Drug delivery is a broad concept in the pharmaceutical industry. It involves different ways to administer medicines, as well as various techniques to formulate and manufacture drugs. Nanologica operates within a niche domain of the former which is called “nanocarriers”.
With the aid of nano-based drug delivery technologies, there is the potential to solve many global challenges which today impede or prevent effective treatment of serious diseases. These include the stabilization and controlled release of large molecules, such as peptides and proteins, which are used in biological drugs and in targeting cancer drugs at tumor tissue. Another option is to boost the body’s absorption of drugs that are poorly soluble in water. Poor solubility of a drug substance in water generally results in poor efficacy of the drug because the body is a water-based system, and the substance has to be in dissolved form to reach the place in the body where it is effective.
NLAB Silica™ involves porous particles in a micrometer format. Nanologica’s drug delivery technology can be described simply as loading the pores in the particles with a drug substance, and then compressing the particles into tablets. When the patient takes the tablet, the drug is gradually released into the stomach and/or intestines. The drug is then absorbed by the body, while the particles pass through and are excreted. By storing, stabilizing and transporting the drug substance inside the particles’ pores, the efficacy of the drug is maintained.
The pores in NLAB Silica™ particles (gray) are loaded with a drug substance (green), and the particles are then compressed into tablets. When the patient takes the tablet, the drug is gradually released into the stomach and/or intestines. The drug is then absorbed by the body, while the particles pass through and are excreted.
The most common problem with poorly soluble drug substances is that the natural state is a crystalline form which cannot be absorbed by the body, while the amorphous form which has a medical effect is unstable. By loading the unstable, amorphous form of the drug substance in NLAB Silica™, the substance is stabilized, which increases the body’s ability to absorb the drug. In this way, treatments can be made more effective, doses reduced and in some cases completely new drugs created.
Most research during the past few decades has resulted in new biological drugs which use large molecules, such as peptides and proteins, to treat diseases which have been difficult to treat with traditional drugs. Many of these new drugs have stability problems and disintegrate when handled. This problem can be resolved by loading the drug molecules into NLAB Silica™. Nanologica has conducted animal studies with the release of peptides from NLAB Silica™. The results were very promising and the patent application has been submitted.
NanoALS – Growth of stem cells
Together with a research group in Uppsala, Sweden, led by associate professor Elena Kozlova, Nanologica has developed a method for getting stem cells to grow and survive in environments where this has not been previously possible. This was achieved by loading NLAB Silica™ particles with growth factors.
Dr. Kozlova’s pioneering research has the potential for application in both the treatment of spinal injuries and the autoimmune disease amyotrophic lateral sclerosis (ALS). The NanoALS project was launched in 2015 and has the potential to develop a treatment which would make ALS a chronic rather than a fatal disease. The intellectual property rights to the project are owned by Nanologica. The project is being funded by the EU and has been undertaken by Dr. Kozlova’s group, together with five other research groups around the world. The project, which is in its early phase, has the potential for great advances in the long term. A number of animal studies have been carried out and new ones are planned for 2016 within the framework of the EU project.
Growth factors (peptides) loaded into NLAB Silica™ make stem cells grow and become more viable. The release is controlled and takes place over an extended period, which means that the stem cells both increase in number and are viable.
Project funding consists of a preliminary study with the stated objective of funding clinical studies in humans in the next phase. The project is associated with high technical risk and, at the same time, there is huge interest in the stem cell treatment of ALS.
Nanologica’s guiding principle is to be relevant to patients. For a drug delivery company, there are two ways to do this: develop your own drug or collaborate with existing pharmaceutical companies. Initially, Nanologica has chosen to focus on industrial collaboration because collaboration entails lower risk from several perspectives, above all developmentally, financially and commercially.
Industrial collaboration can be designed in different ways depending on what is being developed and how much interest there is on the part of the pharmaceutical company. Pharmaceutical companies in general often require a drug delivery company to bear its share of the costs of collaboration in relation to a given substance, and not receive payment until the project is extended either to clinical studies or to registered drugs.
In collaborative projects, Nanologica receives remuneration for delivered material and in most cases also for the patent platform. When the patent platform is vital for the final product, there is also the option of reimbursement in the form of milestones and royalties on future sales.
A schematic diagram of the various phases in which Nanologica is engaged by customers is shown below. The longer a project advances, the greater the earning potential for Nanologica.
Nanologica’s business model: the loaded particles symbolize evaluation projects, the tablets correspond to clinical studies and the tablet container signifies a finished product.
Nanologica has thus far carried out twelve feasibility studies together with pharmaceutical companies. For such projects, Nanologica receives remuneration which is intended to meet the costs of the company’s work in this stage. If, after evaluation, the pharmaceutical company decides to take the project into clinical studies, the remuneration to Nanologica becomes substantially greater and is expected to greatly exceed the costs for the company’s work in this stage. Clinical studies can be prepared and undertaken over many years; the period is shorter for generic drugs and longer for original drugs. If the development work ultimately results in a finished product, the remuneration to Nanologica is again expected to be significantly greater than for the work in clinical studies. Projects relating to generic drugs are generally more likely to reach market than projects which aim to develop original drugs.