Game Changer: Unique and Novel Nano Transport and Delivery Vehicles for Improved & Better Controlled Drug Activity

Many drugs, currently sold on the market, as well as drugs which are in development stages, are usually not optimally efficient and therefore require advanced transport vehicles, to maximize their absorption capacities and biological activities.

Traditionally, active ingredients in medications are divided into four categories: (1) drugs that are highly soluble and highly absorbent, mostly small water-soluble substances; (2) drugs of low water- solubility, but high levels of absorbency; (3) drugs that are highly soluble, but are challenged in the absorbency properties because they are macromolecules (very large substances); (4) drugs that are neither water- soluble nor absorbent. The last two categories present the pharmaceutical industry a significant challenge. This is where LDS is making the big change and contribution. The company produces a variety of solutions for those “problematic pharmaceuticals”, by developing unique, innovative, and breakthrough nanometric systems for improved drug transport and improved efficacy.

“With the proper transport vehicles, one can increase the drug’s efficacy and activity by directing it to target areas in the body, as well as by increasing its concentration in the formula,” explains Prof. Nissim Garti, the company’s founder and chairman.

LDS started out on the basis of the research of Prof. Garti at the Casali Institute of Applied Chemistry, Department of Chemistry of the Hebrew University of Jerusalem. Today, the company possess its own well-equipped laboratories and offices, and is staffed with 10 researchers, all of whom are graduates of academic scientific degrees. It is engaged in several partnerships, including with some of the world’s leading pharmaceutical companies, and has its own pipeline product developments.

As a biotechnology company, LDS focuses its activities on research, development, and commercialization of innovative, breakthrough, and patented nanometric systems for unique and innovative transport mechanism for drugs and active ingredients. The company has two departments: the first specializes in the controlled release of medications that are insoluble or suffer from non-sufficient permeation and low physical or chemical stability . The second department specializes in health and nutritional supplements, as well as in derma-cosmetic products.

The company was established as a startup in 2013 by Prof. Garti, as a drug delivery formulation company, together with Yissum, the Hebrew University’s commercialization company, and private investors from Australia. Garti, who serves as the chairman and chief scientist, is a professor Emeritus of the Hebrew University of Jerusalem where he did extensive research work, for approximately 45 years. His global reputation in the field is the result of the vast knowledge and experience he acquired as an entrepreneur and an industry personality, which has led him to serve as a consultant for many companies – in Israel and abroad. Over the years he consulted to a variety of pharma, cosmetics, food industries and provided solutions for various products development. Prof. Garti is one of the 27 scientists that were entitled with the recognition of the ‘leading inventors’, which features the Hebrew University researchers. Over the years, Prof. Garti has published over 410 peer-reviewed scientific articles in leading scientific journals, 14 scientific books, and over 80 scientific reviews in leading journals. He has many approved worldwide patents and has even served (twice!) on the committee entrusted with locating the Nobel Prize candidates in the field of chemistry.

The importance of adapting the unique technology to each drug

Dr. Sharon Garti-Levi, the company’s CEO, explains that the importance and efficacy of each and every drug-product, is not only in the active ingredient itself, but also (and sometimes mostly) in the final formulation through which it is administered, as its goal is to enable its solubility, stability, and the transportation to the target organs. “This is what our company does,” she says, emphasizing that “the technologies developed at LDS help identify new and innovative ways to transport active ingredients, so that a large proportion of them do, indeed, make their way to their target, and more efficiently treat the disease.”

“New formulations are almost like completely new developed drugs. The ability to specify the drug’s transportation to the target organ is the essence of the technology we develop, and our main advantage as a company” she emphasizes, while also referring to the company’s ability to adapt the platform and transport technology to any active ingredient, so that it is ‘tailor made’ throughout the development process. “The technology that we developed is based on liquid nano-structures that are all of the same size and unique geometry, empowering us with many advantages. First, it enables us to adapt our API to the active ingredient in any drug. Second, the liquid drops we build simulate the natural systems found within the human body, while carrying high concentrations of the active ingredient. Third, it is able to extend the product’s chemical and physical stability, thereby increasing its shelf life.” The list of the advantages of the technology is long and very impressive.

A breakthrough solution that’s replacing “classic” formulations

During its early days the company focused on the research and developments that Prof. Garti had engaged in, throughout his many years in academia. It later became clear that those studies served as the foundation for the development of an innovative and breakthrough technology, one capable of resolving prevalent challenges within the pharmaceutical, health supplemental and derma cosmetic markets.

Throughout its various development processes, the company takes particular care to register new patents for every development and application, thus protecting its intellectual property. “Our broad platform enables us to adapt for each active molecule and administration method, thus birthing new dedicated patents. To date, the company has 7 ‘patent-families’ that are registered in several countries around the world, 14 of which are already approved, 37 are under examination, and few are still being written. All are based on our uniform liquid drop nanotechnology” says Dr. Garti-Levi.

Developing nanotechnology into a variety of administration methods, and partnering with national & multi-national companies

Over the years the technology has been developed, expanded, and adapted to meet the market’s needs and its accompanying regulatory requirements, across a variety of administration methods: oral (though the mouth), topical (on the surface, such as skin, nail, etc.), ophthalmic (as eye drops or gel) and more. Additionally, the company continuously strives to innovate, building the systems for each active ingredient using unique mathematical models that have since become their intellectual property as well.

Over the years, the company has entered into collaborations with several national and international companies, lending the use of its transport technology to different drugs and products. Some of the company’s developments are already for sale worldwide, while some are in advanced stages of development.

Blockbuster products – Within the framework of LDS’ vast activities across many fields and partnerships, a project with one of the largest international companies that relies on the LDS’ nanometric transport umbrella is getting ready to launch. “The project involves a blockbuster drug that is currently being reformulated in order to improve the drug’s efficacy. This will enable us to offer a more effective solution to many more patients, so they can enjoy a better quality of life,” Prof. Garti reports, adding that the company is also working in parallel on other very interesting projects.

Cannabis – The company is involved in multiple cannabis projects, including a collaboration with a US-based company ANANDA Scientific, which develops medical cannabis-based drugs and products. The products, intended for the OTC market and pharmaceutical drugs (RX) industry, are all based on LDS technology. There are currently four clinical studies underway on humans, under the supervision and approval of the FDA, some of which are even funded by the NIH, focusing to treat several diseases. The medical cannabis market is expected to increase by 25.7% in the upcoming years, and reach a whopping 2 billion dollars in sales by 2028.

Eye disorders and diseases – The company has collaborated on three projects with OphRx for the improvement of the effectiveness of current known eye medications, some of which target the front part of the eye, and others developments that treat the eye’s posterior (back) part. The global eye medication market is currently valued at roughly 31 billion dollars, and it is expected that this number will continue to climb by another 5.0% by 2027.

Psoriasis – Psoriasis is a chronic autoimmune disease that leads skin cells to shed at an unprecedented rate, due to their identification as pathogenic. Symptoms of the disease include mostly red-purple layers of skin that are covered in patches. The development of an innovative formulation for the drug’s transport by LDS, based on RNA molecules, was executed in collaboration with Prof. Yechezkel Sidi and Dr. Dror Avni, of Tel Hashomer Hospital.

Muscular dystrophy – Another project that’s at a very advanced stage seeks to cope with a rare form of muscular dystrophy, which is characterized as an orphan disease. “We created a formulation using the technology we’d developed, and adapted it to the pharmaceutical company’s requirements. Following lengthy discussions with the Ministry of Health, we received approval to use it as a compassionate treatment for two patients in Israel. We collaborated with Prof. Alexander Lossos and Dr. Or Kahlon of Hadassah Ein Kerem Hospital in Jerusalem, who have defined the disease and found the active molecule. The results were so phenomenal that, within just a few months from starting the treatment, the patients experienced exceptionally impressive motor improvements, which will lead to extended clinical trials in Israel and soon in the US,” Prof. Garti excitedly explains.

Nail fungus – One of the company’s projects focuses on a phenomenon that plagues 20-30% of the population – in Israel and the US – and increases in severity with age: nail fungus infection. The fungal infection takes over the nail’s surface and damages it, potentially leading to distortions, pain, and changes in the nail’s color and shape. The fungus can even lead to the nail breaking down and detaching from the finger. “There are quite a few solutions on the market, however those that are prescribed as oral treatments are not very recommended by the physicians, as they expose the entire body to the drug, leading to possible systemic problems. Additionally, there are several local treatments, but the effectiveness of most of these treatments is dubious at best; often, the fungus returns shortly after the course of treatment has been completed,” Dr. Garti-Levi explains. “Our technology and the project enables local treatment to be provided to the root of the problem, by applying a preparation that creates a clear, thin and flexible film over the nail. The film is loaded with millions of nanometric drops carrying the medication and enabling it to penetrate the nail. The drug is then released through the nail eradicating the fungus, providing real, long-term treatment.” Dr. Garti-Levi further explains that the product is presently undergoing clinical trial in collaboration with Prof. Avner Shemer, a world-renowned expert in the field of skin disease, specializing in nail fungus infections. The clinical trial will examine the treatment’s efficacy and safety on human patients. “This is an example of how we can target the nanotechnology we developed, so as to enhance the drug’s activity and make it more affordable and accessible to the entire population.” The American nail fungus treatment market was valued at 4 billion dollars in 2021 and it is expected to continue to grow to 5.6 billion dollars by 2025, at a CAGR of roughly 8.42%, while the global market is at least three times the size of the US market. Local nail fungus treatments alone are expected to be worth roughly 540 million dollars, by 2026.

Derma-cosmetics – The company has a new technology unit. The unit bases its innovations on unique and scientific models that utilize its nanometric drops to carry active molecules designed to improve and restore the skin’s appearance and provide better solution for derma-cosmetics products dealing with the skin’s health. The company’s products are clear gels that are pleasant to the touch and enable high levels of penetrability; their activity leads to visible results, in a relatively short amount of time.

LDS has recently signed few additional contracts for the development of new dermal treatment drugs with international collaborators and for the incorporation of nutraceuticals into food supplements utilizing it nano-technology.

Professional human capital as the foundation for success

According to Dr. Garti-Levi, the company has focused on recruiting talented, professional, and quality employees, since first opening its doors, as she believes that human capital directly influences the company’s success.

The company has also established labs and offices, and has acquired advanced analytical equipment to empower their research and development activities, allowing LDS to shift from performing basic academic research to regulatory-compliant technology development. “Our team is made up of researchers and scientists who’ve all completed advanced academic degrees. Most of them specialize in chemistry. Each and every employee is highly experienced, so as to help us achieve our goals and lead the company’s various projects, from research to commercialization and marketing,” she explains, detailing that the company is also supported by additional researchers, managers, and consultants, whose track records, experience, and expertise, help advance LDS’ activities.

The clinical trials and the study of the structures and models that work to release the drug are aided by the Hebrew University of Jerusalem’s laboratories and advanced analytical equipment, mainly those of the university’s “Nano Center” located near the company’s offices, in the Givat Ram campus, which neighborhood’s the high-tech park.

Significant activities and contributions to the community

Prof. Garti recounts that, alongside commercial motivations and activity within a competitive market, the company’s unique technology helps improve people’s quality of life. “We are working with something unique. Our globally patented nanotechnology concession benefits people around the world. It is important to note that all of the elements, including those that are inactive yet help to build the formulation, are safe for use and meet all international standards, including those of the FDA and EMA.”

Then, there’s the perspective of using the company to give back to the community through volunteering with children with special needs, and making other notable contributions. “The technology itself helps, as it enables medical treatments to be more affordable and effective, making many medications and OTC products more accessible,” Prof. Garti explains, adding that “some projects, such as the development for the orphan drug for muscular dystrophy, that I mentioned earlier, are promoted at this stage without any intention of achieving profitability. In this case, we decided to assume most of the development costs, so we could give back to society and help those patients who have no other solution, and suffer from poor quality of life.”

In collaboration with LDS