Utilising cutting-edge water-based nanotechnology

By Ayelet Dilion-Mashiah

Bringing a new drug to market is one of the most expensive procedures in the business world. As the costs of new drug development currently weigh in at approximately $500 million, late-stage failure is a disaster for the company’s finances.

“The industry needs to recognise that an early-stage focus on the delivery system is experimentally prudent”
-Ayelet Dilion-Mashiah

Traditionally, the early-stage focus has been on toxicity, with the question of efficacy relegated to the later stages of the drug trials. This old paradigm – toxicity first, formulation later – has proven to be an enormous boondoggle, wasting the time and money of companies that utilise it. Studying dose response translation only in the late stages of phase III opens the door to disaster, as it is impossible to predict how a compound may impact the disease entity.

As a result, efficacy has finally become an integral part of early-stage drug development. However, it is still the standard operating procedure to use different vehicles at different stages of the research process. This can lead to unpredictable dose responses in human subjects, sometimes leading to catastrophic late-stage failures – precisely what the change in paradigm was designed to avoid.

The industry therefore needs to recognise that an early-stage focus on the delivery system is not only fiscally responsible, but experimentally prudent. DMSO has long been the vehicle of choice for solubilising hydrophobic and hydrophilic compounds. However, the use of DMSO and the sole focus on solubility has led us down the path of false assumption, leading to an increased potential for the dreaded late-stage failure.

Although it is possible to formulate virtually any drug into solubility in vitro; the focus must shift to bioavailability in vivo. This requires the identification of a medium ideal for both solubility and delivery, ensuring that it can both be delivered to the desired site and extracted to reach the targeted points on the cells.

The key issue regarding drug vehicles is hydrophilic versus hydrophobic properties. Delivery via bodily fluids demands that compounds be initially hydrophilic, and this becomes a problem at the cell membrane site, which is composed of hydrophobic lipids.

A great deal of attention has therefore been focused on using lipids to deliver drugs, such as liposomal vesicles. One key pitfall of these systems is that they are not inert, and contain other materials for the upload and release of the payload drug.

A safer, natural and more cost-effective solution has been found in Neowater. A unique form of water structured similarly to intracellular water, Neowater is composed of two hydrogen molecules and one oxygen molecule – the same basic chemistry as bulk water. The key difference is that the water molecules are organised in clusters and therefore feature different properties. Its key feature is the clusters’ very large surface area; this enhanced surface area is achieved by introducing nanoparticles to the water via a proprietary process.

Neowater’s post-production composition is distinct from regular water in that the CO2 concentration is 10- to 100-fold more. The enlarged surface area, due to the CO2 concentration, provides hydrophobic nuclei in the liquid phase. These characteristics result in an enhanced ability to disperse hydrophobic and hydrophilic compounds while simultaneously heightening bioavailability and stability.

The Neowater vehicle facilitates delivery of drugs by leveraging the surface effect. This differentiates the Neowater system from any other delivery system. However, as Neowater is a natural, general solution, it provides the same vehicle structure for many drug compounds, and requires only minimal customisation.

Now that there is a shift toward examining both toxicity and efficacy during the first stage of drug development in order to avoid the lack of predictability in later stages, use of standardised aqua-vehicle systems must be considered as the logical next stage in the process.

By leveraging Neowater, companies can now streamline the drug development process, moving from in vitro development to in vivo delivery, and from early laboratory experiments to late-stage studies in humans, with the same vehicle system. This eliminates the risk of needing to change the vehicle after all results are in, preventing the widely varying reliability that can result in late-stage failure – and the loss of significant capital.

Ayelet Dilion-Mashiah is the VP of Business Development and CFO of Do-Coop Technologies Ltd.