Concenter BioPharma claim they have the answer to treat the $850b annual diabetes epidemic! Interview conducted by Ben Woolf and Deborah Amsallem.
Concenter Biopharma are a subsidiary of Silkim Pharma Ltd., which developed a novel, protected Core-Technology Platform of drugs for proven treatments of various inflammatory disorders of multiple indications. The platform is the result of extensive investigation of animal models of human diseases. Each molecule in the Platform has 3 synergistic and parallel Mechanisms of Action – a potent anti-inflammatory agent, a strong iron chelator, and an antibiotic agent.
What is the professional background of Concenters founders?
The story really begins with Chief Scientific officer Prof. Mordechai (Mottie) Chevion who has a Chemistry and Physics (B.Sc.), Physical Chemistry (M.Sc.), and Pharmaceutical Chemistry (Ph.D.)
Around 20 years ago in his laboratory in Hebrew University – The Hebrew University-Hadassah Medical School, he began searching for different solutions, coming across two families of drugs that now form the IP of the company, reaching a deep understanding of the mechanisms of a specific platform of molecules.
Following successful and showing zero safety issues in numerous pre-clinical trials in 8 species of animals and for 10 different indication, some people then tried the product, providing textual and harvested results, showing advocacy on one hand and safety on the other. Treating multiple indications, he decided to move from the lab to the commercial stage.
I was brought in 5 years ago in order to achieve this, the inventors, led by Prof. Chevion signed an agreement with the University technology transfer company – “Yissum” and Hadassah medical center technology transfer company – “Hadasit”. Then, the company signed an agreement with the inventors giving it full rights to continue developing the IP and to commercialize it.
Moving forward we built the team and filed with the FDA and are moving towards clinical trials 1 and 2a. For more information on clinical trials click here.
What made you want to lead this project?
Firstly, the CSO is my father, and since I trust him and the science it was a relatively easy decision.
Secondly, I am one of the people which tried the drug for psoriasis. And I have been using it for 6 years now, so experienced first-hand the efficacy and safety of the drug (topical cream for psoriasis), which was a cost effective, safer (non-steroidal) and better drug than what is available today. People need a better choice than what is available on the market.
How much of a problem is Type 2 diabetes?
With type 2 diabetes, your body either resists the effects of insulin — a hormone that regulates the movement of sugar into your cells — or doesn’t produce enough insulin to maintain normal glucose levels. Diabetes affects many major organs, including your heart, blood vessels, nerves, eyes and kidneys. Although long-term complications of diabetes develop gradually, they can eventually be disabling or even life-threatening. Some of the potential complications of diabetes include Heart and blood vessel disease (heart disease, stroke, high blood pressure and narrowing of blood vessels (atherosclerosis); Nerve damage (neuropathy); Damage to the nerves that control digestion can cause problems with nausea, vomiting, diarrhea or constipation; Kidney damage – failure or irreversible end-stage kidney disease; Eye damage – cataracts and glaucoma; Slow healing – cuts and blisters can become serious infections, which may heal poorly; Hearing impairment; Skin conditions – bacterial and fungal infections; Sleep apnea; Type 2 diabetes seems to increase the risk of Alzheimer’s disease…
It is a global epidemic costing $850 Billion/Year. In many countries – 1 out of 3 people is either Diabetic or Pre-Diabetic! Over 450 Million people worldwide currently have diabetes and hundreds of millions MORE (…probably over a Billion) are diagnosed with pre-diabetes; 12% of Global health expenditure is spent on diabetes.
What clinical applications are being developed in Concenter BioPharma?
In regards to Type 2 diabetes many other drugs don’t necessarily treat the disease, but only the symptoms or its complications. Concenters claim is they actually treat the disease by restoring insulin resistance to normal levels!
One demonstration in diet-induced diabetes in Sand Rats by markedly inhibiting the appearance and the degree of hyperglycemia, arresting the conversion of insulin-resistance state to fully-blown diabetes; attenuating cataract formation and diabetes-induced retinopathy. Proved efficient on healing of diabetic foot ulcers (DFU) on human patients. They have also shown that they can actually restore resistance to normal levels and treat the disease. With following clinical trials to show what has been done with animal models will work in humans as well.
What do the pre-clinical trials already accomplished with rats and mice actually look like?
Model 1 involves taking animals that are accustomed to eating very low energy diets and giving them high energy, high fat and sugar so they develop diabetes, once they become diabetic they are treated, and after 3 weeks their blood glucose levels return to normal, while animals untreated stay diabetic.
Model 2 is genetically induced, here the animals are much sicker when initiating the treatment but still showed the same trend of lowering blood glucose to normal levels, not to complete normal levels, because animals are extremely sick when beginning the trials. So, it might turn out that for someone who is diabetic for 40 years the chance for 100% recovery is not as good compared with 2 – 10 years after they attain the disease.
What’s your upper hand?
100’s of companies are working on different drugs, diagnostics, digital or other treatments, but when looking at the pipeline we are one of the few that say we can actually treat the disease itself! This is due to a specific Mechanism of action of our molecules that no other drug has, which is unique.
What are the main challenges you currently face?
Every start-up has a hurdle of securing the right funds. Then it would be to begin clinical trials and conduct them as quickly as possible, finalising phase 1 within a year, then re-file FDA application with updated information and move towards phase 2 and 3 before reaching patients. We forecast to bring our drug to market in 3-4 years.
However, we think we’re right on track, with a strong and dedicated scientific advisory board, with 3 of the world’s leaders in type 2 diabetes, bio’s here.
What are the internal operations, team and culture like?
We are a small team, internally we have a regulatory consultant and our Scientific advisory board and many operations are outsourced, patents are dealt with by a leading IP patent office in Israel.
In terms of culture specifically we put science first, our data and what we do is according to the guidelines published by the regulatory body and make sure all that we do is correct. We are very focused on reaching our goals, being cost efficient.
We really believe we will bring a major change to 100’s of millions of people suffering from type 2 diabetes with our novel drug.
What would your treatment look like, and how will it change the daily life of a patient?
Current protocols of treating type 2 is you start with 1 drug, then another, then another, and then you might add insulin injections, and as the years go by, usually you have to raise the doses and add additional drugs to your daily routine and treatment.
We believe in many cases what we could have a “mono-treatment”, you will only need our drug in order to treat your disease and the drug will be administered orally, a pill a day to treat your situation. And as mentioned – this pill will actually treat the disease and not the symptoms or complications which in our case would be greatly reduced or totally abolished.
Do you have any advice to other CEO’s and Entrepreneurs ??
Every situation I have been involved with throughout my life has its own challenges; the only generic is once you believe in what you are doing, the data, the science, the product you have, then you have to never give up until you make it.
And even if you have the best, it does not guarantee success, it will make day to day progress easier, but you have to work very hard, and never give up on what you truly believe in.
What is it like developing a business like yours in Israel?
The people in Israel are experienced, in pure R&D, regulatory, commercialization, and in local or international drug developments. No shortage, also the hospitals have great clinical trial units, there are relevant service providers, ample companies and relevant trade associations for clinical trials.
We have the whole ecosystem required for R&D, commercialization, regulatory, IP and so on and the government promotes our sector very effectively.
In Jerusalem specifically there is everything mentioned above, also special entities that are specific to the city that we hope to further capitalize and build upon.