"The New England Journal of Medicine" published an article this month containing interesting results from the use of a device produced by Israeli company Insightec in tandem with a drug for treating Alzheimer’s Disease. This is an initial study that is not part of a protocol for submitting the product for regulatory approval, but it indicates a possible future use of the company’s technology in the huge Alzheimer market, which is crying out for solutions.
The current study, conducted with the WVU Rockefeller Neuroscience Institute, demonstrated that Insightec’s device facilitated the opening of the blood-brain barrier by means of focused ultra-sound energy on a certain region of the brain. This enables the Alzheimer’s treatment drug to be delivered and rapidly reduce the amount of cerebral beta-amyloid plaque characteristic of Alzheimer’s Disease. The researchers used ultra-sound only on half the brain, with the other half serving as a control. In the side of the brain that was treated, the level of plaque was lower, and the response was quicker.
The idea of using this technology has been around for years. Several developments in the past couple of years came together to make the current trial possible and make it very interesting. The blood-brain barrier is a colorful way of describing the fact that blood vessels in the brain convey certain substances to the brain tissue but not others. Some drugs designed for treating the brain do not reach it in large quantities. This is a problem in treating a range of diseases, including brain cancer, for example, which, because of this limitation, is difficult to treat with chemotherapy.
After years without significant innovation in Alzheimer’s treatment, two new drugs have reached the market in the past year, one from Biogen and Eisai, and the other from Eli Lilly. Both are based on antibodies meant to remove amyloid plaque from patients’ brains. In trials of both drugs, a small but apparently real improvement was found in the condition of patients if their levels of plaque fell sufficiently.
This means that not only are there now new drugs for treating Alzheimer’s Disease on the market, but there is also confirmation of an approach that until recently was highly controversial, namely that reducing plaque ameliorates the patient’s condition. There is therefore importance in the finding that opening the blood-brain barrier enabled the drug used to reduce plaque levels more quickly.
The drug used in the trial with Insightec’s technology was Aduhelm, a previous drug from Biogen and Eisai, which just this week was removed from sale. Biogen is focusing on its new drug, but the use of Aduhelm demonstrates how Insightec’s device can improve the effectiveness of an existing drug that was considered only slightly helpful.
Even with drugs considered effective in the first place, the technology could improve their performance and accelerate their action, which is important in the case of Alzheimer’s, a disease that advances rapidly.
"Focused ultrasound provides a new opportunity for Insightec collaborations with drug companies to improve drug delivery to the brain," said Insightec CEO and chairperson Maurice Ferré. "Only 1-2% of drugs can cross the blood-brain barrier, making progress difficult and patient safety challenging when using large systemic drug concentrations. The ability to disrupt the blood-brain barrier to effectively deliver treatment demonstrates the power and potential of using focused ultrasound technology when addressing complex neurological conditions."
The publication of this trial comes at a good period for Insightec, whose financial results are revealed through Elbit Imaging (TASE: EMITF), which is traded on the Tel Aviv Stock Exchange, and directly and indirectly holds 2.5% of Insightec. The largest shareholder in the company is Koch Disruptive Technologies, a subsidiary of Koch Industries.
To date, Insightec has raised some $550 million. The company has brought several focused ultrasound products to market, designed to burn tissues deep inside the body and brain selectively, to treat diseases such as cancer and Parkinson’s. In 2022, the company had revenue of $96 million, but, despite good revenue growth over the years, the cost of the product and of development have it made it difficult for the company to become profitable. Its most recent financials carry a going concern qualification.
The new study points to an application for Insightec’s product that is too far from the market to affect its results substantially in the near future, but the enthusiasm over this new direction could enable it to raise further capital.
Published by Globes, Israel business news - en.globes.co.il - on February 5, 2024.
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