonstrated inhibition of acetyl cholinesterase inhibition, as with the current drugs on the market, but more importantly, has also demonstrated inhibition of amyloid-beta plaque formation and inhibition of Tau phosphorylation – both mechanisms implicated to be potential causes of Alzheimer’s disease.
A poster on NeuroBo’s second candidate, NB-02, was recently presented at the Society for Neuroscience’s recent conference, Neuroscience 2018, during a session titled, “Alzheimer's Disease and Other Dementias: Therapeutic Strategies: Preclinical Cellular Models.”
This study, conducted out of Massachusetts General Hospital and Harvard Medical School, shows that active properties in NB-02 demonstrated strong preventative effects of amyloid plaque. The study also concluded that NB-02 has great promise as a potential therapeutic for Alzheimer’s disease.