“This is a new way to treat diabetes,” said CEO Dr. Nikolai Kunicher.
Betalin Therapeutics has developed the first bio-artificial pancreas, composed of pig’s lung tissue and insulin secreting cells. The artificial pancreas would be implanted into the patient and connect with his or her blood vessels, and then be able to measure the body’s sugar level and secrete an optimal amount of insulin needed to balance blood sugar.
So far, according to Kunicher, the team has completed animal trials. Human clinical trials are slated to launch within the next 12 months. Animal trials don’t always translate to humans because of species differences, among other reasons.
Betalin has raised $3.5 million and is looking to raise another $5 million before the trial begins. It is expected that the biological pancreas will cost around $50,000 per patient.
According to the World Health Organization, there are around half-a-billion people worldwide that suffer from Type I or Type II diabetes. Of those, according to Kunicher, some 160 million people are insulin dependent.
There are numerous treatments available for those who suffer from diabetes, and treatments vary depending on individuals’ needs. Insulin-dependent diabetics generally take insulin by injection or by using a pump. There are also oral diabetes medications.
Among those who suffer from diabetes is Betalin advisory board member and 1989 Nobel Prize winner in Chemistry Sidney Altman. He is considered one of the world’s foremost molecular biologists.
Altman told The Jerusalem Post that he and his mother both suffer from Type II diabetes, and that His brother died of the disease. He said that when he was approached about the company, he quickly became intrigued.
“This is a new approach,” Altman said, noting he believes it will have global impact.
Prof. Aryeh Warshel, also a Nobel Prize winner (2013 in Chemistry), sits on the scientific advisory board as well.
The company was founded about four years ago based on a decade of research conducted by Prof. Eduardo Miterani of the Faculty of Science at the Hebrew University. He examined how cells need to come into contact with supportive tissue that simulates the extracellular environment in the human body.
“The pancreas is unique in that it functions as a complete autonomous organ, not as single cells, and can therefore be located anywhere in the body,” Miterani explained.
Today, Dr. Avi Treves, founder and former CEO of Hadasit Ltd. and Gamida-Cell Ltd., heads the company’s research and development. He said that the technology represents the next phase of what is known in the scientific community as the Edmonton Protocol, through which doctors are already implanting pancreatic islets into patients.
“Doctors take a suspension of islets from a donor and implant them into a patient,” Treves explained. “This can cure patients for a few years. But it is a complicated procedure and has many disadvantages, such as that the tissue dies overtime, and patients have to be immunosuppressed because you are implanting a foreign tissue.”
In contrast, he said, Betalin’s artificial pancreas microstructure enables cells to function better and for a longer time. It should be easier and more economical.
Already, the company is collaborating with clinics in Germany, England, Miami, China and Italy that were doing islet transplantation to test the technology. It was recently awarded a bi-national collaboration grant by the Innovation Authority and the Italian government, together with Prof. Lorenzo Piemonti, who is described as a world-renowned diabetes researcher.
Betalin also won the “Best Innovative Pharma Start-up” award from the Mixiii Biomed 2017 Conference, the largest event of Israel’s life science industry.
Treves said he believes the company is looking at only a one-phase trial of about two years and then it will be able to fast track to regulatory approval by proving efficacy.
He envisions the Betalin pancreas being rolled out gradually to a limited number of diabetic patients, though he believes it will ultimately serve all insulin-dependent individuals. He said that the next phase would be using the technology to treat other indications that result from hormonal dysfunction.
“Companies in the US are working on this with many more people and huge budgets,” Treves told the Post. “We are a small company with a small budget, but we have excellent people who know how to do the work.
“The basic tech is ingenious,” he continued. “It will work.”