The United States maintains a dominant position in the global pharmaceutical industry, accounting for 42.6% of the $1.48 trillion global pharmaceutical market. The country hosts some of the largest pharmaceutical companies globally, and American consumers have access to the most cutting-edge pharmaceutical products worldwide. A significant challenge currently confronting the pharmaceutical industry and drug development pertains to a substantial proportion (40 to 70%) of active pharmaceutical ingredients (API) exhibiting low water solubility, resulting in poor bioavailability and often therapeutic ineffectiveness. These hydrophobic molecules fall within the Biopharmaceutics Classification System (BCS) categories II and IV drugs. In light of this, the global market for BCS Class II and IV drugs could range from $600 billion to $1.036 trillion. The text later presents selected candidate APIs and their respective market sizes.
We have developed a nanotechnology approach referred to as n-Fast to enhance the bioavailability and effectiveness of Active Pharmaceutical Ingredient (API) crystals by improving their water solubility, essentially creating a fast-dissolving version of the drug (1-10). Our technology aims to reformulate various insoluble APIs, falling under BCS Class II and IV, with bioabsorbable, functionalized nanoparticles (FNPs) featuring surface hydrophilization to enhance solubility, and ultimately efficacy. We propose the direct incorporation of FNPs into drug crystals during their formation in a way that preserves the crystal structure, polymorph, and physicochemical properties. The mechanism of fast dissolution
Our initial work involved functionalized carbon nanotubes (fCNTs) and nano graphene oxide (nGO) as FNPs. While fCNTs and nGO showed excellent results, their potential cytotoxicity raised significant concerns. Consequently, with the help of previous TITA funds, we have commenced the development of FNPs using FDA-approved bioabsorbable polymers. We have now formed NEAT Biosciences as an official company with a strong leadership team possessing broad and deep expertise. The main use of the TITA-2026 funds from the proposed award will be to generate data for regulatory (FDA) validation. This will mainly involve in vivo studies in animal models—primarily rat and dog models—using selected APIs over a period of 0 to 18 months. At the same time, the team will engage biotech and specialty pharmaceutical companies to build awareness and interest in the platform. These efforts aim to secure one or two pre-licensing or co-development agreements that can generate early IND (Investigational New Drug)-development revenue.