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Novel Drug Therapy with Potential to Cure Neuro-Degenerative Diseases

Periodic Reporting for period 1 - NeuroProtect (Novel Drug Therapy with Potential to Cure Neuro-Degenerative Diseases)

Reporting period: 2018-06-01 to 2018-09-30

Neurodegenerative diseases are growing into a global challenge, as medical advances ensure more individuals live longer. By 2020, there will be more than 40 million people worldwide with AD and by 2040, without the development of disease modifying drugs, this will rise to more than 80 million. Currently no cure exists for these diseases: all current therapies for neurodegenerative diseases are symptomatic and do not revert or stop neuron death.
NeuroProtect is promising drug candidate to cure some prevalent neurodegenerative diseases, such as Optic Atrophy (OA), Amyotrophic Lateral Sclerosis (ASL), Parkinson’s Disease (PS), Huntington’s Disease (HD), and Alzheimer's Disease (AD).
During the Feasibility Study:
• We have strengthened our belief that we have a unique, strong market position. We are highly competitive both with regards to the novelty of our product (the unique functions) and compared with our nearest competitor’s market strategies.
• A thorough business plan is ready to move the project further. The key partners were selected to join our drug development program. The out-license business model for our company is confirmed.
• Our IP can be well protected, and we have good position result of FTO.
We are now applying for SME Instrument Phase 2 in order to complete and submit the IND/CTA package. Specifically, the IND/CTA phase includes developing the GMP manufacturing process for NeuroProtect (SBC003), appropriate toxicology and safety studies and regulatory activities.
During the feasibility study project, we screened the preclinical study partners, assessed the market of these diseases, concreted the business model, assessed and defined global IP strategy, and made drug development business plan.
For each aspect of preclinical studies, we compared the proposals from at least 3 suppliers and selected the best one as our partner.
In this project we conducted thorough studies on the disease problem, epidemiology, market size and the market competitions for these diseases by using Globaldata database. We got to know that there is no cure in the market (including the pipelines) for these diseases. Considering the unique functions (strong neuroprotective, neurorescuing and axon-regenerative effects) of our product, it will be in the predominant position in the market.
We studied business model for typical biotech company. The best way is to exit at the point that clinical trial phase 2 is finished. Through a deal with a pharma, the pharma will take over and finish the costly clinical trial phase 3 and then make the product go to market.
At the same time, the outcome of the IP assessment is positive, we strengthened our business model and business plan. The out-licensing business model is a doable option for our company and will build a win-win solution between my company and the buyer (normally big pharma). The next step IND package grogram is planned. We selected the partners who have very solid industry experience on preclinical studies to join our drug development program.
Now we are ready to move ahead to execute the IND/CTA package.
Current therapies are symptomatic at best: the root cause of neurodegenerative diseases is neuron death in the central nervous system. Despite the increasing need for solutions, there are no drugs that can modify the progression of the disease.
SBC003 is currently in a preclinical drug candidate stage of development. Pharmacokinetics studies showed that SBC003 is orally bioavailable and strong efficacy for OA and ALS. To move forward to clinical stage, we are going to complete and submit the IND/CTA package. Specifically, the IND/CTA phase includes developing the GMP manufacturing process for NeuroRegenerator (SBC003), appropriate toxicology and safety studies and regulatory activities.
Unlike most other compounds indicated for neurodegenerative diseases, SBC003 has multiple modes of action with potential to modify the neurodegenerative disease pathology.
The difference in the yearly cost of an elderly person with AD vs. a healthy elderly person is around €5,000. The yearly healthcare cost for PD patients is around €5,000 and for ALS over €100,000 due to the severe medical interventions such as ventilators and tracheostomy. Instead of having a lifelong symptomatic treatment, patients will take NeuroProtect for around one year, which considerably reduces the economic burden of these diseases. But, what really counts is the benefit in terms of quality of life and extension of longevity.
Prevalent Cases by countries(Year 2017) for OA, ALS, PD, HD, and AD
Disease Market Size by Countries (Year 2017) for OA, ALS, PD, HD, and AD