Before new medicines can reach the patients who need them, there is a huge amount of R&D that takes place to ensure drug safety and efficacy. From preliminary drug discovery research to drug development and progression through clinical trials, before finally reaching the market, the release of a novel therapy is the culmination of often upwards of 10 years’ hard work.
In spite of the extraordinary efforts and the significant financial investment behind every drug candidate, only a small fraction will ever make it through clinical trials – less than 10%. A major reason for this is poor solubility and bioavailability of drug candidates. More than 40 per cent of new chemical entities (NCEs) developed in the pharmaceutical industry exhibit poor aqueous solubility, and this issue is compounded by a trend towards more complex, hydrophobic molecules.
Creating a pathway for new drug candidates
There is a great need for innovative technologies that can improve the success rate for new drug candidates and pave the way for novel therapies to reach the market. Recent advances in nanoparticle engineering technology promise to accomplish precisely this. By increasing the surface area of drug compounds, solubility and bioavailability can be greatly improved. Another key benefit offered by nanoparticle engineering is a lowering of the dose required for therapeutic effect, which drives down manufacturing costs and waste.
Nanoform’s Controlled Expansion of Supercritical Fluids (CESS ®) nanoparticle engineering technology creates uniform nanoparticles from solution through a ‘bottom-up’ recrystallisation technique. Using this method, it is possible to create nanoparticles less than 200nm in size, and on occasion as small as 10nm. This is a major breakthrough. By decreasing particle size – and, by extension, increasing solubility and bioavailability – to this extent, the technology not only promises to enhance new therapies, but also opens up the possibility that novel drugs previously discarded due to solubility issues can be revisited.
Laying the groundwork for the future
In recognition of the power of Nanoform’s technology, the company has recently acquired GMP status to manufacture an investigational drug for use in human trials. To further propel its technology forward, Nanoform has also undergone a highly successful IPO in Sweden and Finland, during which company shares were oversubscribed. Nanoform’s launch as a public limited company resulted in a further $80 million in investment. Building on this strong foundation, Nanoform can now look forward to supporting an increasing number of drug development projects and to helping patients globally gain access to life-changing therapies more rapidly.