Research & Development

 

With a focus on neurological disease, Neurodyn takes a portfolio approach to technology development as a way to mitigate risk, as well as enjoy earlier returns on investment.  Neurodyn preferentially isolates BioActive compounds within historically-proven natural treatments, creates new chemical entities where appropriate, validates those drug candidates and sells those assets for early returns. Alternatives to traditional drug development are also explored, such as Medical Foods, as routes which are faster to market with lower regulatory barriers.

 

 

Memogain®

 

Memogain® is a patent-protected innovative drug candidate for the treatment of Alzheimer’s dementia (AD) and other neurodegenerative brain diseases. It is a pro-drug of the plant-derived drug galantamine which has been marketed around the world for over 10 years for the treatment of mild to moderate Alzheimer’s disease.  Galantamine (Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoramine) has recently become generic, with sales of approximately $500 million per year.

Memogain® has the potential to achieve a much higher concentration in the brain while avoiding the systemic adverse effects of existing drugs including galantamine. Memogain® has a dual mode of action; it enhances the responsiveness of alpha-7 nicotinic receptors to acetylcholine, without over- stimulating or desensitizing them. This receptor system is recognised as an important drug target for improving cognition and behavior in AD.  Additionally, Memogain® acts as a cholinesterase inhibitor, like other drugs of its class.

Memogain Slide

In preclinical studies, Memogain® has been shown to dramatically reduce the amyloid plaques burden typical for AD, and to induce new cell growth in the hippocampus, both effects being evidence of disease modification, the ultimate goal of drug development in AD. Memogain® may also offer benefit to patients of Parkinson’s disease, in particular when associated with cognitive impairment.

As a pro-drug of a market-approved drug, Memogain® fulfill the requirements for fast-track regulatory approval in the US and Europe. Thus, drugs approved under FDA’s 505(b)(2) provisions, and the European equivalent, can rely in part on data from existing reference drugs and may achieve market approval in as little as 30 months, with significantly fewer clinical trials and the resulting lower costs.

Recent phase IA clinical trial results demonstrated no significant side effects, as well as improvements to working memory in both young and elderly populations.

Neurodyn is offering an outstanding opportunity for a joint venture on this drug development project, with low development risk in the Alzheimer’s disease market and secondary Parkinson’s market.

Neuroprotectant ND1208

 

Neurodyn Inc. is conducting a drug development program with a class of saponin-based bioactives that show compelling evidence for protection of early stage Parkinson’s disease (PD).

Research supporting ND1208 has shown compelling efficacy in Neurodyn’s patented slow progression model of PD as well as industry standard PD models. ND1208 bioactives are being screened to identify the components which are primarily responsible for the displayed neuroprotective effects, with the goal of developing an optimally neuroprotective formulation for US FDA regulatory approval as a Medical Food.  This class of compounds have an exceptional and well documented historical safety profile.

The ND1208 bioactives are being designed to:slide1

  • intervene at the earliest stages of diagnosed PD
  • slow the progression of PD when used at the earliest stages of the disease
  • be used as a prophylactic by those that may be at risk of developing PD

For further background research into the bioactives under development for the 1208 Medical Food, and related neurological disease please visit www.neuroprotection.ca

 

Progranulin ND602

 

Neurodyn is conducting a drug development program with the biologic progranulin, a secreted growth factor-like protein with demonstrated neuroprotective activity, for the treatment of Parkinson’s disease.  Neurodyn has demonstrated that decreased neuronal progranulin (PGRN) expression is an early event in the development of its patented animal model of Amyotrophic lateral sclerosis-Parkinsonism dementia complex (ALS-PDC), suggesting that PGRN may have some involvement in the neurodegenerative process.

Neurodyn has developed compelling in vitro and in vivo evidence of the neuroprotective effects of PGRN in a variety of models including MPTP-induced cytotoxicity. Recently the Company has completed a series of pre-clinical assessments of PGRN efficacy in models of Alzheimer’s disease (hu-amyloid transgenic), ALS (ALS-PDC, m-SOD1, Zebrafish), spinal muscular atrophy (Zebrafish) and PD (sub-acute and chronic MPTP challenge).  Protection against disease development was demonstrated in each of these diverse models, suggesting that PGRN is capable of exerting broad neuroprotection.

In particular, in collaboration with the Michael J. Fox Foundation, Neurodyn has demonstrated significant neuroprotection in a chronic progressive animal model of Parkinson’s disease.  Rodents were treated with PGRN after experimental Parkinsonism had been induced.  In the presence of disease, PGRN treatment resulted in:

  • the rescue of dopamine producing cells in the brain;
  • protection from the progressive cell death characteristic of Parkinson’s disease;
  • the preservation of normal levels of motor activity, as well as normal control of motor function.

Neurodyn is currently planning late-stage pre-clinical trials for ND602 prior to out-licensing this asset.  Neurodyn is seeking an R&D collaboration with a suitable pharmaceutical company to assist in taking ND602, a therapeutic version of PGRN, to the clinic for Parkinson’s disease.

 

mjfox

Nerve Pain Treatment NQ1123

 

Neurodyn is a world leader in the research of a class of small-molecule, lipophilic compounds that demonstrate multiple mechanisms of action on nerve receptors.

Neurodyn’s compounds are highly selective for neuronal state-dependency, and also act as antagonists for both sodium and TRP ion channels. This drug discovery platform is based on bioactives identified in plant extracts demonstrating pre-clinical and human clinical efficacy specific for neuropathic pain relief, but lack the numbing or burning effects caused by topical nerve pain products on the market today.

Neurodyn’s lead compound NQ1123 and other new patent-protected chemical entities (NCE’s), are within a class of NCE’s exhibiting a strong neuronal state-dependent selectivity for the inactivated state.  Since high-frequency ectopic discharges of action potentials from sensory neurons are thought to cause   neuropathic pain, blockade of a significant fraction of inactivated sodium channels (such as Nav1.7) in these sensory neurons may be a desirable mechanism (i.e. use-dependent block) to achieve clinical pain  relief in chronic pain states. Inhibition of aberrant nerve firing, while maintaining normal function, possibly provided by state-selective compounds like these, may explain the clinical effects that are seen with the naturally-occurring backbone compounds.  Very few other state-selective compounds have been discovered, making these compounds extremely attractive drug candidates.

NQ1123 Picture

Neurodyn’s development program is initially focused on a topical drug for an orphan-status nerve pain condition, but there is also the potential for oral compounds to be developed.  Animal trials have demonstrated compelling efficacy for the lead compounds.

The company is currently undertaking lead optimization and characterization, prior to developing a product for an IND.

Neurodyn welcomes discussions with biotech and pharma companies who are interested in partnering on this unique first-in-class chemistry.  For additional non-confidential information, please contact: Robert Cervelli at cervelli@neurodyn.ca