Israeli novel drug delivery system en route to FDA approval, company says

A company based on technology developed at Hebrew University has now developed a series of patents that will allow the world to use certain drugs that were either not highly effective or not safe to use by enhancing their delivery.

Prof. Nissim Garti, who founded Lyotropic Delivery Systems (LDS) back in 2013, told The Jerusalem Post that his company has recently signed several new global contracts and his delivery system is now being tested in a series of preclinical and clinical trials. He expects to have at least one bioactive approved by the American Food and Drug Administration within two or three years.

LDS developed new molecular engineered nanostructures for enhanced and controlled delivery of soluble and insoluble active molecules. The word “lyotropic” is a word blending the sounds and combining the meanings of two others: lyo means "dissolve" and tropic means "change." 

Garti, who serves as the company’s CEO, worked in the field for more than 40 years through his roles at Hebrew University. He served as the director of the school’s Casali Institute of Applied Chemistry and was a consultant for global companies in the area before opening his own. He is also a Rockefeller Foundation Award recipient and served on the search committee for the Nobel Prize of Chemistry. 

 

He told the Post that unlike most delivery technologies that are based on solid particles or liquid formations, LDS “offers a novel approach based on molecular architectures, designed and engineered using unique computer mathematical simulation programs, taking into consideration the interfacial phenomena, optimum surface area, the release pattern of the active molecule, as well as additional parameters, in order to compose LDS’ liquid structures,” as it explains on the company website. 

The technology can be employed for a wide variety of applications, including oral, dermal, nasal, parenteral, ocular and more.

Garti was the one who discovered that nanodroplets are capable of entrapping active ingredients, such as drugs, at their interface, rather than in the droplets’ core. He made the first discovery during his time at HU and later developed it further through LDS. 

The platform allows drugs - innovative and generic - that would be insoluble in water and therefore not bioavailable to be transferred across cell membranes, something that in most cases is impossible. The drugs stay intact until they are released - in the case of oral intake - on demand at the correct location in the body. The carrier, once emptied of the drug it transported, is removed from the body through feces. 

Because the carriers are fully dilutable with water and not affected by the stomach’s pH, they do not cause any problems in the digestive tract. 

In January, LDS announced a clinical trial and collaboration with a US company, ANANDA, to evaluate the efficacy of cannabidiol using the delivery technology as a treatment for Post-Traumatic Stress Disorder symptoms and neurocognitive impairment in patients with PTSD and with PTSD comorbid with traumatic brain injury. 

ANANDA licensed the structure for the trial from LDS.

In addition, Garti’s company is working on a novel nail fungus treatment.

LDS is developing a thin, transparent, flexible, self-adhesive film in which drug molecules are embedded in nanodroplets. The structured film halts the spread of infection through the controlled release of therapeutics, which Garti said results in better performance and a better user experience.

“Nail fungus is basically incurable,” he told the Post,” despite the many devices and applications that aim to treat it. We can permeate the drug through the nail - not around it, but through it. We have proof that it works, and we are close to going to clinical trials here, too.”